Health Condition 1: N920- Excessive and frequent menstruation with regular cycle
Conditions
Interventions
Intervention1: Botropase: Dosage: 1ml(1CU)
Route: Intravenous
Frequency per day: BID (twice a day)
Duration: 1 Day, (Day 2, Day3- SOS basis)
Control Intervention1: Active Control Arm:
Regimen: Tranexa
Sponsors
Jagdale industries pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 18-49 years 2. Gender: Female 3. Agrees to provides a written or electronic copy of the signed informed consent form (ICF) 4. Diagnosed and admitted with Menorrhagia (admitted at least 1day to define the bleeding scale) 5. Patients Without any systemic diseases interfering with or influencing coagulation. 6. Patients with hemogram, bleeding time and clotting time within normal limits and without any bleeding and clotting disorder. 7. Has an Aadhar ID or equivalent ID proof, smartphone/mobile connectivity and is willing to receive calls and messages connect by health care workers assigned to this project and authorized by this investigator. 8. Agrees not to self-medicate or take any other therapies during the study and has not been on any such medications other ayurvedic, homoeopathic, Siddha, or other forms of medications for the past 1 (one) week and agrees to not use during the study period.
Exclusion criteria
Exclusion criteria: 1. Individuals not willing to give written consent (wet-ink/electronic) 2. Known history of allergy or contraindications for Botropase Injection /its components and/or to Tranexamic Acid/ Its components. 3. Patients with mental illness who cannot comprehend questionnaires. 4. Patients with conditions that affect blood coagulation- Hemophilia, Hypercoagulability, Thromboembolic predisposition like deranged lipid profile, any bleeding disorder found during screening. 5. Individuals on any other medications or nutritional supplements that may influence Botropase i.e. any other coagulant or anti-coagulant. 6. Individuals not willing to follow protocol specified guidelines. 7. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening for this study or during the course of the study. 8. History of renal failure or dialysis, hypercalcemia, severe liver disease (cirrhosis), sarcoidosis, or other granulomatous diseases (Wegener) 9. Previously diagnosed cases of immune-compromised status like HIV, Hepatitis B/C, Tuberculosis, Cancer, etc. or deranged liver or kidney tests 10. Subjects taking or need to take systemic/oral steroid treatment and or any kind of immunosuppressive therapy in the pre-study and during the study period 11. Subjects participating in any other clinical study or having participated in any other study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Mean Reduction from Baseline in terms of Menstrual Blood Loss (MBL) measured in ml; assessed using the Pictorial Blood Loss Assessment Chart. [Time Frame: Baseline MBL over 3 menstrual cycles] 2.Hemoglobin and hematocrit levels (on Day 0, 1, 2, 3, Cycle 2 and Cycle 3). 3.BT, CT- measured on D0, D1, D2 and Day 3 4.Need for Blood Transfusion – assessed between Day1 & Day 3 5.Reduction in Large Stains- assessed on Day 1,2,3, Cycle 2, Cycle 3 6.Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated with Heavy Menstrual Bleeding 7.Patient Reported Outcome Measure of Limitations in Physical Activities Associated with Heavy Menstrual Bleeding 8.Menorrhagia multi-attribute quality-of-life scale (MMAS) score Timepoint: Day1,2,3, Cycle 2, Cycle 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess safety of Botropase InjectionTimepoint: Day1,2,3, Cycle 2, Cycle 3 | — |
Countries
India
Contacts
Public ContactMr Raghavendra K V
Radiant Research Services Pvt Ltd
Outcome results
None listed