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Trial of Homeopathy on Management of Menorrhagia

NCT ID: NCT01460043

Last Updated: 2011-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-06-30

Brief Summary

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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

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Conditions

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Menorrhagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Homeopathy

Individualized symptom based therapy

Group Type EXPERIMENTAL

Homeopathy

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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NMP Medical Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neha Sharma

Role: PRINCIPAL_INVESTIGATOR

NMP Medical Research Institute

Other Identifiers

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NMP-0032-HR

Identifier Type: -

Identifier Source: org_study_id