Treating Climacteric Symptoms With a Complex Homeopathic Remedy

Heidelberg University

Status and phase: Completed; Phase 4

Conditions: Menopause; Depression; Anxiety Disorders

Treatments: Drug: ovaria comp 10 globuli 3 times per day 24 weeks

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00152776

HD04

Details and patient eligibility

About

The purpose of this study is to determine whether ovaria comp. is effective in relieving climacteric symptoms.

Full description

Complementary treatments for climacteric symptoms are used by many women although their efficacy and safety is mostly unproven.

The use of the complex homeopathic remedy Ovaria comp. for the relief of climacteric symptoms will be examined in this three-armed intervention trial and measured with the menopause rating scale II before and after each study phase of 12 weeks. Participants will receive the verum during two treatment phases of 12 weeks and the placebo during one treatment phase of 12 weeks in different sequences and are stratified for post- and perimenopausal status.

Enrollment: 102 patients

Sex: Female

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Climacteric symptoms>=3 Points in Menopause Rating Scale (MRS) II
• Communication possible

Exclusion criteria

• Hormone replacement therapy within 2 weeks prior to study inclusion
• Other complementary treatments 7 days before and during the study
• Climacteric symptoms caused by operation, chemotherapy or hormonal therapy of cancer
• Allergy to components of the remedy, especially bee poison

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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102 participants in 3 patient groups, including a placebo group

Group I

Placebo Comparator group

Description:

ovaria comp 10 Globuli 3 times per day 24 weeks - Placebo 12 weeks

Treatment:

Drug: ovaria comp 10 globuli 3 times per day 24 weeks

Group II

Placebo Comparator group

Description:

Placebo 12 weeks - ovaria comp 10 globuli 3 times per day 24 weeks

Treatment:

Drug: ovaria comp 10 globuli 3 times per day 24 weeks

Group III

Placebo Comparator group

Description:

ovaria comp 10 globuli 3 times per day 12 weeks - Placebo 12 weeks - ovaria comp 10 globuli 3 times per day 12 weeks

Treatment:

Drug: ovaria comp 10 globuli 3 times per day 24 weeks