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Trial of Homeopathy on Management of Menorrhagia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01460043
Recruitment Status : Completed
First Posted : October 26, 2011
Last Update Posted : November 10, 2011
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Menorrhagia Drug: Homeopathy Drug: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Pilot Study of Homeopathy in Dysfunctional Uterine Bleeding Presenting as Menorrhagia
Study Start Date : June 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Placebo Comparator: placebo Drug: placebo
corresponding placebo was identical in appearance of homeopathic globule prepared in alcohol.

Experimental: Homeopathy
Individualized symptom based therapy
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Health related quality of life [ Time Frame: change from baseline over 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01460043

Sponsors and Collaborators
NMP Medical Research Institute
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Principal Investigator: Neha Sharma NMP Medical Research Institute
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Responsible Party: NMP Medical Research Institute Identifier: NCT01460043    
Other Study ID Numbers: NMP-0032-HR
First Posted: October 26, 2011    Key Record Dates
Last Update Posted: November 10, 2011
Last Verified: October 2011
Additional relevant MeSH terms:
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Uterine Hemorrhage
Uterine Diseases
Pathologic Processes
Menstruation Disturbances