Pharmaceutico - Clinical Validation of Kalyanaka Kshara in the Management of P.C.O.S Induced Infertility
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Relief in signs and symptoms and significant improvement of objective parameters tests to 50% baseline
研究概览
简要总结
A clinical trail is done to evaluate the efficacy of the Ayurvedic formulation Kalyanaka Kshara in the management of P.C.O.S Induced Infertility and to validate scientifically the observations that would significantly change the LH FSH ratio, Testosterone, Prolactin levels and also signs and symptoms of Polycystic Ovaries. Klayanaka Kshara is a unique herbal formula which has the reference in Astanga Hridaya Chikitsa Stana - a classical text. 50 patients orally 250 mg twice daily for 90 days and to compare the observation with other group in which Rajah Pravartini Vati 250 mg along with Varunadi Kashaya 20 ml administered in 50 patients for 90 days with the observation on 0 - 30 - 60 - 90 days and further follow up for secondary outcome i.e., achievement of fertility, the study would be conducted in India, to complete in 3 years and the trail time being 18 months. Primary outcome measures will be relief in signs and symptoms (subjective parameters), subsiding the P.C.O.S symptoms and achieve ovulatory cycles, fertility
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Married infertility patients with P.C.O.D. (Rotterdam criteria) Irregular menses scanty menses due to Anovulatory cycle Anovulation and Oligo amennorohoea Elevated LH (LH:FSH ratio >3) Clinical or biochemical evidence of Hyperandrogenism Polycystic ovary (more than 10 follicles in a ovary or one cyst more than 10 mm) Willing to give pre-informed consent for the study.
排除标准
- •Unmarried patients with P.C.O.D. Age below 20 years and above 40 years Patients associated with other gynaecological disorders Patients suffering with any chronic diseases Women having the history of primary amenorrhea Patients with Tubercular endometritis Patients with congenital anomalies in female genital tract Patients with chronic liver disease, renal disorder, etc.
- •Patients with metabolic and other Endocrinal disorders like Diabetes Mellitus Patients with Hypothyroidism.
结局指标
主要结局
Relief in signs and symptoms and significant improvement of objective parameters tests to 50% baseline
时间窗: Every month | 30th day, 60th day, 90th day
次要结局
- Improvement in objective parameters(Achievement of Ovulation and Fertility)