MedPath

Klimaktoplant H in patients with acute menopausal complaints

Phase 3
Completed
Conditions
Acute menopausal complaints
Nutritional, Metabolic, Endocrine
Registration Number
ISRCTN16340124
Lead Sponsor
Deutsche Homöopathie-Union (DHU)-Arzneimittel GmbH & Co. KG
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Female
Target Recruitment
350
Inclusion Criteria

1. Age 40–55 years
2. Acute menopausal complaints in the pre-, peri- and early postmenopausal period
3. Total score of the Menopause Rating Scale = 20 points and at least severe complaints concerning the symptom hot flushes, sweating
4. Female

Exclusion Criteria

1. Menopause is longer than 3 years ago
2. Forced indication for hormonal replacement therapy (e.g. surgical menopause, manifest osteoporosis)
3. Hormonal replacement therapy in the last 6 months before enrolment into the trial and/or treatment with herbal or homeopathic medication in the last 3 months before enrolment into the trial
4. Concomitant medications, that might impair the trial result (e.g. hormones, centrally effective antihypertensive agents, other therapies of menopausal complaints)
5. Known or supposed hypersensitivity against trial medication
6. Severe concomitant diseases, e.g. heart and liver diseases, and/or immune suppression or multimorbidity
7. Known alcohol or drug abuse
8. Have taken part in another clinical trial during the last 6 months
9. Irresponsible patients or patients unable to understand nature, meaning and consequences of the trial

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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