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Trial of Homeopathy on Management of Menorrhagia

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

Tracking Information
First Submitted Date  ICMJE October 18, 2011
First Posted Date  ICMJE October 26, 2011
Last Update Posted Date November 10, 2011
Study Start Date  ICMJE June 2008
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History Complete list of historical versions of study NCT01460043 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2011)
Health related quality of life [ Time Frame: change from baseline over 3 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2011)
Health related quality of life [ Time Frame: change from baseline over 3 menstrual cycle ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Homeopathy on Management of Menorrhagia
Official Title  ICMJE 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  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Menorrhagia
Intervention  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2011)
25
Original Actual Enrollment  ICMJE 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  ICMJE

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  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01460043
Other Study ID Numbers  ICMJE 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  ICMJE NMP Medical Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Neha Sharma NMP Medical Research Institute
PRS Account NMP Medical Research Institute
Verification Date October 2011

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