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Clinical Trials/CTRI/2015/02/005584
CTRI/2015/02/005584
Recruiting
Phase 2

Clinical Trial to Evaluate the Efficacy and Safety of Utrihealth Capsule in Dysfunctional Uterine Bleeding (DUB)A Double Blind Placebo Controlled Trial - UTRH

Charak Pharma Pvt Ltd CPP0 sites60 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Charak Pharma Pvt Ltd CPP
Enrollment
60
Status
Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Charak Pharma Pvt Ltd CPP

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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