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Treating Climacteric Symptoms With a Complex Homeopathic Remedy

Primary Purpose

Menopause, Anxiety Disorders, Depression

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
ovaria comp 10 globuli 3 times per day 24 weeks
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menopause focused on measuring menopausal symptoms, complementary medicine

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Department of Complementary and Integrative Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Group I

Group II

Group III

Arm Description

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

Placebo 12 weeks - 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 8, 2005
Last Updated
June 12, 2018
Sponsor
Heidelberg University
Collaborators
Wala GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00152776
Brief Title
Treating Climacteric Symptoms With a Complex Homeopathic Remedy
Official Title
Treatment of Climacteric Symptoms With Ovaria Comp - A Prospective Randomized Placebo Controlled Doubleblind Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
Collaborators
Wala GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause, Anxiety Disorders, Depression
Keywords
menopausal symptoms, complementary medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Placebo Comparator
Arm Description
ovaria comp 10 Globuli 3 times per day 24 weeks - Placebo 12 weeks
Arm Title
Group II
Arm Type
Placebo Comparator
Arm Description
Placebo 12 weeks - ovaria comp 10 globuli 3 times per day 24 weeks
Arm Title
Group III
Arm Type
Placebo Comparator
Arm Description
ovaria comp 10 globuli 3 times per day 12 weeks - Placebo 12 weeks - ovaria comp 10 globuli 3 times per day 12 weeks
Intervention Type
Drug
Intervention Name(s)
ovaria comp 10 globuli 3 times per day 24 weeks
Other Intervention Name(s)
placebo globuli 3 times per day 12 weeks
Intervention Description
order of intervention and placebo varies between Groups I-III
Primary Outcome Measure Information:
Title
Climacteric symptoms
Description
sum score of the menopause rating scale (MRS II) before and after 12 weeks of treatment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Climacteric symptoms (vegetative, psychological, urogenital subscales of the MRS II)
Description
difference of the subscales of the menopause rating scale before and after 12 weeks of treatment
Time Frame
12 weeks
Title
Follow-up for another 12 weeks of treatment or after cross-over to the placebo group
Description
sum score and subscales of the MRS II
Time Frame
12+12 weeks
Title
Follow-up for cross-over to placebo after 24 weeks of treatment
Description
sum score and subscales of the MRS II
Time Frame
12+12+12 weeks
Title
Diurnal profile of cortisol level before and after treatment phases
Description
cortisol (saliva: morning, noon, evening)
Time Frame
12+12+12 weeks
Title
Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS-D) before and after treatment period
Description
Hospital Anxiety and Depression Scale
Time Frame
12+12+12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cornelia U von Hagens, MD
Organizational Affiliation
Heidelberg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Complementary and Integrative Medicine
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
D-69115
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22017387
Citation
von Hagens C, Schiller P, Godbillon B, Osburg J, Klose C, Limprecht R, Strowitzki T. Treating menopausal symptoms with a complex remedy or placebo: a randomized controlled trial. Climacteric. 2012 Aug;15(4):358-67. doi: 10.3109/13697137.2011.597895. Epub 2011 Oct 23.
Results Reference
result

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Treating Climacteric Symptoms With a Complex Homeopathic Remedy

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