Health Condition 1: N939- Abnormal uterine and vaginal bleeding, unspecified
Conditions
Interventions
None listed
Sponsors
Magnet Labs under Mankind Pharma
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women of reproductive age group 18-45 years. 2. Excessive bleeding during menstruation (menstrual blood loss > 80 ml in 1-7 days) or having Pictorial blood loss assessment chart (PBLAC) score more than 100 points for 2 consecutive cycles. 3. Prolonged menstrual bleeding (With the duration of bleeding >7 days) Inter menstrual bleeding 4. Frequent menstrual cycle (interval 5. Patients who are willing to go for relevant investigation 6. Normal gynaecological examination and PAP smear
Exclusion criteria
Exclusion criteria: • Patients with any diagnosed uterine organic pathology like Adenomyosis, and chronic tubo ovarian mass. • Submucosal or intramural fibroids, or subcervical fibroids greater than 3cm. • Patients with systemic diseases like hypertension, diabetic mellitus, congestive cardiac failure etc. • Patients with coagulopathy, liver and thyroid dysfunction etc. • Patient 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. • Hb
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the clinical features of AUB i.e. Mean reduction from baseline in the amount of uterine bleeding evaluated by PBLAC (Pictorial Blood Loss Assessment Chart) at 30 days, day 60 and day 90 Changes in the duration of bleeding. Attainment of normal interval of menstrual cycles Changes in Quality of life and treatment induced changes in menstrual blood loss (MBL) through Menorrhagia Impact Questionnaire Timepoint: 1. Baseline 2. After each menstrual cycle during treatment 3. After each menstrual cycle in folloe up | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Safety and efficacy of Menohelp in AUB â?¢ Pain during menstruation Timepoint: follow up period | — |
Countries
India
Contacts
Public ContactDr Kamini Dhiman
AlIA New Delhi
Outcome results
None listed