A Comparative Clinical study To evaluate the effect of Guduchidantyadi Vati & Guduchidantyadi Malahar in Acharana Yonivyapad WSR to Pruritus Vulvae
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
- To assess the efficacy of oral administration of Guduchidantyadi Vati and Guduchidantyadi Malahar in Pruritus vulvae
研究概览
简要总结
Type of study-Randomized comparative parallel open clinical trial, to evaluate and compare the effect of Guduchidantydi Vati and Guduchidantyadi Malahar in Acharana yonivyapada( pruritus vulvae). 40 patients in the age group of 18 to 45 years will be registered randomly from OPD and IPD of PG department of Prasuti tanta and Stri roga State Ayurvedic College and Hospital Lucknow after taking permission from Institutional Ethics committee and consent from the patient.
Patients will be allocated in group A and Group B of 20 patients each.
Group A-Guduchidantyadi Vati will be administrated orally for 21 days
Group B- Guduchidantyadi Malahar local application for 21 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients willing to participate in trial Adult Female who are in age group of 18-45 years Only married patient Patients having pruritus vulvae as a cardinal symptom with or without vaginal discharge.
排除标准
- •Patients below 18 years and above 45 years Patients unwilling too participate in the trial Patients after menopause.
- •Patients who are willing to conceive.
- •Patients of uterine prolapse and Ca-cervix.
- •Patients on oral contraceptives or using intra uterine contraceptive device.
- •Patients with diabetes mellitus, tuberculosis, severe hypertension, jaundice.
- •Patients with chronic cervicitis, fibroid and malignancy.
- •VDRL, HIV, HBsAg positive patient.
结局指标
主要结局
To assess the efficacy of oral administration of Guduchidantyadi Vati and Guduchidantyadi Malahar in Pruritus vulvae
时间窗: Trial will be conducted for 1 month ( 21 days with medicine and 7 days without medicine) .Patient will be followed once a week during treatment and 7 days after the treatment is completed.
次要结局
- To assess the efficacy of trial drug on subjective parameters white discharge p/v, malodor, vulvar pain , coital frequency , dyspareunia , burning micturition & inflammation in vulva(1 month)