A Randomized Open-Labelled Controlled Clinical Study To Evaluate The Efficacy Of Ashwagandha, Gokshura and Daruharidra Churna orally in Artava Kshaya with special reference to LH: FSH ratio and Insulin Resistance in Polycystic Ovarian Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- •To evaluate the efficacy of Ashwagandha, Gokshura and Daruharidra Churna orally in Artava Kshaya with special reference to LH: FSH ratio and Insulin Resistance in Polycystic Ovarian Syndrome.
研究概览
简要总结
This randomized, open-labelled controlled clinical study is designed to evaluate the efficacy of a polyherbal formulation comprising Ashwagandha (Withania somnifera), Gokshura (Tribulus terrestris), and Daruharidra (Berberis aristata) Churna administered orally in patients diagnosed with Artava Kshaya, with special reference to LH:FSH ratio and insulin resistance in Polycystic Ovarian Syndrome (PCOS).
Artava Kshaya, as described in Ayurveda, is characterized by menstrual irregularities, scanty bleeding, and associated symptoms, which closely resemble the clinical manifestations of PCOS. The selected herbs have documented actions in Ayurveda and modern research, including hormonal modulation, anti-inflammatory effects, and insulin-sensitizing properties.
A total of 112 female participants (aged 18–35 years) fulfilling Rotterdam criteria for PCOS and Ayurvedic signs of Artava Kshaya will be randomized into two groups:
- Group A (Trial Group): Will receive 3g of Ashwagandha, Gokshura, and Daruharidra Churna orally, twice daily on an empty stomach for 3 menstrual cycles.
- Group B (Control Group): Will receive 250 mg of Metformin Hydrochloride twice daily after food for 3 menstrual cycles.
Both groups will follow a standardized low-calorie diet and daily exercise regimen. Efficacy will be assessed based on changes in LH:FSH ratio, fasting glucose/insulin ratio , menstrual patterns, anthropometric indices (BMI, WHR), and USG-based ovarian morphology. Subjective symptoms and signs rooted in Ayurvedic diagnostics will also be tracked using predefined grading scales.
This study aims to bridge a significant knowledge gap by evaluating a safe, cost-effective, and holistic Ayurvedic alternative to conventional therapy for PCOS and Artava Kshaya, while contributing to evidence-based integration of traditional medicine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •a.Patients between the age group of 18 years to 35 years, irrespective of marital status.
- •b.Patients fulfilling Rotterdam criteria.
- •c.Patients presenting with any of the classical features of Artava Kshaya, Nashtarthava, Pushpaghni, Vikuta Jataharini.
- •d.Patients willing to sign consent form.
排除标准
- •a.Patients with Primary Amenorrhea.
- •b.Patients with known case of Premature Ovarian Failure.
- •c.Patients using of Oral Contraceptives (current or within the last 3 months).
- •d.Patients with Known case of Malignancies and Chronic Systemic Diseases and Psychiatric disorders.
- •e.Patients with Known case of Adrenal Hyperplasia, AndrogenSecreting Neoplasm, Cushing Syndrome.
结局指标
主要结局
•To evaluate the efficacy of Ashwagandha, Gokshura and Daruharidra Churna orally in Artava Kshaya with special reference to LH: FSH ratio and Insulin Resistance in Polycystic Ovarian Syndrome.
时间窗: Day0 and Day 90
次要结局
- • To observe the combined effect of Ashwagandha, Gokshura, and Daruharidra Churna on LH: FSH ratio and Insulin Resistance in women diagnosed with Artava Kshaya with special reference to Polycystic Ovarian Syndrome against standard control Metformin Hydrochloride.(• To measure effect of Ashwagandha, Gokshura and Daruharidra on LH: FSH ratio by analyzing Baseline Serum LH, FSH ratio and Insulin Resistance by , Fasting Glucose/Insulin Ratio and Acanthosis Nigricans scoring chart before and after the treatment.)
研究者
Dr Rajani Kagga
Yaswant Ayurvedic College, Post Graduate Training & Research, Kodoli