An exploratory single arm study on the efficacy of maha agad in the management of dushi visha janya artava kshaya (poly cystic ovarian syndrome )
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction of ovarian cyst (size, volume & number).
研究概览
简要总结
Type of study : Interventional
Purpose : Treatment
Timing : Prospective
End point : Effectiveness/Therapy
Duration : 60 days
Sample size : 30
CRITERIA FOR SELECTION : Patients will be selected from OPD and IPD of PGIA, Jodhpur and registered dispensary/hospital asper the criteria of inclusion strictly.
• Written voluntary informed consent will be obtained from each patient before starting the trial.
The study will be completed on minimum 30 clinically diagnosed patients of PCOS.
POSOLOGY: Maha Agad
Kalpana -Vati
Dose -2 Tab of 500 mg
Route of administration- Orally
Time of administration- 3 times a day after meal
Anupana -Luke warm water
Duration- 60 days
FOLLOWUP****STUDY
**1.**Follow up after 15 days completion of the trial will be in 60 days.
2. Improvement and other effect will be noted.
3. Laboratory investigations will be repeated if seemed necessary.
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 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patient diagnosed cases of PCOS by the ROTTERDAM CRITERIA.
- •Patient with age group between 18-45 years.
- •Patient willing to give consent for clinical trial.
- •Patient having history of consuming Dushi Visha (as per mentioned in questionnaire) for a long period of time.
排除标准
- •Patient suffering from adrenal or ovarian tumor.
- •Patient suffering from cushing syndrome, congenital adrenal hyperplasia, hyperprolactinemia.
- •3.Patient suffering from any systemic disorder and congenital disorder.
- •4.Patient suffering from pelvic pathology including fibroid uterus, cervical polyp.
- •5.Women taking oral contraceptive pills.
结局指标
主要结局
Reduction of ovarian cyst (size, volume & number).
时间窗: 60 Days
次要结局
- Changes in the secondary objective.(1. Improvement in hormonal assay.)
研究者
Dr Sristi Purohit
Post Graduate Institute of Ayurved Jodhpur 342037