Health Condition 1: N920- Excessive and frequent menstruation with regular cycle
Conditions
Interventions
None listed
Sponsors
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES
Eligibility
Inclusion criteria
Inclusion criteria: 1.Women age between 20-50 years. 2.Patient having regular (21-35 days) cycle with Heavy Menstrual Blood (HMB) loss, subjectively or objectively deï¬?ned (Pictorial Blood Assessment Chart â??PBAC3 score more than 100 points) or prolonged bleeding (bleeding more than >7days) for THREE consecutive cycles. 3.Patient willing to participate in study
Exclusion criteria
Exclusion criteria: 1.Hb % 2.Lactating mother 3.Bleeding from the polyps, uterine fibroid, erosion and cancer. 4.Pregnancy and its Complication. 5.History of the bleeding from the site other than the uterus. 6.Women on Anti -Coagulant therapy. 7.Patient with raised liver enzymes twice the upper limit of normal & creatinine more than 1.4 mg%, poorly controlled Hypertension ( >160/100 mm of Hg), poorly controlled Diabetes Mellitus{B.S. (F) > 130 mg% and / or Blood Sugar (2 hr. PP) >250 mg% & HbA1c > 6.5%}. 8.Patients on Combined contraceptive pills/IUCD/DMPA 9.Patients on prolonged ( > 6 weeks) medication with corticosteroids, antidepressants, anti-cholinergics, anticoagulant etc. or any other drugs that may have an influence on the outcome of the study. 10.History of uncontrolled hyperthyroidism or hypothyroidism. 11.Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. 12.History of tuberculosis, Pelvic Inflammatory Diseases (PID). 13.Patients with any other major systemic illness. 14.Patients who are currently participating in any other clinical trial 15.H/o hypersensitivity to the trial drug or any of its ingredients Any other condition which the Principal Investigator thinks may jeopardize the study. 16.Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the amount of uterine bleeding evaluated by PBAC (Pictorial Blood Loss Assessment Chart)/ changes in the duration of bleeding/ attainment of normal quantity of blood loss on interval of cyclesTimepoint: Baseline, end of every cycle up to three cycles and follow-up visit 2 MONTHS OR 2 CYCLE | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in Menorrhagia Impact Questionnaire (MIQ) ScaleTimepoint: Baseline, at the end of intervention period and follow-up visit 2 MONTHS OR 2 CYCLE | — |
Countries
India
Contacts
Public ContactDr Sarada Ota
CARI CCRAS ministry of ayush
Outcome results
None listed