To Evaluate The Combined Efficacy of Triphala Lekhana Basti And Kanchanara Guggulu Orally in Uterine Fibroids A Single Arm Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Menstrual bleeding pattern
研究概览
简要总结
This is an open labelled single arm clinical study To evaluate the efficacy of Triphala lekhana basti and Kanchanara guggulu orally in uterine fibroids A total of 20 patients will be administered Triphala kashaya niruha basti will be administered in the dosage of 600ml in Kalabasti course wherein 6 triphala kashaya niruha basti will be administered on 2nd to 7th day in the morning empty stomach and Anuvasana in the afternoon after lunch. Two Anuvasana basti with
Panchatiktaka ghrita+ tila taila in the dose of 40ml each will be administered on 1st and 8th day in the morning and afternoon immediately after food and Kanchanara guggulu will be administered orally 1.5gm from 9th day to 90th day of treatment followed by a followup period of 1 month
The study will be conducted in Sri Dharamasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi The
primary outcome measures will be assessed by subjective and objective parameters
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
- 20.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •Subjects fulfilling the diagnostic criteria Women aged between 20-45 yrs Married and unmarried women Subjects fit for Lekhana basti.
排除标准
- •Hb less than 9gm% Patients with heavy menstrual bleeding Pedunculated Fibroid Subjects under hormonal therapy Pregnant and lactating women Systemic diseases intervening the treatment Malignant conditions Postmenopausal women.
结局指标
主要结局
Menstrual bleeding pattern
时间窗: 90 days treatment and 1 month followup
Pelvic pain
时间窗: 90 days treatment and 1 month followup
Constipation
时间窗: 90 days treatment and 1 month followup
Increased frequency of micturition
时间窗: 90 days treatment and 1 month followup
Dyspareunia
时间窗: 90 days treatment and 1 month followup
OBJECTIVE PARAMETERS:
时间窗: 90 days treatment and 1 month followup
Number of fibroids
时间窗: 90 days treatment and 1 month followup
Size and location of fibroids
时间窗: 90 days treatment and 1 month followup
Uterine size
时间窗: 90 days treatment and 1 month followup
Endometrium thickness
时间窗: 90 days treatment and 1 month followup
patients will be assessed on the basis of Subjective & Objective parameters.
时间窗: 90 days treatment and 1 month followup
SUBJECTIVE PARAMETERS-
时间窗: 90 days treatment and 1 month followup
Dysmenorrhea
时间窗: 90 days treatment and 1 month followup
次要结局
- Improvement in pressure symptoms(Regularization of menstrual cycle)
研究者
Dr Geetashree
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre
