A Clinical Trial to Study the Safety and Efficacy of Chandrakanthi Choornam in Patients With Low Sperm Count
Keywords
Abstract
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
Dates
| Last Verified: | 07/31/2014 |
| First Submitted: | 08/26/2014 |
| Estimated Enrollment Submitted: | 09/03/2014 |
| First Posted: | 09/08/2014 |
| Last Update Submitted: | 09/03/2014 |
| Last Update Posted: | 09/08/2014 |
| Actual Study Start Date: | 11/30/2012 |
| Estimated Primary Completion Date: | 03/31/2014 |
| Estimated Study Completion Date: | 07/31/2014 |
Condition or disease
Intervention/treatment
Drug: Chandrakanthi choornam
Phase
Arm Groups
| 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 12gm in milk - OD dose; Oral route; 3 Months ( 90days) - duration
Preparation from approved sastric book as per drugs & cosmetic act 1940 |
Eligibility Criteria
| Ages Eligible for Study | 21 Years To 21 Years |
| Sexes Eligible for Study | Male |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Sperm concentration per milliliter of seminal fluid [90 days]
2. Proportion of Sperm motility [90 days]
3. Proportion of Sperm morphology [90 days]
Secondary Outcome Measures
1. Impact on the hormonal level due to the clinical trial [90 days]
Other Outcome Measures
1. Assessment on Safety parameters [90 days]
