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Trial of Homeopathy on Management of Menorrhagia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NMP Medical Research Institute
ClinicalTrials.gov Identifier:
NCT01460043
First received: October 18, 2011
Last updated: November 9, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention
Menorrhagia
 Drug: Homeopathy
Drug: placebo

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Vaginal Bleeding
U.S. FDA Resources

Further study details as provided by NMP Medical Research Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Health related quality of life [ Time Frame: change from baseline over 3 months ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: June 2008
Study Completion Date: June 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Drug: placebo
corresponding placebo was identical in appearance of homeopathic globule prepared in alcohol.
Other Name: Placebo
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.
Other Name: Homeopathy

  Eligibility

Ages Eligible for Study:   35 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01460043

Sponsors and Collaborators
NMP Medical Research Institute
Investigators
Principal Investigator: Neha Sharma NMP Medical Research Institute
  More Information

No publications provided

Responsible Party: NMP Medical Research Institute
ClinicalTrials.gov Identifier: NCT01460043     History of Changes
Other Study ID Numbers: NMP-0032-HR
Study First Received: October 18, 2011
Last Updated: November 9, 2011
Health Authority: India: Indian Council of Medical Research

Additional relevant MeSH terms:
Menorrhagia
Metrorrhagia
Uterine Hemorrhage
Uterine Diseases
 Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes
Hemorrhage

ClinicalTrials.gov processed this record on May 16, 2013