Trial of Homeopathy on Management of Menorrhagia
- Conditions
- Menorrhagia
- Interventions
- Drug: placeboDrug: Homeopathy
- Registration Number
- NCT01460043
- Lead Sponsor
- NMP Medical Research Institute
- Brief Summary
The purpose of this study is to compare outcomes and quality-of-life issues in the treatment of menorrhagia, this randomized double blind controlled trial compared homeopathy and placebo. Clinical criteria were confirmed the diagnosis, and subjective assessment of the condition was performed during one pre-treatment and three treatment cycles. outcome measures were bleeding days, intensity. average pads used during menstrual cycle, abdominal \& back pain, General health and overall satisfaction.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 25
- Age between 35-49 years with regular heavy menstrual bleeding
- menstrual loss requiring more than 5 Pads/tampons per day
- menstrual cycle longer than 6 days
- Organic causes of menorrhagia
- History of renal or hepatic impairment,
- Endocrine disorder including diabetes, thyroidism
- Thromboembolic disease,
- Inflammatory bowel disease,
- Peptic or intestinal ulceration, or coagulation or fibrinolytic disorders and --Malignancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo - Homeopathy Homeopathy Individualized symptom based therapy
- Primary Outcome Measures
Name Time Method daily assessment of bleeding change from baseline over 3 months bleeding days, intensity of bleeding, average pads used, back and abdominal pain associated.daily assessment during menses were completed by participants at baseline before randomization and at each menses for 3 month of intervention period.
- Secondary Outcome Measures
Name Time Method Health related quality of life change from baseline over 3 months