JMIR Publications

ABSTRACT

Background:

Introduction: In India, menorrhagia constitutes about 15 to 20% of all gynecological admissions in an institution. Out of these, 43% are between 20-40 years. This condition is getting worse because of the high prevalence of anemia among Indian women. Heavy menstrual bleeding (menorrhagia) can have a significant impact on women's lives. Medical treatment is usually the first choice in excessive bleeding. However, it reduces menstrual blood loss by only 50%, and up to 50% of women undergo surgical treatment within 5 years. But none of these treatments proved its definite efficacy inspite of high price and side effects. This condition presents a major financial burden on health care services. (Herve Fernandez et al - 2003). In Ayurveda, encouraging work has been done on Ashokarishta, and Trinakantamani pishti is indicated in Ayurveda Classics as well as the Ayurvedic Formulary of India. Also, these medicines have been used in Ayurveda practice for a long time. However, no clinical trial has been carried out on these formulations.

Objective:

The primary objective is to evaluate the efficacy of Ayurveda intervention in the management of menorrhagia (Raktapradara) and the secondary objective is to assess the efficacy of Ayurveda intervention on the quality of life of the women with menorrhagia (Raktapradara).

Methods:

This ongoing study is an open-label Randomised Controlled Interventional trial, with a sample size of 140 both in the trial and standard control group (Including 20% dropouts) and will be carried out within the duration of 36 months. Participants in trial group A will receive Ayurvedic treatment, i.e., Ashokarishta 20ml, Trinkantmani pishti 250 mg, and Tablet IFA one tablet (100mg elemental iron + 1.5mg folic acid) twice a day orally for 03 months. The participants in the standard control group B will receive the tablet Tranexamic acid 500 mg thrice a day for 7 days from 1st day of menses for 3 cycles and Tablet IFA one tablet (100mg elemental iron + 1.5mg folic acid) twice a day orally for 03 months. The primary outcome will include “Attainment of normal menstrual flow “changes in menstrual flow as per the modified Pictorial blood assessment chart (PBAC) Score.” The secondary outcome will include “Improvement in quality of life assessed by Menorrhagia impact questionnaire (MIQ)Score of women with menorrhagia”.

Results:

Primary Outcome Measure is attainment of normal menstrual flow assessed with objective criteria (PBAC) and (Clinically Clotting time) CT will be assessed at baseline, 30th day and end of the treatment 90th day. Secondary Outcome Measure is changes in Menorrhagia impact Questionnaire (MIQ) will be used to assess the improvement in quality of life at every visit

Conclusions:

The Ayurvedic approach may provide an evidence-based therapeutic tactic for the management of Menorrhagia (Raktapradara) Clinical Trial: Clinical Trial Registry (CTRI/2023/05/052929)