Klimaktoplant H in patients with acute menopausal complaints

• Register: ISRCTN
• Last refreshed on: 21 August 2017
• Main ID: ISRCTN16340124
• Date of registration: 09/05/2017
• Prospective Registration: No
• Primary sponsor: Deutsche Homöopathie-Union (DHU)-Arzneimittel GmbH & Co. KG
• Public title: Klimaktoplant H in patients with acute menopausal complaints
• Scientific title: Efficacy of Klimaktoplant H in patients with acute menopausal complaints
• Date of first enrolment: 24/04/2001
• Target sample size: 350
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN16340124
• Study type: Interventional
• Study design: Multi-centre prospective randomized double-blind placebo controlled phase III trial (Treatment)
• Phase: Phase III

Countries of recruitment

Ukraine

Contacts

• Name: Julia Burkart

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Acute menopausal complaints
Nutritional, Metabolic, Endocrine
Acute menopausal complaints

Intervention(s)

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 (Cimicifuga D2, Sepia D2, Sanguinaria D2, Ignatia D3) treatment starts immediately after the baseline visit (day 0) and continues for 12 weeks. Two tablets are taken orally three times a day. There is no run-in period, where patients are monitored before they receive Klimaktoplant H.

Control group: Placebo treatment startd immediately after the baseline visit (day 0) and continued for 12 weeks. Two tablets are taken orally three times a day. There is no run-in period, where patients are monitored before they receive Placebo.

All patients were followed for 12 weeks in total.

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

KP 004

Source(s) of Monetary Support

Deutsche Homöopathie-Union (DHU)-Arzneimittel GmbH & Co. KG