A Randomized Controlled Clinical Trial to Study the Effect Of Sharapunkha Madhu Pratisaran in Garbhashay Grivagat Vrana with Special Reference to Cervical Ectopy.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Reduction in pruritis vulvae, backache, per vaginal discharge,
研究概览
简要总结
Prevalence rate of Garbhashay grivagat vrana i.e. cervical ectopy is 15%. Ectopy is treated with cauterization, cryosurgery, laser vaporization etc. in modern science which has its own side effects. Ayurvedic treatment for managing Garbhashay grivagat vrana could be safe, non surgical , easily available and cost effective without any side effects. Sharapunkha madhu has great impact on treating Garbhashay grivagat vrana as it has Vranashodhak and vranaropak properties. Clinical trial to evaluate efficacy of sharapunkha madhu pratisaran with triphala kwath yoni dhawan would be beneficial to expand knowledge about management alternative. A clinical study of sharapunkha madhu pratisaran has not yet been assessed in Garbhashay grivagat vrana . So it will help to fill knowledge gap .
Including the married female patient having sign and symptoms of Garbhashay grivagat vrana like vaginal discharge, pruritis vulvae, backache, lower abdominal pain between age group of 18-49 year who fulfill clinical diagnostic criteria. Written consent is taken from patient to ensure ethical compliance and transparency in research process. Sample size calculated is 35 each group by using formula by Daniel 1999. Simple random sampling technique will be used. Total 70 number of patients will be divided in two group named as Group A (trial group and Group B (control group). Sharpunkha madhu pratisaran with triphala kwath yoni dhawan to group A (Trial group), tankan madhu pratisaran with triphala kwath yoni dhawan to group B (control group) will be given to patients. Drugs will be purchased from GMC certified pharmacy. Both drugs will be
administered for 10 days. All SOP of choorna preparation and Yoni Dhawan procedure will be
followed throughout the clinical trial. Observation will be done on 0th and 5th day and 10th day of treatment.
Result will be drawn on basis of assessment criteria and statistical analysis. Discussion will be done
on the basis of observation and result obtained during treatment. Summary will be drawn, and
thesis work will be summarized with the help of statistical analysis. Conclusion will be drawn out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.The signs and the Symptoms of Garbhashaya Grivagata Vrana like Vaginal discharge (Yonisrava), Pruritis vulvae (Yonikandu), Backache (Katishoola). 2.Age group.
- •49 years. 3.Married women. 4.Controlled Diabetic.
排除标准
- •1.Post-natal women.
- •2.pregnant women.
- •3.unmarried women.
- •4.Cervical Malignancy.
结局指标
主要结局
Reduction in pruritis vulvae, backache, per vaginal discharge,
时间窗: 10 Days
size of erosion
时间窗: 10 Days
次要结局
- Where the trial groups stands in comparison with control group(1st day, 5th day, 10th day)
研究者
Dr Vaishnavi Adinath Kale
SMBT Ayurved College and Hospital