A Clinical Trial to Study the Safety and Efficacy of Chandrakanthi Choornam in Patients With Low Sperm Count
Paraules clau
Resum
Descripció
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
| Darrera verificació: | 07/31/2014 |
| Primer enviat: | 08/26/2014 |
| Inscripció estimada enviada: | 09/03/2014 |
| Publicat per primera vegada: | 09/08/2014 |
| Última actualització enviada: | 09/03/2014 |
| Publicació de l'última actualització: | 09/08/2014 |
| Data d'inici de l'estudi real: | 11/30/2012 |
| Data estimada de finalització primària: | 03/31/2014 |
| Data estimada de finalització de l’estudi: | 07/31/2014 |
Condició o malaltia
Intervenció / tractament
Drug: Chandrakanthi choornam
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| 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 |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 21 Years Per a 21 Years |
| Sexes elegibles per estudiar | Male |
| Accepta voluntaris saludables | Sí |
| Criteris | 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 |
Resultat
Mesures de resultats primaris
1. Sperm concentration per milliliter of seminal fluid [90 days]
2. Proportion of Sperm motility [90 days]
3. Proportion of Sperm morphology [90 days]
Mesures de resultats secundaris
1. Impact on the hormonal level due to the clinical trial [90 days]
Altres mesures de resultats
1. Assessment on Safety parameters [90 days]
