Trial of Homeopathy on Management of Menorrhagia

• ClinicalTrials.gov Identifier: NCT01460043
• Recruitment Status: Completed
• First Posted: October 26, 2011
• Last Update Posted: November 10, 2011
• Sponsor: NMP Medical Research Institute
• Information provided by (Responsible Party): NMP Medical Research Institute

Tracking Information

• First Submitted Date: October 18, 2011
• First Posted Date: October 26, 2011
• Last Update Posted Date: November 10, 2011
• Study Start Date: June 2008
• Actual Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 27, 2011)

daily assessment of bleeding [ Time Frame: 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.

Original Primary Outcome Measures (submitted: October 25, 2011)

daily assessment of bleeding [ Time Frame: change from baseline over 3 menstrual cycles ]

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.

• Current Secondary Outcome Measures (submitted: October 27, 2011): Health related quality of life [ Time Frame: change from baseline over 3 months ]
• Original Secondary Outcome Measures (submitted: October 25, 2011): Health related quality of life [ Time Frame: change from baseline over 3 menstrual cycle ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Trial of Homeopathy on Management of Menorrhagia
• Official Title: Pilot Study of Homeopathy in Dysfunctional Uterine Bleeding Presenting as Menorrhagia
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Treatment
• Condition: Menorrhagia

Intervention

• Drug: Homeopathy
  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.
• Drug: placebo
  corresponding placebo was identical in appearance of homeopathic globule prepared in alcohol.

Study Arms

• Placebo Comparator: placebo
  Intervention: Drug: placebo
• Experimental: Homeopathy
  Individualized symptom based therapy
  Intervention: Drug: Homeopathy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 25, 2011): 25
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 2009
• Actual Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 35 Years to 49 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01460043
• Other Study ID Numbers: NMP-0032-HR
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: NMP Medical Research Institute
• Study Sponsor: NMP Medical Research Institute
• Collaborators: Not Provided

Investigators

• Principal Investigator: Neha Sharma; NMP Medical Research Institute

• PRS Account: NMP Medical Research Institute
• Verification Date: October 2011