Trial of Homeopathy on Management of 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.

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Key information

Conditions

Menorrhagia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

35 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Homeopathy

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.

Placebo

Drug

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

Primary outcomes

daily assessment of bleeding

Time frame: 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 outcomes

Health related quality of life

Time frame: change from baseline over 3 months

Sponsors and collaborators

Lead sponsor

NMP Medical Research Institute

Other

Registry information

Official study title

Pilot Study of Homeopathy in Dysfunctional Uterine Bleeding Presenting as Menorrhagia

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Oct 26, 2011
Registry last updated: Nov 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed