<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/NCT04493476</url>
  </required_header>
  <id_info>
    <org_study_id>0206-19COM2</org_study_id>
    <nct_id>NCT04493476</nct_id>
  </id_info>
  <brief_title>Using a Herbal Remedy Extract for the Treatment of Endometriosis Symptoms</brief_title>
  <official_title>Using a Herbal Remedy Extract for the Treatment of Endometriosis Symptoms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carmel Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Carmel Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective, double-blind, placebo-controlled trial examining the effect of Chinese herbal&#xD;
      medicine combined with curcumin defined as a dietary supplement on a study group of women&#xD;
      with endometriosis, compared to control group.&#xD;
&#xD;
      research product:Chinese herbal extract and curcumin extract, which appear as nutritional&#xD;
      supplements in the Ministry of Health database, the research product is packed in 800mg&#xD;
      capsules.&#xD;
&#xD;
      Intended use: Composition of 14 different nutritional supplements, in Chinese herbal formula,&#xD;
      for the treatment of endometriosis and its symptoms. The formula is formulated according to&#xD;
      Chinese medicine principles and aims to reduce inflammation of the pelvic organs and reduce&#xD;
      the levels of pain caused by endometriosis disease.&#xD;
&#xD;
      Objectives:Examine the Effect of Using Nutritional Supplements on Symptoms in Patients with&#xD;
      Targeted Endometriosis Symptoms.&#xD;
&#xD;
      Primary Endpoints:&#xD;
&#xD;
      Benefit of pain in women suffering from symptoms of endometriosis patients taking herbal&#xD;
      extract for 4 months of treatment.&#xD;
&#xD;
      Structure of the study:A prospective, double-blind, double-blind, placebo-controlled&#xD;
      (randomized) placebo-controlled trial involving women suffering from endometriosis symptoms&#xD;
      and meeting the inclusion and exclusion criteria and who agreed to participate in the study.&#xD;
      The women will be randomly divided into the following two arms:&#xD;
&#xD;
        1. Study Group - Taking a daily dose of dietary supplement extract capsules&#xD;
&#xD;
        2. Control group - take a daily dose of Invo capsules Treatment efficacy will be measured&#xD;
           according to a dedicated patient questionnaire with endometriosis symptoms that assess&#xD;
           quality of life measures.&#xD;
&#xD;
      The study population will include 60 symptomatic women treated at the Multidisciplinary&#xD;
      Center for Endometriosis Therapy at Lynn Medical Center.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endometriosis is a chronic and progressive gynecological disease, with an estimated invention&#xD;
      of between 8-10% of women of childbearing age in the Western world . The disease is&#xD;
      characterized by the presence of tissue resembling endometrial tissue . The tissue cells that&#xD;
      are in the uterine space can settle on different organs in the pelvis. The cells continue to&#xD;
      respond to the hormonal cycle as if they were inside the uterus and in each menstrual can&#xD;
      grow and bleed. At the same time, an inflammatory process can be associated with various&#xD;
      symptoms of pain. Symptoms are not specific but usually cyclical according to menstrual&#xD;
      timing and include: severe menstrual cramps, heavy bleeding, diarrhea and constipation,&#xD;
      infertility, urinary pain, recurrent infections, fainting, intercourse pain, leg pain and&#xD;
      more.&#xD;
&#xD;
      The current practice is based on the removal of endometriosis lesions in surgery and / or&#xD;
      drug therapy designed to suppress existing lesion activity and prevent lesion recurrence&#xD;
      after surgery. To diagnose endometriosis in a definite way it is necessary to visually&#xD;
      identify the lesions and by biopsy in surgery. In many patients, the symptoms of&#xD;
      endometriosis can be treated pharmacologically and without surgery . Therefore, it is now&#xD;
      widely accepted in many cases to treat pharmacologic anatomy empirically based on an&#xD;
      estimated endometriosis-based diagnosis of appropriate anemia, gynecological examination, and&#xD;
      vaginal ultrasound.&#xD;
&#xD;
      Very little has been investigated regarding the integration of endometriosis phenomena&#xD;
      through complementary medicine that includes herbs and acupuncture, despite the vast clinical&#xD;
      knowledge and experience gained. In the present study, we would like to examine the effect of&#xD;
      complementary medicine that would include a combination of herbal remedies for pain symptoms&#xD;
      in women with endometriosis.&#xD;
&#xD;
      In recent years, the Western world has begun to integrate complementary medicine in various&#xD;
      treatments for chronic diseases and in particular endometriosis . The Chinese language review&#xD;
      included 13 Chinese randomized clinical trials from 1994 to 2000. The studies included 1076&#xD;
      women who received Chinese herbs alone or in combination with recognized drugs . The proposed&#xD;
      mechanism is that the herbs are involved in regulation of the endocrine and immune system and&#xD;
      which improve blood flow and anti-inflammatory activity .&#xD;
&#xD;
      The ability of Chinese herbs to affect physiological changes indicates a mechanism of&#xD;
      biological action of the herbs. However, the medicinal plants appear to have lower potency&#xD;
      activity than synthetic drugs. They can contain an anti-inflammatory but less active&#xD;
      ingredient than synthetic steroids.&#xD;
&#xD;
      Research Rationale Endometriosis is a chronic disease of infertile women. The main treatment&#xD;
      is based on hormone drug therapy and surgical treatment. There are patients who, despite&#xD;
      these treatments, still suffer from symptoms of endometriosis. There are also patients who&#xD;
      are medically balanced but have to stop treatment for various reasons and need another&#xD;
      non-hormonal response. Herbs have been found effective in treating gynecological problems and&#xD;
      especially in chronic pelvic pain. They may relieve the symptoms in those women who wish to&#xD;
      avoid hormone or surgical treatment or who are not symptomatically balanced despite the usual&#xD;
      treatments.&#xD;
&#xD;
      The purpose of the study Investigate the effectiveness of treatment of symptoms and quality&#xD;
      of life measures by the use of medicinal plants in women with symptoms of endometriosis.&#xD;
&#xD;
      Preliminary Results Primary Endpoints Benefit of pain indices in women suffering from&#xD;
      symptoms of endometriosis between patients taking herbal extract and patients taking Invo for&#xD;
      4 months of treatment. Benefit is defined as a statistically significant improvement in VAS&#xD;
      dimensions that will be examined by a daily journal and medical questionnaire.&#xD;
&#xD;
      Secondary Results Secondary Endpoints Quality-Of-Life Benefit Defined as a statistically&#xD;
      significant improvement in questionnaire indices.&#xD;
&#xD;
      Also, a reduction in the use of painkillers and a lack of working days each month between the&#xD;
      two groups.&#xD;
&#xD;
      The research product:Chinese herbal extract and curcumin extract, which appear as nutritional&#xD;
      supplements in the Ministry of Health database, the research product is packed in 800mg&#xD;
      capsules.&#xD;
&#xD;
      Intended use: Composition of 14 different nutritional supplements, in Chinese herbal formula,&#xD;
      for the treatment of endometriosis and its symptoms. The formula is formulated according to&#xD;
      Chinese medicine principles and aims to reduce inflammation of the pelvic organs and reduce&#xD;
      the levels of pain caused by endometriosis disease.&#xD;
&#xD;
      Objectives:Examine the Effect of Using Nutritional Supplements on Symptoms in Patients with&#xD;
      Targeted Endometriosis Symptoms.&#xD;
&#xD;
      Primary Endpoints:&#xD;
&#xD;
      Benefit of pain indices in women suffering from symptoms of endometriosis between patients&#xD;
      taking herbal extract and patients taking Invo for 4 months of treatment.&#xD;
&#xD;
      Structure of the study:A prospective, double-blind, double-blind, placebo-controlled&#xD;
      (randomized) placebo-controlled trial involving women suffering from endometriosis symptoms&#xD;
      and meeting the inclusion and exclusion criteria and who agreed to participate in the study.&#xD;
      The women will be randomly divided into the following two arms:&#xD;
&#xD;
        1. Study Group - Taking a daily dose of dietary supplement extract capsules&#xD;
&#xD;
        2. Control group - take a daily dose of Invo capsules Treatment efficacy will be measured&#xD;
           according to a dedicated patient questionnaire with endometriosis symptoms that assess&#xD;
           quality of life measures.&#xD;
&#xD;
      The study population will include 60 symptomatic women treated at the Multidisciplinary&#xD;
      Center for Endometriosis Therapy at Lynn Medical Center.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2022</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>This is a prospective, placebo-controlled, double-blind randomized trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in visual analogue scale pain scores in women with endometriosis symptoms treated with the herbal extract formula</measure>
    <time_frame>6 months</time_frame>
    <description>Improvement will be measured by statistically significant visual analogue scale score differences collected by daily patient questionnaires</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in quality of life followiing treatment with the herbal extract formula</measure>
    <time_frame>6 months</time_frame>
    <description>Statistically significant changes in QOL questionnaire scores and decrease in use of analgesics</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Endometriosis</condition>
  <arm_group>
    <arm_group_label>Chineese Herbal formula</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The study group will be given capsules containing Chinese herbal formula extract - Traditional Chinese MedicinalSubstances</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The control group tested will receive placebo capsules. Containing starch.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chinese herbal formula</intervention_name>
    <description>Chinese herbal formula</description>
    <arm_group_label>Chineese Herbal formula</arm_group_label>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women with surgically diagnosed endometriosis and / or a clinical picture suitable for&#xD;
             endometriosis.&#xD;
&#xD;
          2. Age 18 to 45. The patient is capable and willing to agree in writing ICF to enter the&#xD;
             study.&#xD;
&#xD;
          3. There is no known allergy to any of the ingredients in the plant formula according to&#xD;
             a sensitive patient's questioning.&#xD;
&#xD;
          4. The patient agrees to use contraception during the study period until the end of the&#xD;
             medication if hormone therapy is not taken.&#xD;
&#xD;
          5. The patient has not changed / stopped / started hormone therapy in the previous three&#xD;
             months of recruitment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Treated with kidney or liver disease, severe cardiovascular disease, chronic pancreatitis,&#xD;
        diabetes or gallstones.&#xD;
&#xD;
        2. Treated with another cause of pain known. 3. Treated during pregnancy or breastfeeding.&#xD;
        4. A patient who is unable or unwilling to agree in writing for inclusion in the study.&#xD;
&#xD;
        5. Allergy is known to be one of the ingredients in the plant formula. 6. A patient who&#xD;
        started hormone therapy, changed hormone therapy, or stopped in the three months prior to&#xD;
        recruiting for the study.&#xD;
&#xD;
        7. Women who do not speak the Hebrew language about her ignorance&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yuval Kaufman, Dr</last_name>
    <phone>972-4-9551028</phone>
    <email>mdykaufman@clalit.org.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>hila kfir</last_name>
    <phone>972-523313350</phone>
    <email>hila_kf@clalit.org.il</email>
  </overall_contact_backup>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Carmel Medical Center</investigator_affiliation>
    <investigator_full_name>Yuval Kauffman</investigator_full_name>
    <investigator_title>Dr yuval kaufman. Senior surgeon in the Department of Obstetrics and Gynecology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04493476
org study id: 0206-19COM2
nct id: NCT04493476
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A prospective, double-blind, placebo-controlled trial examining the effect of Chinese herbal
      medicine combined with curcumin defined as a dietary supplement on a study group of women
      with endometriosis, compared to control group.

      research product:Chinese herbal extract and curcumin extract, which appear as nutritional
      supplements in the Ministry of Health database, the research product is packed in 800mg
      capsules.

      Intended use: Composition of 14 different nutritional supplements, in Chinese herbal formula,
      for the treatment of endometriosis and its symptoms. The formula is formulated according to
      Chinese medicine principles and aims to reduce inflammation of the pelvic organs and reduce
      the levels of pain caused by endometriosis disease.

      Objectives:Examine the Effect of Using Nutritional Supplements on Symptoms in Patients with
      Targeted Endometriosis Symptoms.

      Primary Endpoints:

      Benefit of pain in women suffering from symptoms of endometriosis patients taking herbal
      extract for 4 months of treatment.

      Structure of the study:A prospective, double-blind, double-blind, placebo-controlled
      (randomized) placebo-controlled trial involving women suffering from endometriosis symptoms
      and meeting the inclusion and exclusion criteria and who agreed to participate in the study.
      The women will be randomly divided into the following two arms:

        1. Study Group - Taking a daily dose of dietary supplement extract capsules

        2. Control group - take a daily dose of Invo capsules Treatment efficacy will be measured
           according to a dedicated patient questionnaire with endometriosis symptoms that assess
           quality of life measures.

      The study population will include 60 symptomatic women treated at the Multidisciplinary
      Center for Endometriosis Therapy at Lynn Medical Center.
Endometriosis is a chronic and progressive gynecological disease, with an estimated invention
      of between 8-10% of women of childbearing age in the Western world . The disease is
      characterized by the presence of tissue resembling endometrial tissue . The tissue cells that
      are in the uterine space can settle on different organs in the pelvis. The cells continue to
      respond to the hormonal cycle as if they were inside the uterus and in each menstrual can
      grow and bleed. At the same time, an inflammatory process can be associated with various
      symptoms of pain. Symptoms are not specific but usually cyclical according to menstrual
      timing and include: severe menstrual cramps, heavy bleeding, diarrhea and constipation,
      infertility, urinary pain, recurrent infections, fainting, intercourse pain, leg pain and
      more.

      The current practice is based on the removal of endometriosis lesions in surgery and / or
      drug therapy designed to suppress existing lesion activity and prevent lesion recurrence
      after surgery. To diagnose endometriosis in a definite way it is necessary to visually
      identify the lesions and by biopsy in surgery. In many patients, the symptoms of
      endometriosis can be treated pharmacologically and without surgery . Therefore, it is now
      widely accepted in many cases to treat pharmacologic anatomy empirically based on an
      estimated endometriosis-based diagnosis of appropriate anemia, gynecological examination, and
      vaginal ultrasound.

      Very little has been investigated regarding the integration of endometriosis phenomena
      through complementary medicine that includes herbs and acupuncture, despite the vast clinical
      knowledge and experience gained. In the present study, we would like to examine the effect of
      complementary medicine that would include a combination of herbal remedies for pain symptoms
      in women with endometriosis.

      In recent years, the Western world has begun to integrate complementary medicine in various
      treatments for chronic diseases and in particular endometriosis . The Chinese language review
      included 13 Chinese randomized clinical trials from 1994 to 2000. The studies included 1076
      women who received Chinese herbs alone or in combination with recognized drugs . The proposed
      mechanism is that the herbs are involved in regulation of the endocrine and immune system and
      which improve blood flow and anti-inflammatory activity .

      The ability of Chinese herbs to affect physiological changes indicates a mechanism of
      biological action of the herbs. However, the medicinal plants appear to have lower potency
      activity than synthetic drugs. They can contain an anti-inflammatory but less active
      ingredient than synthetic steroids.

      Research Rationale Endometriosis is a chronic disease of infertile women. The main treatment
      is based on hormone drug therapy and surgical treatment. There are patients who, despite
      these treatments, still suffer from symptoms of endometriosis. There are also patients who
      are medically balanced but have to stop treatment for various reasons and need another
      non-hormonal response. Herbs have been found effective in treating gynecological problems and
      especially in chronic pelvic pain. They may relieve the symptoms in those women who wish to
      avoid hormone or surgical treatment or who are not symptomatically balanced despite the usual
      treatments.

      The purpose of the study Investigate the effectiveness of treatment of symptoms and quality
      of life measures by the use of medicinal plants in women with symptoms of endometriosis.

      Preliminary Results Primary Endpoints Benefit of pain indices in women suffering from
      symptoms of endometriosis between patients taking herbal extract and patients taking Invo for
      4 months of treatment. Benefit is defined as a statistically significant improvement in VAS
      dimensions that will be examined by a daily journal and medical questionnaire.

      Secondary Results Secondary Endpoints Quality-Of-Life Benefit Defined as a statistically
      significant improvement in questionnaire indices.

      Also, a reduction in the use of painkillers and a lack of working days each month between the
      two groups.

      The research product:Chinese herbal extract and curcumin extract, which appear as nutritional
      supplements in the Ministry of Health database, the research product is packed in 800mg
      capsules.

      Intended use: Composition of 14 different nutritional supplements, in Chinese herbal formula,
      for the treatment of endometriosis and its symptoms. The formula is formulated according to
      Chinese medicine principles and aims to reduce inflammation of the pelvic organs and reduce
      the levels of pain caused by endometriosis disease.

      Objectives:Examine the Effect of Using Nutritional Supplements on Symptoms in Patients with
      Targeted Endometriosis Symptoms.

      Primary Endpoints:

      Benefit of pain indices in women suffering from symptoms of endometriosis between patients
      taking herbal extract and patients taking Invo for 4 months of treatment.

      Structure of the study:A prospective, double-blind, double-blind, placebo-controlled
      (randomized) placebo-controlled trial involving women suffering from endometriosis symptoms
      and meeting the inclusion and exclusion criteria and who agreed to participate in the study.
      The women will be randomly divided into the following two arms:

        1. Study Group - Taking a daily dose of dietary supplement extract capsules

        2. Control group - take a daily dose of Invo capsules Treatment efficacy will be measured
           according to a dedicated patient questionnaire with endometriosis symptoms that assess
           quality of life measures.

      The study population will include 60 symptomatic women treated at the Multidisciplinary
      Center for Endometriosis Therapy at Lynn Medical Center.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a prospective, placebo-controlled, double-blind randomized trial
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Improvement in visual analogue scale pain scores in women with endometriosis symptoms treated with the herbal extract formula
time frame: 6 months
description: Improvement will be measured by statistically significant visual analogue scale score differences collected by daily patient questionnaires
measure: Improvement in quality of life followiing treatment with the herbal extract formula
time frame: 6 months
description: Statistically significant changes in QOL questionnaire scores and decrease in use of analgesics
arm group label: Chineese Herbal formula
arm group type: Active Comparator
description: The study group will be given capsules containing Chinese herbal formula extract - Traditional Chinese MedicinalSubstances
arm group label: placebo
arm group type: Placebo Comparator
description: The control group tested will receive placebo capsules. Containing starch.
intervention type: Drug
intervention name: Chinese herbal formula
description: Chinese herbal formula
arm group label: Chineese Herbal formula
arm group label: placebo
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Yuval Kaufman, Dr
phone: 972-4-9551028
email: mdykaufman@clalit.org.il
last name: hila kfir
phone: 972-523313350
email: hila_kf@clalit.org.il
responsible party type: Principal Investigator
investigator affiliation: Carmel Medical Center
investigator full name: Yuval Kauffman
investigator title: Dr yuval kaufman. Senior surgeon in the Department of Obstetrics and Gynecology
mesh term: Endometriosis
sharing ipd: Undecided