“A Comparative Study to Evaluate the Effect of Yog Basti (LekhanAasthapana Basti and Lahshun Taila Anuvasana Basti) and Shamana Aushadha(Vishwadi Guggulu and Aartava Pravartaka Yoga) in the Management ofPolycystic Ovarian Syndromeâ€
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Regular menstrual cycle with proper ovulation and relief from existing symptoms.
研究概览
简要总结
Research report will be soon published after the completion of trial. 20 patients fulfilling the inclusion and exclusion criteria will be randomly selected from OPD and IPD of Department of Prasuti Tantra evum Stree Roga, RGGPG Ayurvedic College and Hospital, Paprola. Patients will be divided randomly into 2 groups; Group I and Group II each with 10 patients. Group I will be given Yog Basti for 8 days as per schedule for 3 consecutive cycles. Group II will be given Aartava Pravartaka Yoga 500mg BD and Vishwadi Guggulu 1gm BD for 3 consecutive cycles. Result will be assessed on the basis of subjective and objective assessment criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 16.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patient willing to go through trial.
- •Affected individuals presented with two out of three criteria of ASHRM/ESHRE (ROTTERDAM) CRITERIA 2013 given below: i) Oligomenorrhea or anovulation ii) Hyperandrogenism clinical and biochemical iii) Polycystic ovaries on sonographic examination 3) Clinically diagnosed and confirmed patients of PCOS.
排除标准
- •Women of age less than 16 and above 35 years.
- •Patient having systemic disease like hypertension, tuberculosis, renal disease, thyroid disorders associated gynecological disorders (fibroids, polyps or ovarian cyst).
- •Patient having congenital adrenal hyperplasia, androgen secreting tumors.
- •Patient unable to give informed consent.
结局指标
主要结局
Regular menstrual cycle with proper ovulation and relief from existing symptoms.
时间窗: within 3 months from the start of medicine.
次要结局
- Feeling of well being and total relief from existing symptoms(Within 6 months from the start of medicines.)