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A Clinical Trial to Study the Safety and Efficacy of Chandrakanthi Choornam in Patients With Low Sperm Count

Sponsor
Tamil Nadu Dr.M.G.R.Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT02234206
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
20
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Chandrakanthi Choornam (CKC)
 Phase 2

Detailed Description

METHODOLOGY OF PROPOSED RESEARCH:
  1. 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.

  1. Chemical methods of testing

  2. Pharmacological study : A. Spermotogenic Activity

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

  1. CLINICAL STUDY

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

  1. Pilot study B. Main study

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of Chandrakanthi Choornam in Oligospermia - A Preclinical and Clinical Study
Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Apr 1, 2014
Actual Study Completion Date :
Aug 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Chandrakanthi choornam

Chandrakanthi Choornam (CKC) - 12gm in milk OD dose; Oral route 3 Months - duration Intervention Drug: Chandrakanthi Choornam (CKC)

Drug: Chandrakanthi Choornam (CKC)
12gm in milk - OD dose; Oral route; 3 Months ( 90days) - duration Preparation from approved sastric book as per drugs & cosmetic act 1940
Other Names:
  • Nerunjil choornam

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sperm concentration per milliliter of seminal fluid [90 days]

      Changes in the total number of sperm cells per milliliter of seminal fluid were evaluated from baseline to three months

    2. Proportion of Sperm motility [90 days]

      Changes in the percentage of total and progressive motility of sperm were evaluated from baseline to three months

    3. Proportion of Sperm morphology [90 days]

      Changes in the percentage of sperm cells with normal forms were evaluated from baseline to three months

    Secondary Outcome Measures

    1. Impact on the hormonal level due to the clinical trial [90 days]

      Changes in serum Testosterone, LH and FSH were estimated from baseline to three months

    Other Outcome Measures

    1. Assessment on Safety parameters [90 days]

      Safety parameters: Liver function test ,Renal function test , Lipid profile, Haematological profile , Blood Glucose, Urinary parameters were assessed from baseline to three months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • Male infertile Patients with age between 21-45 yrs

    • Marriage history for >1 year

    • Abnormal Sperm count 1-15 million/ml

    • Patients with normal Liver & Renal function test

    • Willing to give specimen of semen before & at the end of the clinical trial

    • Informed patients giving written consent

    Exclusion criteria:

    • Azoospermia - complete absence of sperm cells in the ejaculate

    • Aspermia - complete lack of semen

    • Necrospermia- Spermatozoa in semen are either immobile or dead.

    • Clinical diagnosis of Varicocele & Hydrocele

    • History of Undescended testis

    • Inguinal hernia on physical examination

    • Male accessory gland infection

    • History of DM, Hypertension and Cardiac disease

    • Any recent medical or surgical illness

    • Underwent treatment for promoting Spermatogenic fertility in last 3 months

    • Other Systemic disease requiring specific therapies

    • Known Thyroid disease

    • Past history of Renal, Hepatic or any other chronic illness in the Patient

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National institute of siddha Chennai Tamilnadu India 600047

    Sponsors and Collaborators

    • Tamil Nadu Dr.M.G.R.Medical University

    Investigators

    • Principal Investigator: Dr.B. Akila., M.D (s), National institute of Siddha

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr.B.Akila., M.D (s), Safety and Efficacy of Chandrakanthi Choornam in Oligospermia - A Preclinical and Clinical Study, Tamil Nadu Dr.M.G.R.Medical University
    ClinicalTrials.gov Identifier:
    NCT02234206
    Other Study ID Numbers:
    • Ref.No. ExII(1)/29096/2011
    • CTRI/2014/01/004281
    First Posted:
    Sep 9, 2014
    Last Update Posted:
    Sep 9, 2014
    Last Verified:
    Aug 1, 2014
    Keywords provided by Dr.B.Akila., M.D (s), Safety and Efficacy of Chandrakanthi Choornam in Oligospermia - A Preclinical and Clinical Study, Tamil Nadu Dr.M.G.R.Medical University
    Hypospermatogenesis, Low Sperm Count, Oligozoospermia
    Additional relevant MeSH terms:
    Oligospermia

    Study Results

    No Results Posted as of Sep 9, 2014