A Clinical Trial to Study the Safety and Efficacy of Chandrakanthi Choornam in Patients With Low Sperm Count
Ключови думи
Резюме
Описание
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
Дати
| Последна проверка: | 07/31/2014 |
| Първо изпратено: | 08/26/2014 |
| Очаквано записване подадено: | 09/03/2014 |
| Първо публикувано: | 09/08/2014 |
| Изпратена последна актуализация: | 09/03/2014 |
| Последна актуализация публикувана: | 09/08/2014 |
| Действителна начална дата на проучването: | 11/30/2012 |
| Приблизителна дата на първично завършване: | 03/31/2014 |
| Очаквана дата на завършване на проучването: | 07/31/2014 |
Състояние или заболяване
Интервенция / лечение
Drug: Chandrakanthi choornam
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| 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 |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 21 Years Да се 21 Years |
| Полове, допустими за проучване | Male |
| Приема здрави доброволци | Да |
| Критерии | 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 |
Резултат
Първични изходни мерки
1. Sperm concentration per milliliter of seminal fluid [90 days]
2. Proportion of Sperm motility [90 days]
3. Proportion of Sperm morphology [90 days]
Вторични изходни мерки
1. Impact on the hormonal level due to the clinical trial [90 days]
Други изходни мерки
1. Assessment on Safety parameters [90 days]
