A PROSPECTIVE OPEN LABELLED, NON-RANDOMIZED, PHASE II CLINICAL TRIAL OF “ATTATHI CHOORANAM†IN THE MANAGEMENT OF “RAKTHA SOORAI VAAYU†(POLY CYSTIC OVARIAN SYNDROME)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Diagnosis of RAKTHA SOORAI VAAYU and evaluation of the therapeutic efficacy of Attathi chooranam. It is assessed by the improvement in the score of irregular menstruation (Intermenstrual period & duration of bleeding) before and after treatment.
研究概览
简要总结
The study is a prospective open labelled, non-randomised, phase II clinical trial to determine the efficacy and safety of ATTATHI CHOORANAM in patients with RAKTHA SOORAI VAAYU ( POLY CYSTIC OVARIAN SYNDROME). The trial drug is processed from raw herbs and mineral. In this clinical trial to be held at GSMC, Palayamkottai, 40 patients (20 in OPD + 20 in IPD) will be recruited and the trial drug will be administered at the dose of 40 mg/ Kg/ BW TDS A/F along with Honey or ghee as adjuvant for a period of 48 days. All the study related data will be recorded and documented in a separate file for each patients. In case of any adverse event (AE) is noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patient will be given in OPD, GSMC, Palayamkottai. During this trial all the efficacy and safety parameters will be recorded in the CRF. After completion of trial all the study related data will be analysed statistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 15.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Marital Status : Married / Unmarried II.
- •Symptoms -Irregular menstruation, oligomenorrhoea (or) amenorrhoea (or) dysmenorrhoea (or) dysfunctional uterine bleeding -Hirsuitism and obesity III.
- •Patient willing to take USG pelvis IV.
- •Patient willing to undergo routine blood investigation V.
- •USG pelvis showing polycystic ovaries VI.
- •Patient willing to participate in trial and signing in consent form.
排除标准
- •History of recent hormone therapy (within one year) II.
- •Lactating mother.
- •History of renal disease V.
- •History of Liver diseas VI.
- •Uterine anomalies.
结局指标
主要结局
Diagnosis of RAKTHA SOORAI VAAYU and evaluation of the therapeutic efficacy of Attathi chooranam. It is assessed by the improvement in the score of irregular menstruation (Intermenstrual period & duration of bleeding) before and after treatment.
时间窗: 48 days
次要结局
- Changes in the polycystic swellings of the ovaries in USG pelvis and reduction of other symptoms.(48 days)