Trial of Homeopathy on Management of Menorrhagia

Menorrhagia Clinical Trial

Official title:

Pilot Study of Homeopathy in Dysfunctional Uterine Bleeding Presenting as Menorrhagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01460043
• Other study ID #: NMP-0032-HR
• Status: Completed
• Phase: N/A
• First received: October 18, 2011
• Last updated: November 9, 2011
• Start date: June 2008
• Est. completion date: June 2009

Study information

• Verified date: October 2011
• Source: NMP Medical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 49 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menorrhagia
• Metrorrhagia

Intervention

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.
• placebo
corresponding placebo was identical in appearance of homeopathic globule prepared in alcohol.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NMP Medical Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Health related quality of life		change from baseline over 3 months	No