A single arm clinical trial to evaluate the effect of Koshtashodhana and Haridradigana ghana vati in the management of Artavadosha associated with Non-Hyperandrogenic Polycystic Ovary Syndrome
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction in inter-menstrual interval
研究概览
简要总结
PCOS is characterized by irregular menstrual cycles (oligomenorrhea/Amenorrhea), anovulation, acne, hirsutism, obesity with distinct abdominal obesity and infertility. Modified Rotterdam criteria as most accepted criteria for diagnosis of PCOS requiring presence of any two conditions out of three - oligomenorrhea and/or Amenorrhea, hyperandrogenism (clinical and/or biochemical) ,Polycystic ovaries diagnosed by USG accompanied with detailed description of four types of phenotypes(A,B,C and D). Phenotype D includes ovulatory dysfunction (Oligomenorrhea/Amenorrhea) and polycystic ovarian morphology(≥ 12 follicles in any one ovary measuring 2-9mm and ovarian volume >10cm2 ).This study aims to evaluate the effect of Koshtashodhana and Haridradigana ghana vati be in the management of Artavadosha associated with Non-Hyperandrogenic Polycystic ovary Syndrome. This study involves single group study with 40 patients. Primary Expected Outcome of study is reduction in inter-menstrual interval and Secondary Expected Outcome to be reduction in ovarian volume,reduction in no. of cysts in ovary and decrease in Fasting blood sugar level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Married and unmarried females willing to take part in study BMI more than or equal to 18.5 kg/m2 to less than or equal to 35kg/m2 Interval of menstrual cycles- 38 to 90 days in the past 2 cycles or less than 9 menstrual periods in one year Already diagnosed and newly diagnosed patients of PCOS with phenotype D (non –hyperandrogenic PCOS) Patients who have informed written consent.
排除标准
- •Subjects with Hyperthyroidism and uncontrolled hypothyroidism Subjects taking any hormonal medication from last three months at the time of screening Subjects with Hyperprolactinemia having Serum Prolactin more than 30 ng/ml Subjects with Hyperandrogenism Serum Testosterone level more than 0.6ng/ml Subjects with Modified Ferriman Gallway Score more than 8 Subjects having uncontrolled hypertension BP more than 130/90mmHg and DM II FBS more than 150mg/dl Subjects suffering from any kind of congenital disease for example congenital adrenal hyperplasia Subjects having any pelvic pathologies like androgen secreting tumours uterine fibroid endometriosis adenomyosis pelvic inflammatory diseases etc Pregnant lactating women.
结局指标
主要结局
Reduction in inter-menstrual interval
时间窗: baseline to 90th day
次要结局
- Reduction in ovarian volume(Reduction in no. of cysts in ovary)
研究者
Dr Sulekha
Shri Dhanwantry Ayurvedic College and hospital sector 46 B Chandigarh,160047 India