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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2015/02/005584
• Date of registration: 26-02-2015
• Prospective Registration: No
• Primary sponsor: Charak Pharma Pvt Ltd CPPL
• Public title: TO STUDY EFFICACY AND SAFETY OF CAPSULE UTRHEALTH COMPARED WITH PLACEBO IN WOMEN WITH HEAVY MENSTRUAL BLEEDING
• Scientific title: Clinical Trial to Evaluate the Efficacy and Safety of Utrihealth Capsule in Dysfunctional Uterine Bleeding (DUB) A Double Blind Placebo Controlled Trial - UTRH
• Date of first enrolment: 02-12-2014
• Target sample size: 60
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=10660
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded
• Phase: Phase 2/ Phase 3

Countries of recruitment

India

Contacts

• Name: Dr Seema Mehre
• Affiliation: Y.M.T Ayurvedic Medical College, Kharghar, Navi Mumbai

• Name: Dr Seema Mehre
• Affiliation: Y.M.T Ayurvedic Medical College, Kharghar, Navi Mumbai

Key inclusion & exclusion 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

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



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Women with heavy menstrual bleeding

Intervention(s)

Intervention1: capsule Utrihealth: one capsule twice a day for 12 weeks
Control Intervention1: placebo: one capsule twice a day for 12 weeks

Primary Outcome(s)

To study the efficacy of Capsule Utrihealth in regulation of heavy menstrual bleeding in women of reproductive ageTimepoint: Number of patients showing reduction in menstrual blood loss in women of reproductive age assessed by Menorrhagia Impact Questionnaire t baseline , 4weeks, 8th weeks and12 weeks of treatment

Secondary Outcome(s)

1.To assess haematinic activity of Capsule Utrihealth compared with Placebo in patients with Dysfunctional Uterine Bleeding (DUB)

2.To assess safety and tolerability of Capsule Utrihealth compared with Placebo in patients with Dysfunctional Uterine Bleeding (DUB

Timepoint: 1.Number of patients showing improvement in Hemoglobin% after 12 weeks of treatment





2.Investigatorâ??s global assessment

3.Patientsâ?? global assessment

4. Patientsâ?? reporting and Investigatorâ??s assessment of adverse reactions (AR)

Secondary ID(s)

CPPL-INVD-UTRH-052014

Source(s) of Monetary Support

Charak Pharma Pvt Ltd, (CPPL) Charak Pharma Pvt Ltd. 501/A,Poonam Chambers, Dr.A.B.Road, Worli, Mumbai-400018

Ethics review

Status: Approved
Approval date: 06/02/2015
Contact:

Institutional Ethics Committee of Dr G. D. Pol Foundation YMT Ayurvedic Medical College & Hospital, Sector 4, Kharghar, Navi Mumbai, Maharashtra 410210