Health Condition 1: null- Women with heavy menstrual bleeding
Conditions
Interventions
Intervention1: capsule Utrihealth: one capsule twice a day for 12 weeks
Control Intervention1: placebo: one capsule twice a day for 12 weeks
Sponsors
Charak Pharma Pvt Ltd CPPL
Eligibility
Inclusion 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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
India
Contacts
Public ContactDr Seema Mehre
Y.M.T Ayurvedic Medical College, Kharghar, Navi Mumbai
Outcome results
None listed