Trial of Homeopathy on Management of Menorrhagia
Pilot Study of Homeopathy in Dysfunctional Uterine Bleeding Presenting as Menorrhagia
1 other identifier
interventional
25
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2008
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 18, 2011
CompletedFirst Posted
Study publicly available on registry
October 26, 2011
CompletedNovember 10, 2011
October 1, 2011
8 months
October 18, 2011
November 9, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
daily assessment of bleeding
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.
change from baseline over 3 months
Secondary Outcomes (1)
Health related quality of life
change from baseline over 3 months
Study Arms (2)
placebo
PLACEBO COMPARATORHomeopathy
EXPERIMENTALIndividualized symptom based therapy
Interventions
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.
corresponding placebo was identical in appearance of homeopathic globule prepared in alcohol.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neha Sharma
NMP Medical Research Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2011
First Posted
October 26, 2011
Study Start
June 1, 2008
Primary Completion
February 1, 2009
Study Completion
June 1, 2009
Last Updated
November 10, 2011
Record last verified: 2011-10