Klimaktoplant H in patients with acute menopausal complaints

Efficacy of Klimaktoplant H in patients with acute menopausal complaints

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16340124

Enrollment

350

Registered

2017-05-09

Start date

2001-04-24

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute menopausal complaints Nutritional, Metabolic, Endocrine Acute menopausal complaints

Interventions

All patients meeting the entry criteria at baseline (day 0) are assigned to one of the two treatment sequences using a predetermined randomisation scheme. Intervention group: Klimaktoplant H (Cimici

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The efficacy of Klimaktoplant H compared to placebo, assessed as change of the total score of the Menopause Rating Scale, is measured using the Menopause Rating Scale at baseline (day 0) and 12 weeks (day 84).	—

Secondary

Measure	Time frame
1. Treatment outcome is measured using the Integrative Medicine Outcomes Scale (IMOS) at day 28, day 58 and day 84 rated by investigator and patients 2. Onset of the effect of investigational medication is measured by the entries in patient’s diary that is used during the treatment period 3. Health status of the patients is measured using the SF-12 Health Survey and EQ-5D questionnaire at baseline (day 0), day 28, day 58 and day 84 4. Satisfaction with treatment is measured using the Integrative Medicine Patient Satisfaction Scale (IMPSS) at day 84	—

Measure

Time frame

1. Treatment outcome is measured using the Integrative Medicine Outcomes Scale (IMOS) at day 28, day 58 and day 84 rated by investigator and patients 2. Onset of the effect of investigational medication is measured by the entries in patient’s diary that is used during the treatment period 3. Health status of the patients is measured using the SF-12 Health Survey and EQ-5D questionnaire at baseline (day 0), day 28, day 58 and day 84 4. Satisfaction with treatment is measured using the Integrative Medicine Patient Satisfaction Scale (IMPSS) at day 84

—

Countries

Ukraine

Contacts

Public ContactJulia Burkart

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026