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.

Study Overview

• Status: Completed
• Conditions: Menorrhagia
• Intervention / Treatment: Drug: placebo; Drug: Homeopathy

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	change from baseline over 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Health related quality of life	change from baseline over 3 months

Collaborators and Investigators

• Sponsor: NMP Medical Research Institute
• Investigators: Principal Investigator: Neha Sharma, NMP Medical Research Institute

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: October 18, 2011
• First Submitted That Met QC Criteria: October 25, 2011
• First Posted (Estimate): October 26, 2011

Study Record Updates

• Last Update Posted (Estimate): November 10, 2011
• Last Update Submitted That Met QC Criteria: November 9, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Menstruation Disturbances; Uterine Hemorrhage; Menorrhagia
• Other Study ID Numbers: NMP-0032-HR