Trial of Homeopathy on Management of Menorrhagia

Sponsor

NMP Medical Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01460043

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Menorrhagia	Drug: Homeopathy Drug: placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

Pilot Study of Homeopathy in Dysfunctional Uterine Bleeding Presenting as Menorrhagia

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Feb 1, 2009

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

daily assessment of bleeding [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.

Secondary Outcome Measures

Health related quality of life [change from baseline over 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

NMP Medical Research Institute

Investigators

Principal Investigator: Neha Sharma, NMP Medical Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NMP Medical Research Institute

ClinicalTrials.gov Identifier:

NCT01460043

Other Study ID Numbers:

NMP-0032-HR

First Posted:

Oct 26, 2011

Last Update Posted:

Nov 10, 2011

Last Verified:

Oct 1, 2011

Additional relevant MeSH terms:

Menorrhagia

Study Results

No Results Posted as of Nov 10, 2011