Randomized comparative clinical trial to evaluate the efficacy of shatapushpa churna along with shatapushpa taila nasya in artava dushti w.s.r. to poly cystic ovarian syndrome (PCOS)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- To explore the effectiveness of Shatapushpa churna along with Shatpushpa taila nasya in the management
研究概览
简要总结
This study is to evaluate the effect of oral administration Shatapushpa Churna along with Shatapushpa taila nasya and to compare it with the effect of oral contraceptive pills containing Norethisterone and Ethinylestradiol in Artavadusti w. s. r. to Poly Cystic Ovarian Syndrome. it is a randomized, open-labeled, comparative clinical trial conducted for 90 days with a follow-up of 30 days. It includes 94 female patients aged 18 to 40 years diagnosed with PCOS based on Rotterdam criteria. Participants are divided into two groups — one receiving Shatapushpa Churna with Shatapushpa Taila Nasya and the other receiving oral contraceptive pills containing Norethisterone and Ethinylestradiol. The main objective is to assess improvement and possible cure of PCOS and related menstrual irregularities (Artava Dushti). Secondary observations include changes in acne, hirsutism, hormone levels (LH, FSH, and testosterone), and ovarian size on ultrasonography. Assessment will be done through menstrual history, acne and hirsutism scoring, hormonal evaluation, and pelvic USG. The study aims to compare the efficacy of Ayurvedic treatment with standard hormonal therapy in managing PCOS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •If Patient willing to give informed consent to be included.
- •Female patient of age group between
- •40 years (both married and unmarried).
- •ASRM or ESHRM (Rotterdam) criteria Affected patient must follow two out of three criteria (1) Anovulation, (2) Hyperandrogenism (clinical/biochemical), (3) Polycystic Ovaries (confirmed by USG).
排除标准
- •• Patient who is not willing to give voluntary informed consent.
- •• Women of age less than 18 years and more than 40 years.
- •• Patient with chronic systemic illness (cardiac failure, hypertension, diabetes mellitus, tuberculosis, chronic renal disease).
- •• Patient with carcinoma of reproductive organs.
结局指标
主要结局
To explore the effectiveness of Shatapushpa churna along with Shatpushpa taila nasya in the management
时间窗: 90 days
of Artava Dushti w.s.r to Polycystic ovarian syndrome (PCOS) and compare with modern medicine.
时间窗: 90 days
次要结局
- 1. To determine the efficacy of the interventions on LH, FSH levels in the management of polycystic(ovarian syndrome (PCOS).)
研究者
Dr Narendra Kumar Meena
Post Graduate Institute of Ayurveda PGIA Jodhpur Rajathan India 342037