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Treating Climacteric Symptoms With a Complex Homeopathic Remedy

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ClinicalTrials.gov Identifier: NCT00152776
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : June 14, 2018
Sponsor:
Collaborator:
Wala GmbH
Information provided by (Responsible Party):
Cornelia von Hagens, Heidelberg University

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

Condition or disease Intervention/treatment Phase
Menopause Anxiety Disorders Depression Drug: ovaria comp 10 globuli 3 times per day 24 weeks Phase 4

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  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Climacteric Symptoms With Ovaria Comp - A Prospective Randomized Placebo Controlled Doubleblind Study
Study Start Date : February 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Menopause

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 Name: 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 Name: 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 Name: placebo globuli 3 times per day 12 weeks




Primary Outcome Measures :
  1. Climacteric symptoms [ Time Frame: 12 weeks ]
    sum score of the menopause rating scale (MRS II) before and after 12 weeks of treatment


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Diurnal profile of cortisol level before and after treatment phases [ Time Frame: 12+12+12 weeks ]
    cortisol (saliva: morning, noon, evening)

  5. 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



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00152776


Locations
Germany
Department of Complementary and Integrative Medicine
Heidelberg, Baden-Württemberg, Germany, D-69115
Sponsors and Collaborators
Heidelberg University
Wala GmbH
Investigators
Principal Investigator: Cornelia U von Hagens, MD Heidelberg University

Publications of Results:
Responsible Party: Cornelia von Hagens, Principal Investigator, Heidelberg University
ClinicalTrials.gov Identifier: NCT00152776     History of Changes
Other Study ID Numbers: HD04
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018

Keywords provided by Cornelia von Hagens, Heidelberg University:
menopausal symptoms
complementary medicine

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders