Trial of Homeopathy on Management of Menorrhagia
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
|Official Title:||Pilot Study of Homeopathy in Dysfunctional Uterine Bleeding Presenting as Menorrhagia|
- daily assessment of bleeding [ Time Frame: change from baseline over 3 months ] [ Designated as safety issue: Yes ]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.
- Health related quality of life [ Time Frame: change from baseline over 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Study Completion Date:||June 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
|Placebo Comparator: placebo||
corresponding placebo was identical in appearance of homeopathic globule prepared in alcohol.
Other Name: Placebo
Individualized symptom based therapy
Each homeopathic medication was given as 1 g dose of homeopathic preparation in 30c potency. The dose is prepared as lactose globules on which the homeopathic preparation.
Other Name: Homeopathy
Please refer to this study by its ClinicalTrials.gov identifier: NCT01460043
|Principal Investigator:||Neha Sharma||NMP Medical Research Institute|