Treating Climacteric Symptoms With a Complex Homeopathic Remedy

June 12, 2018 updated by: Cornelia von Hagens, Heidelberg University

Treatment of Climacteric Symptoms With Ovaria Comp - A Prospective Randomized Placebo Controlled Doubleblind Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, D-69115
        • Department of Complementary and Integrative Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group I
ovaria comp 10 Globuli 3 times per day 24 weeks - Placebo 12 weeks
Drug: ovaria comp 10 globuli 3 times per day 24 weeks
order of intervention and placebo varies between Groups I-III
Other Names:
  • placebo globuli 3 times per day 12 weeks
Placebo Comparator: Group II
Placebo 12 weeks - ovaria comp 10 globuli 3 times per day 24 weeks
Drug: ovaria comp 10 globuli 3 times per day 24 weeks
order of intervention and placebo varies between Groups I-III
Other Names:
  • placebo globuli 3 times per day 12 weeks
Placebo Comparator: Group III
ovaria comp 10 globuli 3 times per day 12 weeks - Placebo 12 weeks - ovaria comp 10 globuli 3 times per day 12 weeks
Drug: ovaria comp 10 globuli 3 times per day 24 weeks
order of intervention and placebo varies between Groups I-III
Other Names:
  • placebo globuli 3 times per day 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Climacteric symptoms
Time Frame: 12 weeks
sum score of the menopause rating scale (MRS II) before and after 12 weeks of treatment
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Collaborators

Wala GmbH

Investigators

  • Principal Investigator: Cornelia U von Hagens, MD, Heidelberg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 9, 2005

Study Record Updates

Last Update Posted (Actual)

June 14, 2018

Last Update Submitted That Met QC Criteria

June 12, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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