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Trial of Homeopathy on Management of Menorrhagia

Primary Purpose

Menorrhagia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Homeopathy
placebo
Sponsored by
NMP Medical Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menorrhagia

Eligibility Criteria

35 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    placebo

    Homeopathy

    Arm Description

    Individualized symptom based therapy

    Outcomes

    Primary Outcome Measures

    daily assessment of bleeding
    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

    Full Information

    First Posted
    October 18, 2011
    Last Updated
    November 9, 2011
    Sponsor
    NMP Medical Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01460043
    Brief Title
    Trial of Homeopathy on Management of Menorrhagia
    Official Title
    Pilot Study of Homeopathy in Dysfunctional Uterine Bleeding Presenting as Menorrhagia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2008 (undefined)
    Primary Completion Date
    February 2009 (Actual)
    Study Completion Date
    June 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NMP Medical Research Institute

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Menorrhagia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Title
    Homeopathy
    Arm Type
    Experimental
    Arm Description
    Individualized symptom based therapy
    Intervention Type
    Drug
    Intervention Name(s)
    Homeopathy
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    corresponding placebo was identical in appearance of homeopathic globule prepared in alcohol.
    Primary Outcome Measure Information:
    Title
    daily assessment of bleeding
    Description
    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.
    Time Frame
    change from baseline over 3 months
    Secondary Outcome Measure Information:
    Title
    Health related quality of life
    Time Frame
    change from baseline over 3 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    49 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Neha Sharma
    Organizational Affiliation
    NMP Medical Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Trial of Homeopathy on Management of Menorrhagia

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