Condition category
Urological and Genital Diseases
Date applied
09/09/2008
Date assigned
18/09/2008
Last edited
18/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Kun Hyung Kim

ORCID ID

Contact details

Department of Medical Research
Korea Institute of Oriental Medicine
483 Expo-ro
Yuseong-gu
Daejeon
305811
Korea
South
+82 (0)42 868 9269
pdchrist@kiom.re.kr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KE0801

Study information

Scientific title

Acronym

Study hypothesis

Acupuncture could reduce the frequency and severity of hot flushes and alleviate menopausal symptoms in peri-menopausal and post-menopausal women.

Ethics approval

1. The Research Ethics Board of Dongguk International Hospital on 2nd July 2008
2. East-West Neo Medical Centre, Kyung Hee University on 17th June 2008
3. Dong Eui Medical Centre, Dong Eui University on 5th June 2008
4. Semyung University Hospital on 10th June 2008

Study design

Multicentre randomised controlled trial with two parallel arms

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

Hot flushes

Intervention

Arm A : Standardised traditional korean acupuncture plus usual care
Arm B : Usual care alone

Arm A receives acupuncture 3 times/week, total 12 sessions for 4 weeks, and will be followed up 4 weeks after finishing acupuncture treatment. Total duration will be 8 weeks (4 weeks treatment plus 4 weeks follow up).

Arm B receives no acupuncture treatments during 4 weeks. After 4 weeks, if they want to take the acupuncture treatment, the same treatment will be provided. But we will not use this data for the current trial. Total duration will be 4 weeks (4 weeks usual care alone).

Both groups maintain usual care during the trial. Use of over-the-counter (OTC) drugs for managing usual symptoms like episodic colds, headaches and dyspepsia, and of some supplements for self-care on menopausal symptoms will be permitted as usual care. All participants will be asked to notice any other attempts of receiving new treatments or cares for their health condition before employing them to avoid the protocol violation.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Hot flush score: calculated by multiplying daily frequency and severity (0 : none, 1: mild, 2: moderate, 3: severe, 4: very severe) of hot flushes. Frequency and severity of hot flushes will be derived from self-reported daily logs, and data will be collected every 1 week. Participants are required to fill the diary during the treatment and follow-up phases.

Secondary outcome measures

Menopause Rating Scale (MRS): measured at baseline, 2 and 4 weeks after randomisation in both group. Additional measure at 6 and 8 weeks after randomisation will be conducted in Arm A during follow-up phase.

Overall trial start date

15/06/2008

Overall trial end date

01/11/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Peri-menopausal or post-menopausal women within 45 and 60 years old
2. Average daily hot flush scores greater than 10 for last one week at screening visit

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

180

Participant exclusion criteria

1. Participants under serious medical conditions (like uncontrolled hypertension, diabetes mellitus needed to be controlled by insulin injection, etc.)
2. Any type of thyroid dysfunction
3. History of past or current malignant tumour
4. Severe dyslipidaemia
5. Other infectious diseases or systemic diseases which is inadequate for acupuncture treatment
6. Use of any hormones, antidepressants, gabapentin, selective serotonin reuptake inhibitor (SSRI) and sedatives
7. Use of black cohosh and human placenta extracts
8. Any additional acupuncture treatment, herb prescription, therapeutic performance by other traditional Korean medicine (TKM) doctor during the study
9. Night-workers

Recruitment start date

15/06/2008

Recruitment end date

01/11/2008

Locations

Countries of recruitment

Korea, South

Trial participating centre

Department of Medical Research
Daejeon
305811
Korea, South

Sponsor information

Organisation

Korea Institute of Oriental Medicine (South Korea)

Sponsor details

c/o Sun-Mi Choi
483 Expo-ro
Yuseong-gu
Daejeon
305811
Korea
South
+82 (0)42 868 9485
smchoi@kiom.re.kr

Sponsor type

Research organisation

Website

http://www.kiom.re.kr/index.jsp

Funders

Funder type

Research organisation

Funder name

Korea Institute of Oriental Medicine (South Korea) - Acupuncture, Moxibustion and Meridian Research Project (ref: K08010)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes