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

Phase 2

Completed

• Conditions: Oligospermia
• Interventions: Drug: Chandrakanthi Choornam (CKC)

• Registration Number: NCT02234206
• Lead Sponsor: Tamil Nadu Dr.M.G.R.Medical University

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 Description

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

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2014-04
• Status Verified: 2014-08
• Study Completion: 2014-08
• Study First Submitted: 2014-08-27
• Study First Submitted QC: 2014-09-04
• Last Update Submitted: 2014-09-04
• Study First Posted: 2014-09-09
• Last Update Posted: 2014-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Proportion of Sperm motility	90 days	Changes in the percentage of total and progressive motility of sperm were evaluated from baseline to three months
Proportion of Sperm morphology	90 days	Changes in the percentage of sperm cells with normal forms were evaluated from baseline to three months
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National institute of siddha; 🇮🇳 Chennai, Tamilnadu, India