Treating Climacteric Symptoms With a Complex Homeopathic Remedy

Phase 4

Completed

• Conditions: Menopause; Anxiety Disorders; Depression
• Interventions: Drug: ovaria comp 10 globuli 3 times per day 24 weeks

• Registration Number: NCT00152776
• Lead Sponsor: Heidelberg University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-09
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-12
• Last Update Posted: 2018-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group I	ovaria comp 10 globuli 3 times per day 24 weeks	ovaria comp 10 Globuli 3 times per day 24 weeks - Placebo 12 weeks
Group II	ovaria comp 10 globuli 3 times per day 24 weeks	Placebo 12 weeks - ovaria comp 10 globuli 3 times per day 24 weeks
Group III	ovaria comp 10 globuli 3 times per day 24 weeks	ovaria comp 10 globuli 3 times per day 12 weeks - Placebo 12 weeks - ovaria comp 10 globuli 3 times per day 12 weeks

Primary Outcome Measures

Name	Time	Method
Climacteric symptoms	12 weeks	sum score of the menopause rating scale (MRS II) before and after 12 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Climacteric symptoms (vegetative, psychological, urogenital subscales of the MRS II)	12 weeks	difference of the subscales of the menopause rating scale before and after 12 weeks of treatment
Follow-up for another 12 weeks of treatment or after cross-over to the placebo group	12+12 weeks	sum score and subscales of the MRS II
Follow-up for cross-over to placebo after 24 weeks of treatment	12+12+12 weeks	sum score and subscales of the MRS II
Diurnal profile of cortisol level before and after treatment phases	12+12+12 weeks	cortisol (saliva: morning, noon, evening)
Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS-D) before and after treatment period	12+12+12 weeks	Hospital Anxiety and Depression Scale

Trial Locations

Locations (1)

Department of Complementary and Integrative Medicine; 🇩🇪 Heidelberg, Baden-Württemberg, Germany