TO STUDY EFFICACY AND SAFETY OF CAPSULE UTRHEALTH COMPARED WITH PLACEBO IN WOMEN WITH HEAVY MENSTRUAL BLEEDING

Phase 2

• Conditions: Health Condition 1: null- Women with heavy menstrual bleeding

• Registration Number: CTRI/2015/02/005584
• Lead Sponsor: Charak Pharma Pvt Ltd CPP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Inclusion Criteria

The participant may enter the trial if ALL of the following apply:

Participant is willing and able to give informed consent for participation in the trial

Females below 45 years and above 18 years who have DUB in the form of moderate to heavy menstrual bleeding presented as complaints of soaking through one or more sanitary pads or tampons every hour for several consecutive hours, needing to use double sanitary protection to control menstrual flow, needing to wake up to change sanitary protection during the night, bleeding for longer than a week

Participant has clinically acceptable laboratory results

In the Investigatorâ??s opinion, is able and willing to comply with all trial requirements

Exclusion Criteria

Exclusion Criteria

The participant may not enter the trial if ANY of the following apply:

Women with abnormal vaginal bleeding wherein dysfunctional uterine bleeding is not confirmed

Clinically suspected uterine leiomyomas, adenomyosis, polyps

Clinically suspected malignancy of uterus or cervix

Severe anemia with Hb less than 8 gm/dL

History of pregnancy related conditions like miscarriages, abortion, IUGR, etc

Participants who had undergone any surgery in past 12 weeks

History of hyperthyroidism and hypothyroidism

Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participantâ??s ability to participate in the trial

Participants who have participated in another research trial involving an investigational product in the past 12 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified