Ayurvedic management of heavy menstrual bleeding or intermenstrual bleeding by the intervention of oral medication and panchkarma therapy.

Completed

• Conditions: Excessive and frequent menstruation with irregular cycle,

• Registration Number: CTRI/2019/08/020743
• Lead Sponsor: All india institute of ayurveda

Brief Summary

This study is a  randomised , open label, parallel group trial to evaluate the clinical efficacy of Kutajashtaka avaleha orally regularly for the period of 3 months with the doses of 5 gm twice a day after meal with water and combination of Kutajashtaka avaleha and Yashtimadhu ghrita matra basti ( 60 ml for 7 days in three consecutive cycles after meal through rectal route after 7th day of menses ) for 3 months for treating heavy and prolonged menstrual bleeding or intermenstrual bleeding in cases of asrigdara. The study will be conducted in All India Institute of Ayurveda, Sarita Vihar, New Delhi. Primary outcome of the study will be reduction in heavy and prolonged menstrual bleeding or intermenstrual bleeding in cases of Asrigdara and secondary outcome will be to assess the efficacy of drug on the change in endometrial thickness and heamoglobin level.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-16
• Study Completion: 2020-02-21
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• patients with symptoms of heavy and prolonged menstrual bleeding or intermenstrual bleeding.
• Patients who are interested and ready to give their written consent for the study work.
• patients who are willing to go for relevant investigations.

Exclusion Criteria

• Any diagnosed uterine organic pathology like uterine fibroid, adenomyosis, chronic tubo-ovarian mass.
• systemic diseases like hypertension, diabetes mellitus, congestive cardiac failure etc.
• coagulopathy, liver and thyroid dysfunction.
• malignancy or undiagnosed neoplasm.
• history of recent abortion.
• active genital tuberculosis.
• bleeding from the polyp and erosion.
• Hb less than 8 gm/dl.
• chronic constipation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
reduction in heavy and prolonged menstrual bleeding or intermenstrual bleeding in the cases of asrigdara.	4 months

Secondary Outcome Measures

Name	Time	Method
To assess the efficacy of drug on the change in endometrial thickness and heamoglobin level.	4 months

Trial Locations

Locations (1)

All India Institute of Ayurveda; 🇮🇳 South, DELHI, India

All India Institute of Ayurveda

🇮🇳South, DELHI, India

Dr Stuti Sharma

Principal investigator

7651863828

stuti.sharma0904@gmail.com