CTRI/2021/02/031599尚未招募Phase 3 4
Clinical study to evaluate the efficacy of combination shatapushpa taila matra basti and rajahpravartini vati in comparison to rajahpravartini alone in artava kshaya (PCOS).
Ch Brahm Prakash Ayurved Charak Sansthan1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2021年1月3日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Changes in symptoms of Artava Kshaya
研究概览
简要总结
This study is conducted to compare the efficacy of combination of Shatapushpa Taila Matra Basti and Rajahpravartini Vati in management of Artava Kshaya (PCOS) with Rajahpravartini Vati alone. In GROUP A 17 Patients will be given 2 sittings of Shatapushpa Taila Matra Basti for 8 days, for 2 months (one sitting each month) along with oral Rajahpravartini Vati for 2 months. In GROUP B 17 patients will be given drug Rajahpravartini Vati for 2 months orally. Study will be conducted in CBPACS with outcome in relief in symptoms of Artava kshaya and PCOS. After 90 days follow up of each patient will be taken. This study is expected to improve female reproductive health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patient willing to go through trial.
- •â€¢ Patient prediagnosed with PCOS.
- •â€¢ Patients suffering from at least 2 consecutive cycles with Oligomenorrhoea and/ or anovulation.
- •â€¢ Affected individuals presented with two out of three criteria of ASHRM/ESHRE (ROTTERDAM) CRITERIA 2003
- •Oligo or anovulation
- •Hyperandrogenism clinical or biochemical
- •Polycystic ovaries on sonographic examination.
排除标准
- •Patient diagnosed with chronic systemic illness.
- •â€¢ Patient diagnosed with reproductive system congenital abnormalities.
- •â€¢ Pregnancy and lactation.
结局指标
主要结局
Changes in symptoms of Artava Kshaya
时间窗: 90 days
次要结局
- Changes in symptoms of PCOS.(90 days)
研究者
研究点 (1)
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