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临床试验/CTRI/2026/02/102780
CTRI/2026/02/102780尚未招募不适用

To Evaluate The Combined Efficacy of Triphala Lekhana Basti And Kanchanara Guggulu Orally in Uterine Fibroids A Single Arm Clinical Study

Dr Geetashree1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年2月15日最近更新:

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

发起方
Dr Geetashree
申办方类型
Other [other(self)]
责任方
Principal Investigator
主要研究者

Dr Geetashree

Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre

研究点 (1)

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