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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Safety and Efficacy of Chandrakanthi Choornam in Oligospermia - A Preclinical and Clinical Study

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.

Detailed Summary:

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


Sponsor: Tamil Nadu Dr.M.G.R.Medical University

Current Primary Outcome:

  • Sperm concentration per milliliter of seminal fluid [ Time Frame: 90 days ]
    Changes in the total number of sperm cells per milliliter of seminal fluid were evaluated from baseline to three months
  • Proportion of Sperm motility [ Time Frame: 90 days ]
    Changes in the percentage of total and progressive motility of sperm were evaluated from baseline to three months
  • Proportion of Sperm morphology [ Time Frame: 90 days ]
    Changes in the percentage of sperm cells with normal forms were evaluated from baseline to three months


Original Primary Outcome: Same as current

Current Secondary Outcome: Impact on the hormonal level due to the clinical trial [ Time Frame: 90 days ]

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


Original Secondary Outcome: Same as current

Information By: Tamil Nadu Dr.M.G.R.Medical University

Dates:
Date Received: August 27, 2014
Date Started: December 2012
Date Completion:
Last Updated: September 4, 2014
Last Verified: August 2014