Eladi kasaya in the management of Asrigdara

Phase 3

Not yet recruiting

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

• Registration Number: CTRI/2022/12/048303
• Lead Sponsor: Mahatma gandhi ayurved college, hospital and research centre

Brief Summary

This clinical trial has been conducted as a research work under the Ph.D. programme.

This is a randomized, single blind, standard controlled, equivalence clinical trial to evaluate the comparative efficacy of Eladi kasaya versus tablet Tranexamic acid in the management of Asrigdara (Heavy menstrual bleeding)

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-01-12
• Study Start: 2023-02-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 92

Inclusion Criteria

• Patients who are willing to give written consent for the trial.
• Patients between the age group of 18 to 45years.
• Patients with excessive bleeding (>80ml) for at least 2 consecutive cycles.

Exclusion Criteria

• Patients with any diagnosed uterine organic pathology like Uterine Fibroid, Adenomyosis, Chronic tubo ovarian mass.
• Polycystic ovaries 2.
• Patients with systemic diseases like hypertension, diabetes mellitus, congestive cardiac failure etc.
• Patients with coagulopathy 4.
• Liver dysfunction 5.
• Thyroid dysfunction 6.
• Patients with malignancy or undiagnosed neoplasm.
• Patients with history of recent abortion.
• Patients with active genital tuberculosis.
• Bleeding from the polyps and erosion.
• IUCD in utero, pelvic endometriosis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
reduction of blood loss calculated by pictorial blood assessment chart	0,4weeks, 8weeks, 12weeks, 16weeks

Secondary Outcome Measures

Name	Time	Method
safety of given medication through occurance of adverse drug reaction
reduction in pain assessed by visual analog scale	4weeks, 8weeks, 12 weeks, 16weeks
improvement in hemoglobin	0 and 16 weeks
quality of life assessment using menorrhagia impact quessionnaire	0 and 16 weeks

Trial Locations

Locations (1)

Mahatma gandhi ayurved college and hospital; 🇮🇳 Wardha, MAHARASHTRA, India

Mahatma gandhi ayurved college and hospital

🇮🇳Wardha, MAHARASHTRA, India

Dr Trapti Agrawal

Principal investigator

9899137789

tripti.obs@gmail.com