Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/04/2017
Date assigned
09/05/2017
Last edited
12/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The menopause is when a woman stops having periods and is no longer able to get pregnant naturally. This is a natural part of the aging process that usually happens when a women is around 50 years old. At this time, a woman’s oestrogen (female hormone) levels decline, leading to a range of symptoms, including hot flushes, sleep disturbances, and mood swings. There is a lot of evidence showing that the decline in oestrogen can be linked with an increased risk of heart disease and osteoporosis (brittle bones). One way of preventing this is by taking medication to replace the depleted osetrogen (hormone replacement), however this is unpopular. Klimaktoplant H is a medication used to treat menopausal symptoms without use of hormones. The aim of this study is to find out if taking Klimaktoplant H is an effective way of reducing menopausal symptoms.

Who can participate?
Women aged 40-55 years who are going through the menopause.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take two tablets containing Klimaktoplant H three times a day for 12 weeks. Those in the second group two tablets containing a placebo (dummy drug) three times a day for 12 weeks. Over the 12 weeks of the study, participants in both groups are regularly assessed in order to find out whether the Klimaktoplant H has had any effect on menopause symptoms.

What are the possible benefits and risks of participating?
Participants who are treated with Klimaktoplant H may benefit from a reduction in their menopausal symptoms. There is a risk for those taking Klimaktoplant H of side effects, such as allergic reactions, nosebleeds, and restarting menstrual bleeding.

Where is the study run from?
Six medical practices in Kiev (Ukraine)

When is the study starting and how long is it expected to run for?
December 2000 to January 2004

Who is funding the study?
Deutsche Homöopathie-Union (DHU)-Arzneimittel GmbH & Co. KG (Germany)

Who is the main contact?
Ms Julia Burkart

Trial website

Contact information

Type

Public

Primary contact

Ms Julia Burkart

ORCID ID

Contact details

Deutsche Homöopathie-Union (DHU)-Arzneimittel GmbH & Co. KG
Ottostraße 24
Karlsruhe
76227
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KP 004

Study information

Scientific title

Efficacy of Klimaktoplant H in patients with acute menopausal complaints

Acronym

Study hypothesis

The aim of this study is to evaluate the efficacy and safety of Klimaktoplant H compared to placebo in patients with acute menopausal complaints.

Ethics approval

The Ethics Committee of the State Pharmacological Center of the Ministry of Health of Ukraine, 13/03/2001, ref: 5.12-91/KE

Study design

Multi-centre prospective randomized double-blind placebo controlled phase III trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Acute menopausal complaints

Intervention

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.

Intervention type

Drug

Phase

Phase III

Drug names

Klimaktoplant H

Primary outcome measures

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 measures

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

Overall trial start date

20/12/2000

Overall trial end date

30/01/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

350

Participant 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

Recruitment start date

24/04/2001

Recruitment end date

26/11/2002

Locations

Countries of recruitment

Ukraine

Trial participating centre

Faculty No 1 of Obestrics and Gynecology of the National Medical University A.A. Bogomolets
Shavchenko Avenue 17
Kiev
01004
Ukraine

Trial participating centre

Pregnant consultation hour No 1 of the medical district area of Radianskiy region
Zoologicheskaya Street 3
Kiev
01004
Ukraine

Trial participating centre

Pregnant consultation hour No 3 of the medical district area of Radianskiy region
Bogdana Khmelnitskogo Street 37
Kiev
01000
Ukraine

Trial participating centre

Pregnant consultation hour No 1 of the medical district area of Leningradskiy region
Kuchera Street 7
Kiev
01000
Ukraine

Trial participating centre

Pregnant consultation hour No 3 of the 1st adult polyclinic of the medical district area of Dneprovskiy region
Petra Zaporozhtsa 17
Kiev
01000
Ukraine

Trial participating centre

Pregnant consultation hour for obestrics No 4 of the medical district of Minskiy region
Geroev Stalingrada 16
Kiev
01210
Ukraine

Sponsor information

Organisation

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

Sponsor details

Ottostraße 24
Karlsruhe
76227
Germany

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

There are no plans for publication.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study is not expected to be made available due to ethical reasons, participant confidentiality and in terms of other data protection law.

Intention to publish date

01/01/1900

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/07/2017: Internal edit.