To evaluate the effectiveness of ayurvedic management for heavy menstrual bleeding.

Phase 2/3

Not yet recruiting

• Conditions: Excessive and frequent menstruation with regular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH,

• Registration Number: CTRI/2021/04/032992
• Lead Sponsor: Dr Supriya Subhash Padekar

Brief Summary

The present study is the comparative clinical study for completion under MUHS Nashik university.

Total duration of trial is 1 year 6 months 15 days.



Title:

A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECTIVENESS OF KUTAJASHTAK KWATHA AND TRANEXAMIC ACID IN RAKTAPRADAR (MENORRHAGIA) WITH SPECIAL REFERENCE TO CYCLIC HEAVY MENSTRUAL BLEEDING- AN OPEN RANDOMISED CONTROL TRIAL.



study group- 31 patients with Kutajashtak kwatha (48ml) with Madhu anupan twice a day before food (apaan kaal)  from 3rd day of menses for 5 days for 3 consecutive menstrual cycles.



Comparative group- 31 patients with Tab. Tranexamic acid 500 mg orally twice a day after food from 3rd day of menses for 5 days for 3 consecutive menstrual cycles.



Study centre- Dr. G. D. Pol foundation Y. M. T. Ayurved Medical college and Hospital Kharghar



PG scholar- Dr. Supriya Subhash Padekar



Guide- Dr. Mayura M. Devadiga

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-04-20
• Study Start: 2021-04-22

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 62

Inclusion Criteria

• Age group of patients between 18 to 45 years female.
• Patient with cyclical excessive Per vaginal bleeding in the form of duration more than 7 days or quantity more than 80ml or both with or without clots during menstrual cycle.
• Haemoglobin 10 gm% or more.
• Patient with PID.
• Patient with uterine fibroid of size less than 12 weeks of pregnancy and patient willing to avoid surgery.
• Patient with adenomyosis & pelvic endometriosis.

Exclusion Criteria

• Patients suffering from moderate/severe anaemia (Haemoglobin less than 10 gm%) 2.
• Suspected cases of spontaneous, threatened or incomplete abortion.
• Patients with systemic disorders like Thyroid dysfunction, Hypertension, Tuberculosis, Diabetes mellitus.
• Patient using OC pills.
• Patient with IUCD (Intra Uterine Contraceptive Device).
• Genital Malignancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stoppage of heavy menstrual bleeding.	Baseline 3 visits. | Each visit with Follow up on 5th,7th,9th day of menses for 3 consecutive menstrual cycles.

Secondary Outcome Measures

Name	Time	Method
To study the effectiveness of Kutajashtak Kwatha and Tranexamic acid on associated symptoms like pain in lower abdomen, passage of clots, odour and staining of menstrual blood, fatigue.	Follow up on 5th,7th,9th day of menses for 3 consecutive menstrual cycles.

Trial Locations

Locations (1)

Dr. G. D. Pol foundation Y. M. T ayurved medical college and hospital Kharghar; 🇮🇳 Raigarh, MAHARASHTRA, India

Dr. G. D. Pol foundation Y. M. T ayurved medical college and hospital Kharghar

🇮🇳Raigarh, MAHARASHTRA, India

Dr Supriya Subhash Padekar

Principal investigator

8669047202

dr.supriyapadekar@gmail.com