<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02215525</url>
  </required_header>
  <id_info>
    <org_study_id>EMMS 2014 1</org_study_id>
    <nct_id>NCT02215525</nct_id>
  </id_info>
  <brief_title>Treatment of Chronic HCV Infected Egyptian Patients With Electromagnetic Waves and Herbal Therapy</brief_title>
  <official_title>Treatment of Chronic HCV Infected Egyptian Patients With Electromagnetic Waves and Herbal Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Egyptian Military Medical Services</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>EMS</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Egyptian Military Medical Services</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Randomized, Open-Label, Study to evaluate and compare the efficacy and safety, of&#xD;
      extracorporeal irradiation of circulating blood by UVA with antioxidant as a supplement&#xD;
      (Selenium containing food supplement herbal tablets) in the treatment of non-cirrhotic&#xD;
      subjects with chronic hepatitis C.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives: To evaluate and compare the Efficacy and Safety, of extra-corporeal irradiation&#xD;
      of circulating blood by extra-corporeal electro-magnetic irradiation with Selenium containing&#xD;
      food supplement herbal tablets in the treatment of non-cirrhotic subjects with chronic&#xD;
      hepatitis C.&#xD;
&#xD;
      Background and Rationale: As many as 150 million persons are chronically infected with the&#xD;
      hepatitis C virus (HCV) worldwide, and more than 350,000 die annually from liver disease&#xD;
      caused by HCV&#xD;
&#xD;
      Egypt is confronted with an HCV disease burden of historical proportions that distinguishes&#xD;
      this nation from others. It has the highest prevalence of hepatitis C virus (HCV) in the&#xD;
      world, estimated nationally at 14.7% . Approximately, there are 10 million Egyptians carry&#xD;
      the virus. Due to its chronic debilitating nature, it has tremendous social and financial&#xD;
      impacts on our community. Hence, this trial aims to find a logic rational and effective&#xD;
      treatment for Hepatitis C.&#xD;
&#xD;
      Extra-corporeal electro-magnetic irradiation: The wavelength of UV irradiation (UVI) lies in&#xD;
      the range of 100-400 nm, and is further subdivided into UVA (315-400 nm), UVB (280-315 nm),&#xD;
      and UVC (100-280 nm).UVC and UVB are directly absorbed by DNA bases causing serious DNA&#xD;
      damages. On the other hand, DNA damage by UVA is indirect through the formation of Reactive&#xD;
      Oxygen Species (ROS) that are formed when other cellular chromophores act as endogenous photo&#xD;
      sensitizers. ROS can then react with and damage DNA, or interact with other cell structures&#xD;
      such as membranes (lipids) and proteins. All of these different types of damage may hamper&#xD;
      cell metabolic processes, such as protein synthesis and cell cycle progression, or induce&#xD;
      mutations and cell death . Both Selenium itself and various selenoproteins are proposed to&#xD;
      have antioxidant effects, reducing the biological impact of ROS on human cells .&#xD;
&#xD;
      Ultraviolet blood irradiation (UBI) was first used on humans in the early 1930s. The&#xD;
      effectiveness of UBI in treating infections was studied extensively in the 1940s and it was&#xD;
      found that UBI was extremely successful in treating such infections as peritonitis, pyelitis,&#xD;
      sinusitis, puerperal sepsis and wound infections in all but the most advanced cases.Later&#xD;
      studies showed UBI helped a number of patients with acute viral hepatitis .Recently, Energex&#xD;
      Systems, a developer of advanced UBI technology, studied the effects of UBI therapy on viral&#xD;
      loads in 13 patients with the infection and it showed some effect.&#xD;
&#xD;
      Optical and physical characteristics of electro-magnetic irradiation is the narrow band of&#xD;
      ultraviolet A radiation with a peak at 365 nm with an average power about 18 µW/cm2 during&#xD;
      the session.&#xD;
&#xD;
      For irradiation in the UVA region (315 nm- 400nm) the measured average irradiance was 0.12&#xD;
      mW/cm2in the place of circulating blood at any time of each session(40 sec).&#xD;
&#xD;
      The time integral of irradiance (prescribed exposure dose) is 0.144 J/cm2(1440 J/m2)for total&#xD;
      radiant exposure time of 1200 sec (20 min) in all therapeutic sessions (up to maximum of 30&#xD;
      sessions in some particular cases).&#xD;
&#xD;
      The Irradiance power at all bands of output wavelength (250 nm - 1050 nm) from the optical&#xD;
      lamps:&#xD;
&#xD;
      Wavelength (nm) Irradiance Power (mW/cm2) Ultraviolet Region A: UVA (315 nm -400 nm) 0.12&#xD;
      mW/cm2 Visible Band: VIS (400 nm - 700 nm) 110.8mW/cm2 Infrared Band: IR (700 nm - 1050 nm)&#xD;
      28.3mW/cm2&#xD;
&#xD;
      Selenium containing herbal food supplement:&#xD;
&#xD;
      No. Name Action&#xD;
&#xD;
        1. Ginseng Liver tonic&#xD;
&#xD;
        2. Saffron Anti - Oxidant&#xD;
&#xD;
        3. Dandelion Anti - Bacterial&#xD;
&#xD;
        4. Curcuma Anti - Parasitic&#xD;
&#xD;
        5. Vinca Rose Anti - Bacterial&#xD;
&#xD;
        6. Wormwood Anti - Oxidant&#xD;
&#xD;
        7. Lemon balm Anti - Bacterial&#xD;
&#xD;
        8. Papay Anti - viral&#xD;
&#xD;
        9. Achillia Anti - viral&#xD;
&#xD;
       10. Arctium Anti - viral&#xD;
&#xD;
       11. Aloe Anti - viral Anti - bacterial Anti - Fungal&#xD;
&#xD;
       12. Asfour Liver support&#xD;
&#xD;
      Detailed Description A Randomized, Open-Label, Study to investigate the Efficacy and Safety&#xD;
      of extra-corporeal irradiation of circulating blood with and Selenium containing herbal food&#xD;
      supplement tablets in the treatment of non-cirrhotic chronic hepatitis C subjects.&#xD;
&#xD;
      The null hypothesis: There is no difference in outcomes and cure rate of patients with&#xD;
      Hepatitis C when using electromagnetic device or herbal tablets containing selenium are used&#xD;
      with aim of treatment.&#xD;
&#xD;
      This study was submitted for ethical approval via the relevant Minister of health and Medical&#xD;
      military sector Research Ethics Approval Committees.&#xD;
&#xD;
      Study Arm (s)&#xD;
&#xD;
      Interventions (arm 1):&#xD;
&#xD;
      Twenty four daily one hour sessions using Extra-corporeal electro-magnetic irradiation device&#xD;
      combined with Herbal Food Supplement Selenium containing tables as an Anti Oxidant (Tablet A)&#xD;
      starting 10 days before the radiation sessions and to continue for 24 weeks.&#xD;
&#xD;
      Intervention (arm 2):&#xD;
&#xD;
      Daily Herbal Food Supplement Selenium containing tablets for 24 weeks. What will happen to&#xD;
      patients?&#xD;
&#xD;
        1. Invitation to participate:&#xD;
&#xD;
           Patients with hepatitis C virus infection will be identified from the attendee of the&#xD;
           hepatology and tropical diseases clinics at our institute.&#xD;
&#xD;
        2. First Contact:&#xD;
&#xD;
           Each patient will then receive a phone call from the Research Nurse, to request an&#xD;
           indication of whether they would like to participate in the study. If the patient would&#xD;
           like to meet face-to-face, in which case arrangement would be made during the&#xD;
           investigation tests or outpatient clinic appointments. Otherwise, questions will be&#xD;
           answered over the telephone. This phone call is anticipated to last 10 minutes on&#xD;
           average.&#xD;
&#xD;
        3. Initial Assessment Meeting and Informed Consent:&#xD;
&#xD;
           An initial meeting will then take place at which patients will be asked to give their&#xD;
           informed consent.&#xD;
&#xD;
           In addition, demographics, past medical history and baseline observations will be noted.&#xD;
           Up-to-date base line investigations will be performed including: FBC, renal functions,&#xD;
           liver profile, Viral load PCR. The patients will then be informed of which group they&#xD;
           have been randomized into (electromagnetic or herbal tablets). Patients in each group&#xD;
           will have a detailed explanation of their corresponding management and booklet will be&#xD;
           given to patients to take home.&#xD;
&#xD;
        4. The Electromagnetic Device group:&#xD;
&#xD;
           Those participants in the intervention group will be invited to attend the treatment&#xD;
           cubicles to see the device. They will receive 20 minutes presentation about the theory&#xD;
           of the device and how it functions.&#xD;
&#xD;
        5. Repeated Assessment Meetings:&#xD;
&#xD;
             -  The Assessments performed in 3 above, will be repeated:&#xD;
&#xD;
             -  On discharge (-24hrs to +48hrs) with additional returning to normal activities&#xD;
                questions.&#xD;
&#xD;
             -  4-week out-patient appointment in research team clinic.&#xD;
&#xD;
             -  8-week out-patient appointment in research team clinic&#xD;
&#xD;
             -  12-week out-patient appointment in research team clinic.&#xD;
&#xD;
             -  24-week out-patient appointment in research team clinic.&#xD;
&#xD;
        6. Monitoring and Supportive Meetings:&#xD;
&#xD;
           • The research nurse will be available on the study mobile phone which will be supported&#xD;
           by other members of the research team during periods of leave.&#xD;
&#xD;
        7. End of the study:&#xD;
&#xD;
      A final assessment meeting will take place six month after completion of treatment.&#xD;
      Participants will be discharged back to the hepatology clinic for long term management.&#xD;
      Research team will be notified of any long term adverse effects of either treatment arms.&#xD;
&#xD;
      Last follow up date: 48 weeks from baseline. Recruitment Status: Currently recruiting.&#xD;
&#xD;
      Supervision:&#xD;
&#xD;
        1. The Management and Monitoring Group (MMG). The study will be managed by a 'Management&#xD;
           and Monitoring Group' (MMG) which will meet regularly, throughout the study, to manage&#xD;
           it and to monitor progress. A Gantt chart showing the points at which MMG meetings are&#xD;
           proposed is provided within the appendices. The study management will also comprise 5&#xD;
           sub-groups (involving specialized experts) who will interact with the MMG. A schematic&#xD;
           showing all of these study management groups is given in the appendices of this&#xD;
           document.&#xD;
&#xD;
           The MMG will comprise:&#xD;
&#xD;
             -  Patient Representative.&#xD;
&#xD;
             -  Professor Doctor: Tayseer Abdulaal, M.D., Internal medicine, Clinical Immunology&#xD;
                Consultant, Egyptian Military Armed Forces&#xD;
&#xD;
             -  Professor Doctor: Mostafa El-Awady, M.D.,Molecular Biology Consultant, Egyptian&#xD;
                National Research Center&#xD;
&#xD;
             -  Professor Doctor: Mostafa El-Nakib, M.D., Virology Consultant, Egyptian Military&#xD;
                Armed Forces&#xD;
&#xD;
             -  Professor Doctor: Hala Zayed, M.D., Internal medicine, Clinical Immunology&#xD;
                Consultant, Egyptian Ministry of Health&#xD;
&#xD;
             -  Professor Doctor: Ahmed El-Sawy, M.D., Gastroenterology Consultant, Egyptian&#xD;
                Military Armed ForcesDr&#xD;
&#xD;
        2. The Patient Experience Sub-group The principal sub-group of the MMG will be one who will&#xD;
           take responsibility for managing and monitoring the experiences of all patients during&#xD;
           the study. This group will comprise Dr Tayseer Abdulaal and the Research Nurses and the&#xD;
           Administrator. Therefore, it will be based within the hospital. This group will also be&#xD;
           responsible for patient recruitment and for patient data entry onto an appropriate&#xD;
           database. This group will make a significant contribution to the overall management of&#xD;
           the study (which is done by the MMG) by raising awareness, within that group, of issues&#xD;
           relating to all aspects of patient experience that arise as the study progresses.&#xD;
&#xD;
        3. The Critical side effects Sub-group A team of researchers, based at Egyptian military&#xD;
           hospital, Ain Shams and Cairo University hospitals will meet within 24 hours of&#xD;
           admission of any patients involved in the trial to any of the designated hospital. An&#xD;
           action plan will include a thorough evaluation of the patient condition. Ife there is&#xD;
           any concern regarding patient safety; the trial will be suspended for further&#xD;
           assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2014</start_date>
  <completion_date type="Anticipated">May 2015</completion_date>
  <primary_completion_date type="Anticipated">October 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>sustained virological response (SVR) at 12 weeks</measure>
    <time_frame>12 weeks after the end of treatment</time_frame>
    <description>SVR is defined as an absence of detectable HCV RNA in the serum with use of an assay with a sensitivity of at least 50 IU/mL.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sustained Virological Response (SVR) at 24 weeks</measure>
    <time_frame>24 weeks after completion of the course of treatment.</time_frame>
    <description>Absence of detectable HCV RNA in the serum with use of an assay with a sensitivity of at least 50 IU/mL.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>UVA and Herbal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twenty four daily one hour sessions using Extra-corporeal electro-magnetic irradiation device combined with Herbal Food Supplement Selenium containing tables as an Anti Oxidant (Tablet A) starting 10 days before the radiation sessions and to continue for 24 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Herbal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chronic HCV patients, non complicated will be treated by Herbal tablets only . 500 mg twice tablets every 6 hours daily for 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>UVA</intervention_name>
    <description>device uses UVA</description>
    <arm_group_label>UVA and Herbal</arm_group_label>
    <other_name>UVA device</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Herbal</intervention_name>
    <description>Herbal tablets, 1000 mg every 6 hours daily for 6 months</description>
    <arm_group_label>Herbal</arm_group_label>
    <other_name>Herbal tablets</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female between the age of 21 and 60 years.&#xD;
&#xD;
          2. Female subjects of childbearing potential must be willing to use effective form of&#xD;
             birth control.&#xD;
&#xD;
          3. Sexually active fertile females in childbearing period must have negative results for&#xD;
             pregnancy tests.&#xD;
&#xD;
          4. Sexually active fertile males must agree either him or his wife to practicing&#xD;
             effective form of birth control.&#xD;
&#xD;
          5. Subject should be treatment: Non cirrhotic HCV chronic Hepatitis.&#xD;
&#xD;
          6. Subjects must be able to understand and to adhere to the study visits schedule.&#xD;
&#xD;
          7. Body mass index (BMI) is &gt;18 to &lt;35kg/m2.&#xD;
&#xD;
          8. Must voluntarily sign and date an informed consent, approved by an Institutional&#xD;
             Review Board/Ethics Committee (IRB/EC), prior to the initiation of any study-specific&#xD;
             procedures.&#xD;
&#xD;
          9. Chronic HCV for at least 6 months prior to study enrolment. Chronic HCV infection is&#xD;
             defined as one of the following:&#xD;
&#xD;
               -  Positive for anti-HCV antibody or HCV RNA at least 6 months before Screening, and&#xD;
                  positive for HCV RNA and anti-HCV antibody at the time of Screening; OR&#xD;
&#xD;
               -  Positive for anti-HCV antibody and HCV RNA at the time of Screening with a liver&#xD;
                  biopsy consistent with chronic HCV infection (or a liver biopsy performed prior&#xD;
                  to enrolment with evidence of chronic hepatitis C disease).&#xD;
&#xD;
         10. Absence of cirrhosis judged by documented results of :-&#xD;
&#xD;
               -  Liver Ultrasound. OR&#xD;
&#xD;
               -  Fibro Test score of ≤ 0.75 and Aspartate Amino transferase to Platelet Ratio&#xD;
                  Index (APRI) ((AST/AST ULN)X100)/Plt in thousands) ≤ 2 at Screening, OR&#xD;
&#xD;
               -  FibroScan® result of &lt;14.5kPa, OR&#xD;
&#xD;
               -  The absence of cirrhosis based on a liver biopsy within the last 36months.&#xD;
&#xD;
         11. If the rewire multiple assessments on the same date for a subject, fibrosis score was&#xD;
             calculated in the order of liver biopsy, FibroScan, and Fibro Test. If the rewire&#xD;
             assessments on different dates for a subject by different methods, fibrosis score was&#xD;
             calculated n the order of liver biopsy, FibroScan, and Fibro Test. If the rewire&#xD;
             assessments on different dates for a subject by the same method, fibrosis score was&#xD;
             calculated by maximum value.&#xD;
&#xD;
         12. Subject has a plasma HCV RNA level &gt;10,000 International Units (IU)/mLat screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of severe, life-threatening or other significant sensitivity to any drug.&#xD;
&#xD;
          2. Females who are pregnant or breast feeding.&#xD;
&#xD;
          3. Recent (within 6-months prior to study drug administration) history of drug or alcohol&#xD;
             abuse that could preclude adherence to the protocol.&#xD;
&#xD;
          4. Positive test result for hepatitis B surface antigen (HbsAg) or anti-HIV antibodies&#xD;
             (anti-HIV Ab).&#xD;
&#xD;
          5. Clinically significant abnormalities, other than HCV infection, based upon the results&#xD;
             of a medical history, physical examination, vital signs, laboratory profile, a 12-lead&#xD;
             electrocardiogram (ECG) and echocardiography that make the subject an unsuitable&#xD;
             candidate for this study in the opinion of the Investigator.&#xD;
&#xD;
          6. History of uncontrolled seizures, cancer, or uncontrolled diabetes, as defined by a&#xD;
             HbA1C level &gt;8.0%.&#xD;
&#xD;
          7. Any current or past clinical evidence of cirrhosis , a history or presence of ascites,&#xD;
             oesophageal varices, or hepatic encephalopathy.&#xD;
&#xD;
          8. Known cause of liver disease other than chronic HCV infection.&#xD;
&#xD;
          9. Screening laboratory analyses show any of the following abnormal laboratory results:&#xD;
&#xD;
               -  Alanine amino transferase (ALT) &gt;5X upper limit of normal (ULN),&#xD;
&#xD;
               -  Aspartate amino transferase (AST) &gt;5X upper limit of normal (ULN),&#xD;
&#xD;
               -  Calculated creatinine clearance (using Cockcroft-Gault method) &lt;50mL/min,&#xD;
&#xD;
               -  Albumin&lt;lower limit of normal (LLN),&#xD;
&#xD;
               -  Prothrombin time INR &gt; 1.5,&#xD;
&#xD;
               -  Haemoglobin &lt; 11 %,&#xD;
&#xD;
               -  Platelets&lt;120,000cellsper mm3&#xD;
&#xD;
               -  Absolute neutrophil count &lt;1500cells/µL,&#xD;
&#xD;
               -  Total bilirubin&gt; 1.5 mg/dL,&#xD;
&#xD;
         10. Clinically significant abnormal echocardiography or ECG.&#xD;
&#xD;
         11. Any contraindications to central venous catheter insertion.&#xD;
&#xD;
         12. Previous history of photosensitivity, skin cancer or presence of a positive family&#xD;
             history of Skin Cancer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tayseer A Abdulaal, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>EMMS</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tayseer A Abdulaal, M.D.</last_name>
    <phone>+201223407675</phone>
    <email>tayseer70@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>EMMS</name>
      <address>
        <city>Cairo</city>
        <state>Heliopolis</state>
        <zip>11613</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tayseer A Abdulaal, M.D.</last_name>
      <phone>+201223407675</phone>
      <email>tayseer70@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Tayseer A Abdulaal, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>http://www.hepatitiscentral.com/mt/archives/2007/08/light_therapy_a.html</url>
    <description>New Technology and Methods to Fight Hepatitis C. Nicole Cutler L.Ac. August 6, 2007.</description>
  </link>
  <reference>
    <citation>Lindsay KL. Introduction to therapy of hepatitis C. Hepatology. 2002 Nov;36(5 Suppl 1):S114-20. doi: 10.1053/jhep.2002.36226.</citation>
    <PMID>12407584</PMID>
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  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 24, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 11, 2014</last_update_submitted>
  <last_update_submitted_qc>August 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HCV</keyword>
  <keyword>UVA</keyword>
  <keyword>Herbal therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02215525
org study id: EMMS 2014 1
nct id: NCT02215525
lead sponsor: 
collaborator: 
has dmc: Yes
A Randomized, Open-Label, Study to evaluate and compare the efficacy and safety, of
      extracorporeal irradiation of circulating blood by UVA with antioxidant as a supplement
      (Selenium containing food supplement herbal tablets) in the treatment of non-cirrhotic
      subjects with chronic hepatitis C.
Objectives: To evaluate and compare the Efficacy and Safety, of extra-corporeal irradiation
      of circulating blood by extra-corporeal electro-magnetic irradiation with Selenium containing
      food supplement herbal tablets in the treatment of non-cirrhotic subjects with chronic
      hepatitis C.

      Background and Rationale: As many as 150 million persons are chronically infected with the
      hepatitis C virus (HCV) worldwide, and more than 350,000 die annually from liver disease
      caused by HCV

      Egypt is confronted with an HCV disease burden of historical proportions that distinguishes
      this nation from others. It has the highest prevalence of hepatitis C virus (HCV) in the
      world, estimated nationally at 14.7% . Approximately, there are 10 million Egyptians carry
      the virus. Due to its chronic debilitating nature, it has tremendous social and financial
      impacts on our community. Hence, this trial aims to find a logic rational and effective
      treatment for Hepatitis C.

      Extra-corporeal electro-magnetic irradiation: The wavelength of UV irradiation (UVI) lies in
      the range of 100-400 nm, and is further subdivided into UVA (315-400 nm), UVB (280-315 nm),
      and UVC (100-280 nm).UVC and UVB are directly absorbed by DNA bases causing serious DNA
      damages. On the other hand, DNA damage by UVA is indirect through the formation of Reactive
      Oxygen Species (ROS) that are formed when other cellular chromophores act as endogenous photo
      sensitizers. ROS can then react with and damage DNA, or interact with other cell structures
      such as membranes (lipids) and proteins. All of these different types of damage may hamper
      cell metabolic processes, such as protein synthesis and cell cycle progression, or induce
      mutations and cell death . Both Selenium itself and various selenoproteins are proposed to
      have antioxidant effects, reducing the biological impact of ROS on human cells .

      Ultraviolet blood irradiation (UBI) was first used on humans in the early 1930s. The
      effectiveness of UBI in treating infections was studied extensively in the 1940s and it was
      found that UBI was extremely successful in treating such infections as peritonitis, pyelitis,
      sinusitis, puerperal sepsis and wound infections in all but the most advanced cases.Later
      studies showed UBI helped a number of patients with acute viral hepatitis .Recently, Energex
      Systems, a developer of advanced UBI technology, studied the effects of UBI therapy on viral
      loads in 13 patients with the infection and it showed some effect.

      Optical and physical characteristics of electro-magnetic irradiation is the narrow band of
      ultraviolet A radiation with a peak at 365 nm with an average power about 18 µW/cm2 during
      the session.

      For irradiation in the UVA region (315 nm- 400nm) the measured average irradiance was 0.12
      mW/cm2in the place of circulating blood at any time of each session(40 sec).

      The time integral of irradiance (prescribed exposure dose) is 0.144 J/cm2(1440 J/m2)for total
      radiant exposure time of 1200 sec (20 min) in all therapeutic sessions (up to maximum of 30
      sessions in some particular cases).

      The Irradiance power at all bands of output wavelength (250 nm - 1050 nm) from the optical
      lamps:

      Wavelength (nm) Irradiance Power (mW/cm2) Ultraviolet Region A: UVA (315 nm -400 nm) 0.12
      mW/cm2 Visible Band: VIS (400 nm - 700 nm) 110.8mW/cm2 Infrared Band: IR (700 nm - 1050 nm)
      28.3mW/cm2

      Selenium containing herbal food supplement:

      No. Name Action

        1. Ginseng Liver tonic

        2. Saffron Anti - Oxidant

        3. Dandelion Anti - Bacterial

        4. Curcuma Anti - Parasitic

        5. Vinca Rose Anti - Bacterial

        6. Wormwood Anti - Oxidant

        7. Lemon balm Anti - Bacterial

        8. Papay Anti - viral

        9. Achillia Anti - viral

       10. Arctium Anti - viral

       11. Aloe Anti - viral Anti - bacterial Anti - Fungal

       12. Asfour Liver support

      Detailed Description A Randomized, Open-Label, Study to investigate the Efficacy and Safety
      of extra-corporeal irradiation of circulating blood with and Selenium containing herbal food
      supplement tablets in the treatment of non-cirrhotic chronic hepatitis C subjects.

      The null hypothesis: There is no difference in outcomes and cure rate of patients with
      Hepatitis C when using electromagnetic device or herbal tablets containing selenium are used
      with aim of treatment.

      This study was submitted for ethical approval via the relevant Minister of health and Medical
      military sector Research Ethics Approval Committees.

      Study Arm (s)

      Interventions (arm 1):

      Twenty four daily one hour sessions using Extra-corporeal electro-magnetic irradiation device
      combined with Herbal Food Supplement Selenium containing tables as an Anti Oxidant (Tablet A)
      starting 10 days before the radiation sessions and to continue for 24 weeks.

      Intervention (arm 2):

      Daily Herbal Food Supplement Selenium containing tablets for 24 weeks. What will happen to
      patients?

        1. Invitation to participate:

           Patients with hepatitis C virus infection will be identified from the attendee of the
           hepatology and tropical diseases clinics at our institute.

        2. First Contact:

           Each patient will then receive a phone call from the Research Nurse, to request an
           indication of whether they would like to participate in the study. If the patient would
           like to meet face-to-face, in which case arrangement would be made during the
           investigation tests or outpatient clinic appointments. Otherwise, questions will be
           answered over the telephone. This phone call is anticipated to last 10 minutes on
           average.

        3. Initial Assessment Meeting and Informed Consent:

           An initial meeting will then take place at which patients will be asked to give their
           informed consent.

           In addition, demographics, past medical history and baseline observations will be noted.
           Up-to-date base line investigations will be performed including: FBC, renal functions,
           liver profile, Viral load PCR. The patients will then be informed of which group they
           have been randomized into (electromagnetic or herbal tablets). Patients in each group
           will have a detailed explanation of their corresponding management and booklet will be
           given to patients to take home.

        4. The Electromagnetic Device group:

           Those participants in the intervention group will be invited to attend the treatment
           cubicles to see the device. They will receive 20 minutes presentation about the theory
           of the device and how it functions.

        5. Repeated Assessment Meetings:

             -  The Assessments performed in 3 above, will be repeated:

             -  On discharge (-24hrs to +48hrs) with additional returning to normal activities
                questions.

             -  4-week out-patient appointment in research team clinic.

             -  8-week out-patient appointment in research team clinic

             -  12-week out-patient appointment in research team clinic.

             -  24-week out-patient appointment in research team clinic.

        6. Monitoring and Supportive Meetings:

           • The research nurse will be available on the study mobile phone which will be supported
           by other members of the research team during periods of leave.

        7. End of the study:

      A final assessment meeting will take place six month after completion of treatment.
      Participants will be discharged back to the hepatology clinic for long term management.
      Research team will be notified of any long term adverse effects of either treatment arms.

      Last follow up date: 48 weeks from baseline. Recruitment Status: Currently recruiting.

      Supervision:

        1. The Management and Monitoring Group (MMG). The study will be managed by a 'Management
           and Monitoring Group' (MMG) which will meet regularly, throughout the study, to manage
           it and to monitor progress. A Gantt chart showing the points at which MMG meetings are
           proposed is provided within the appendices. The study management will also comprise 5
           sub-groups (involving specialized experts) who will interact with the MMG. A schematic
           showing all of these study management groups is given in the appendices of this
           document.

           The MMG will comprise:

             -  Patient Representative.

             -  Professor Doctor: Tayseer Abdulaal, M.D., Internal medicine, Clinical Immunology
                Consultant, Egyptian Military Armed Forces

             -  Professor Doctor: Mostafa El-Awady, M.D.,Molecular Biology Consultant, Egyptian
                National Research Center

             -  Professor Doctor: Mostafa El-Nakib, M.D., Virology Consultant, Egyptian Military
                Armed Forces

             -  Professor Doctor: Hala Zayed, M.D., Internal medicine, Clinical Immunology
                Consultant, Egyptian Ministry of Health

             -  Professor Doctor: Ahmed El-Sawy, M.D., Gastroenterology Consultant, Egyptian
                Military Armed ForcesDr

        2. The Patient Experience Sub-group The principal sub-group of the MMG will be one who will
           take responsibility for managing and monitoring the experiences of all patients during
           the study. This group will comprise Dr Tayseer Abdulaal and the Research Nurses and the
           Administrator. Therefore, it will be based within the hospital. This group will also be
           responsible for patient recruitment and for patient data entry onto an appropriate
           database. This group will make a significant contribution to the overall management of
           the study (which is done by the MMG) by raising awareness, within that group, of issues
           relating to all aspects of patient experience that arise as the study progresses.

        3. The Critical side effects Sub-group A team of researchers, based at Egyptian military
           hospital, Ain Shams and Cairo University hospitals will meet within 24 hours of
           admission of any patients involved in the trial to any of the designated hospital. An
           action plan will include a thorough evaluation of the patient condition. Ife there is
           any concern regarding patient safety; the trial will be suspended for further
           assessment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: sustained virological response (SVR) at 12 weeks
time frame: 12 weeks after the end of treatment
description: SVR is defined as an absence of detectable HCV RNA in the serum with use of an assay with a sensitivity of at least 50 IU/mL.
measure: Sustained Virological Response (SVR) at 24 weeks
time frame: 24 weeks after completion of the course of treatment.
description: Absence of detectable HCV RNA in the serum with use of an assay with a sensitivity of at least 50 IU/mL.
arm group label: UVA and Herbal
arm group type: Experimental
description: Twenty four daily one hour sessions using Extra-corporeal electro-magnetic irradiation device combined with Herbal Food Supplement Selenium containing tables as an Anti Oxidant (Tablet A) starting 10 days before the radiation sessions and to continue for 24 weeks
arm group label: Herbal
arm group type: Experimental
description: Chronic HCV patients, non complicated will be treated by Herbal tablets only . 500 mg twice tablets every 6 hours daily for 6 months.
intervention type: Device
intervention name: UVA
description: device uses UVA
arm group label: UVA and Herbal
other name: UVA device
intervention type: Dietary Supplement
intervention name: Herbal
description: Herbal tablets, 1000 mg every 6 hours daily for 6 months
arm group label: Herbal
other name: Herbal tablets
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Tayseer A Abdulaal, M.D.
role: Principal Investigator
affiliation: EMMS
last name: Tayseer A Abdulaal, M.D.
phone: +201223407675
email: tayseer70@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Egypt
url: http://www.hepatitiscentral.com/mt/archives/2007/08/light_therapy_a.html
description: New Technology and Methods to Fight Hepatitis C. Nicole Cutler L.Ac. August 6, 2007.
citation: Lindsay KL. Introduction to therapy of hepatitis C. Hepatology. 2002 Nov;36(5 Suppl 1):S114-20. doi: 10.1053/jhep.2002.36226.
PMID: 12407584
citation: Ghany MG, Strader DB, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009 Apr;49(4):1335-74. doi: 10.1002/hep.22759. No abstract available.
PMID: 19330875
citation: Zeuzem S, Heathcote EJ, Shiffman ML, Wright TL, Bain VG, Sherman M, Feinman SV, Fried MW, Rasenack J, Sarrazin C, Jensen DM, Lin A, Hoffman JH, Sedarati F. Twelve weeks of follow-up is sufficient for the determination of sustained virologic response in patients treated with interferon alpha for chronic hepatitis C. J Hepatol. 2003 Jul;39(1):106-11. doi: 10.1016/s0168-8278(03)00187-9.
PMID: 12821051
citation: Martinot-Peignoux M, Stern C, Maylin S, Ripault MP, Boyer N, Leclere L, Castelnau C, Giuily N, El Ray A, Cardoso AC, Moucari R, Asselah T, Marcellin P. Twelve weeks posttreatment follow-up is as relevant as 24 weeks to determine the sustained virologic response in patients with hepatitis C virus receiving pegylated interferon and ribavirin. Hepatology. 2010 Apr;51(4):1122-6. doi: 10.1002/hep.23444.
PMID: 20069649
citation: Mohamoud YA, Mumtaz GR, Riome S, Miller D, Abu-Raddad LJ. The epidemiology of hepatitis C virus in Egypt: a systematic review and data synthesis. BMC Infect Dis. 2013 Jun 24;13:288. doi: 10.1186/1471-2334-13-288.
PMID: 23799878
citation: Moysan A, Marquis I, Gaboriau F, Santus R, Dubertret L, Morliere P. Ultraviolet A-induced lipid peroxidation and antioxidant defense systems in cultured human skin fibroblasts. J Invest Dermatol. 1993 May;100(5):692-8. doi: 10.1111/1523-1747.ep12472352.
PMID: 8491992
citation: Ridley AJ, Whiteside JR, McMillan TJ, Allinson SL. Cellular and sub-cellular responses to UVA in relation to carcinogenesis. Int J Radiat Biol. 2009 Mar;85(3):177-95. doi: 10.1080/09553000902740150.
PMID: 19296341
citation: Girard PM, Pozzebon M, Delacote F, Douki T, Smirnova V, Sage E. Inhibition of S-phase progression triggered by UVA-induced ROS does not require a functional DNA damage checkpoint response in mammalian cells. DNA Repair (Amst). 2008 Sep 1;7(9):1500-16. doi: 10.1016/j.dnarep.2008.05.004. Epub 2008 Jul 7.
PMID: 18603484
citation: Ferguson LR, Karunasinghe N, Zhu S, Wang AH. Selenium and its' role in the maintenance of genomic stability. Mutat Res. 2012 May 1;733(1-2):100-10. doi: 10.1016/j.mrfmmm.2011.12.011. Epub 2012 Jan 5.
PMID: 22234051
citation: MILEY G, CHRISTENSEN JA. Ultraviolet blood irradiation therapy; further studies in acute infections. Am J Surg. 1947 Apr;73(4):486-93. doi: 10.1016/0002-9610(47)90330-9. No abstract available.
PMID: 20290583
citation: Efficacy of ultraviolet blood irradiation therapy in the control of staphylococcemias. The American Journal of Surgery, Volume 64, Issue 3, June 1944, Pages 313-322
citation: OLNEY RC. Treatment of viral hepatitis with the Knott technic of blood irradiation. Am J Surg. 1955 Sep;90(3):402-9. doi: 10.1016/0002-9610(55)90777-7. No abstract available.
PMID: 13238699
citation: George Miley Ultraviolet blood irradiation therapy (Knott technic) in acute pyogenic infections. The American Journal of Surgery, Volume 57, Issue 3, September 1942, Pages 493-50
responsible party type: Sponsor
mesh term: Hepatitis C