<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/NCT02234206</url>
  </required_header>
  <id_info>
    <org_study_id>Ref.No. ExII(1)/29096/2011</org_study_id>
    <secondary_id>CTRI/2014/01/004281</secondary_id>
    <nct_id>NCT02234206</nct_id>
  </id_info>
  <brief_title>A Clinical Trial to Study the Safety and Efficacy of Chandrakanthi Choornam in Patients With Low Sperm Count</brief_title>
  <official_title>Safety and Efficacy of Chandrakanthi Choornam in Oligospermia - A Preclinical and Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tamil Nadu Dr.M.G.R.Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tamil Nadu Dr.M.G.R.Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an Open clinical trial to study the safety and efficacy of Chandrakanthi Choornam in&#xD;
      40 patients with Oligospermia. Chandrakanthi choornam is a formulation consisting of 25&#xD;
      ingredients. They are Curculigo orchioides -rhizome, Madhuca longifolia - flower, Cinnamomum&#xD;
      verum -bark,Cinnamomum tamala-Leaf, Syzygium aromaticum - flower bud,Coscinium&#xD;
      fenestratum-stem bark,Mesua ferrea-flower, Maerua arenaria-tuber, Adhatoda vasica- seed,&#xD;
      Moringa oleifera-seed, Lawsonia inermis-seed, Vitis vinifera- fruit, Bombax ceiba- gum,&#xD;
      Bambusa aurundinaceae-salt,Phoenix dactilifera- fruit,Ilicium verum- flower, Mucuna&#xD;
      prurita-seed, Cyperus rotundus- rhizome, Glycyrrhiza glabra-root, Tribulus terrestris-fruit,&#xD;
      Cuminum cyminum-seed,Costus speciosus-root,Myrsitica fragrans-seed, Alternanthera&#xD;
      sessilis-seed and asphaltum-mineral. Treatment duration is three months.Study is conducted in&#xD;
      India (Chennai). Primary outcome measure is to see the changes in sperm count, motility and&#xD;
      morphology. Secondary Outcome measure is to see the impact on the harmone level.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      METHODOLOGY OF PROPOSED RESEARCH:&#xD;
&#xD;
      I. Preclinical study II. Clinical study&#xD;
&#xD;
      I. PRECLINICAL STUDY:&#xD;
&#xD;
      Standardization Of The Study Drug&#xD;
&#xD;
        1. Botanical Identification&#xD;
&#xD;
        2. Chemical Identification&#xD;
&#xD;
        3. Preparation of the study drugs:&#xD;
&#xD;
           Formulation: Chandrakanthi choornam Source : Chikicharathna deepam Part II. Pg-168&#xD;
           (Approved sastric book as per drugs &amp; cosmetic act 1940.&#xD;
&#xD;
        4. Chemical methods of testing&#xD;
&#xD;
        5. Pharmacological study : A. Spermotogenic Activity&#xD;
&#xD;
        6. Toxicological study : A. Acute Toxicity B. Long term Toxicity&#xD;
&#xD;
      II. CLINICAL STUDY&#xD;
&#xD;
      Conducted as per the guidelines of GCP accepted by Ayush adapted from the ICH.&#xD;
&#xD;
      A. Pilot study B. Main study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sperm concentration per milliliter of seminal fluid</measure>
    <time_frame>90 days</time_frame>
    <description>Changes in the total number of sperm cells per milliliter of seminal fluid were evaluated from baseline to three months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of Sperm motility</measure>
    <time_frame>90 days</time_frame>
    <description>Changes in the percentage of total and progressive motility of sperm were evaluated from baseline to three months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of Sperm morphology</measure>
    <time_frame>90 days</time_frame>
    <description>Changes in the percentage of sperm cells with normal forms were evaluated from baseline to three months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact on the hormonal level due to the clinical trial</measure>
    <time_frame>90 days</time_frame>
    <description>Changes in serum Testosterone, LH and FSH were estimated from baseline to three months</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Assessment on Safety parameters</measure>
    <time_frame>90 days</time_frame>
    <description>Safety parameters: Liver function test ,Renal function test , Lipid profile, Haematological profile , Blood Glucose, Urinary parameters were assessed from baseline to three months</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Oligospermia</condition>
  <arm_group>
    <arm_group_label>Chandrakanthi choornam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chandrakanthi Choornam (CKC) - 12gm in milk&#xD;
OD dose; Oral route&#xD;
3 Months - duration&#xD;
Intervention Drug: Chandrakanthi Choornam (CKC)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chandrakanthi Choornam (CKC)</intervention_name>
    <description>12gm in milk - OD dose; Oral route; 3 Months ( 90days) - duration&#xD;
Preparation from approved sastric book as per drugs &amp; cosmetic act 1940</description>
    <arm_group_label>Chandrakanthi choornam</arm_group_label>
    <other_name>Nerunjil choornam</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Male infertile Patients with age between 21-45 yrs&#xD;
&#xD;
          -  Marriage history for &gt;1 year&#xD;
&#xD;
          -  Abnormal Sperm count 1-15 million/ml&#xD;
&#xD;
          -  Patients with normal Liver &amp; Renal function test&#xD;
&#xD;
          -  Willing to give specimen of semen before &amp; at the end of the clinical trial&#xD;
&#xD;
          -  Informed patients giving written consent&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Azoospermia - complete absence of sperm cells in the ejaculate&#xD;
&#xD;
          -  Aspermia - complete lack of semen&#xD;
&#xD;
          -  Necrospermia- Spermatozoa in semen are either immobile or dead.&#xD;
&#xD;
          -  Clinical diagnosis of Varicocele &amp; Hydrocele&#xD;
&#xD;
          -  History of Undescended testis&#xD;
&#xD;
          -  Inguinal hernia on physical examination&#xD;
&#xD;
          -  Male accessory gland infection&#xD;
&#xD;
          -  History of DM, Hypertension and Cardiac disease&#xD;
&#xD;
          -  Any recent medical or surgical illness&#xD;
&#xD;
          -  Underwent treatment for promoting Spermatogenic fertility in last 3 months&#xD;
&#xD;
          -  Other Systemic disease requiring specific therapies&#xD;
&#xD;
          -  Known Thyroid disease&#xD;
&#xD;
          -  Past history of Renal, Hepatic or any other chronic illness in the Patient&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr.B. Akila., M.D (s)</last_name>
    <role>Principal Investigator</role>
    <affiliation>National institute of Siddha</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National institute of siddha</name>
      <address>
        <city>Chennai</city>
        <state>Tamilnadu</state>
        <zip>600047</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>September 4, 2014</last_update_submitted>
  <last_update_submitted_qc>September 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tamil Nadu Dr.M.G.R.Medical University</investigator_affiliation>
    <investigator_full_name>Dr.B.Akila., M.D (s)</investigator_full_name>
    <investigator_title>Safety and Efficacy of Chandrakanthi Choornam in Oligospermia - A Preclinical and Clinical Study</investigator_title>
  </responsible_party>
  <keyword>Hypospermatogenesis, Low Sperm Count, Oligozoospermia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oligospermia</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/NCT02234206
org study id: Ref.No. ExII(1)/29096/2011
secondary id: CTRI/2014/01/004281
nct id: NCT02234206
lead sponsor: 
has dmc: No
This is an Open clinical trial to study the safety and efficacy of Chandrakanthi Choornam in
      40 patients with Oligospermia. Chandrakanthi choornam is a formulation consisting of 25
      ingredients. They are Curculigo orchioides -rhizome, Madhuca longifolia - flower, Cinnamomum
      verum -bark,Cinnamomum tamala-Leaf, Syzygium aromaticum - flower bud,Coscinium
      fenestratum-stem bark,Mesua ferrea-flower, Maerua arenaria-tuber, Adhatoda vasica- seed,
      Moringa oleifera-seed, Lawsonia inermis-seed, Vitis vinifera- fruit, Bombax ceiba- gum,
      Bambusa aurundinaceae-salt,Phoenix dactilifera- fruit,Ilicium verum- flower, Mucuna
      prurita-seed, Cyperus rotundus- rhizome, Glycyrrhiza glabra-root, Tribulus terrestris-fruit,
      Cuminum cyminum-seed,Costus speciosus-root,Myrsitica fragrans-seed, Alternanthera
      sessilis-seed and asphaltum-mineral. Treatment duration is three months.Study is conducted in
      India (Chennai). Primary outcome measure is to see the changes in sperm count, motility and
      morphology. Secondary Outcome measure is to see the impact on the harmone level.
METHODOLOGY OF PROPOSED RESEARCH:

      I. Preclinical study II. Clinical study

      I. PRECLINICAL STUDY:

      Standardization Of The Study Drug

        1. Botanical Identification

        2. Chemical Identification

        3. Preparation of the study drugs:

           Formulation: Chandrakanthi choornam Source : Chikicharathna deepam Part II. Pg-168
           (Approved sastric book as per drugs & cosmetic act 1940.

        4. Chemical methods of testing

        5. Pharmacological study : A. Spermotogenic Activity

        6. Toxicological study : A. Acute Toxicity B. Long term Toxicity

      II. CLINICAL STUDY

      Conducted as per the guidelines of GCP accepted by Ayush adapted from the ICH.

      A. Pilot study B. Main study
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Sperm concentration per milliliter of seminal fluid
time frame: 90 days
description: Changes in the total number of sperm cells per milliliter of seminal fluid were evaluated from baseline to three months
measure: Proportion of Sperm motility
time frame: 90 days
description: Changes in the percentage of total and progressive motility of sperm were evaluated from baseline to three months
measure: Proportion of Sperm morphology
time frame: 90 days
description: Changes in the percentage of sperm cells with normal forms were evaluated from baseline to three months
measure: Impact on the hormonal level due to the clinical trial
time frame: 90 days
description: Changes in serum Testosterone, LH and FSH were estimated from baseline to three months
measure: Assessment on Safety parameters
time frame: 90 days
description: Safety parameters: Liver function test ,Renal function test , Lipid profile, Haematological profile , Blood Glucose, Urinary parameters were assessed from baseline to three months
arm group label: Chandrakanthi choornam
arm group type: Experimental
description: Chandrakanthi Choornam (CKC) - 12gm in milk
OD dose; Oral route
3 Months - duration
Intervention Drug: Chandrakanthi Choornam (CKC)
intervention type: Drug
intervention name: Chandrakanthi Choornam (CKC)
description: 12gm in milk - OD dose; Oral route; 3 Months ( 90days) - duration
Preparation from approved sastric book as per drugs & cosmetic act 1940
arm group label: Chandrakanthi choornam
other name: Nerunjil choornam
criteria: 
gender: Male
minimum age: 21 Years
maximum age: 45 Years
healthy volunteers: No
last name: Dr.B. Akila., M.D (s)
role: Principal Investigator
affiliation: National institute of Siddha
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Tamil Nadu Dr.M.G.R.Medical University
investigator full name: Dr.B.Akila., M.D (s)
investigator title: Safety and Efficacy of Chandrakanthi Choornam in Oligospermia - A Preclinical and Clinical Study
mesh term: Oligospermia