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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

October 18, 2011
November 9, 2011
June 2008
February 2009   (final data collection date for primary outcome measure)
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.
daily assessment of bleeding [ Time Frame: change from baseline over 3 menstrual cycles ] [ 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.
Complete list of historical versions of study NCT01460043 on ClinicalTrials.gov Archive Site
Health related quality of life [ Time Frame: change from baseline over 3 months ] [ Designated as safety issue: No ]
Health related quality of life [ Time Frame: change from baseline over 3 menstrual cycle ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Trial of Homeopathy on Management of Menorrhagia
Pilot Study of Homeopathy in Dysfunctional Uterine Bleeding Presenting as 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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Menorrhagia
  • 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
  • Drug: placebo
    corresponding placebo was identical in appearance of homeopathic globule prepared in alcohol.
    Other Name: Placebo
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Experimental: Homeopathy
    Individualized symptom based therapy
    Intervention: Drug: Homeopathy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
June 2009
February 2009   (final data collection date for primary outcome measure)

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.
Female
35 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01460043
NMP-0032-HR
Yes
NMP Medical Research Institute
NMP Medical Research Institute
Not Provided
Principal Investigator: Neha Sharma NMP Medical Research Institute
NMP Medical Research Institute
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP