Condition category
Urological and Genital Diseases
Date applied
19/04/2010
Date assigned
30/04/2010
Last edited
07/11/2013
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

Dr Seong-Gyu Ko

ORCID ID

Contact details

1 Hoegi-dong
Dongdaemun-gu
Seoul
130-701
Korea
South

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CCRG_08_03

Study information

Scientific title

Effects of a Gyejibongnyeong-hwan on dysmenorrhea caused by blood stagnation: a randomized, double-blinded, placebo-controlled, multicenter study

Acronym

Study hypothesis

Gyejibongnyeong-hwan reduces dysmenorrhea caused by blood stagnation more than placebo control.

As of 21/04/2011 the anticipated end date for this trial has been extended from 30/06/2010 to 30/06/2011.

Ethics approval

1. Institutional Review Board (IRB) of Kyung Hee Oriental Medical Center approved on the 18/08/2008 (ref: KOMC IRB 2008-07)
2. IRB of Wonkwang University Sanbon oriental medical center approved on the 24/02/2009 (ref: WONSBHB IRB 2009-02)
3. IRB of Kyungwon Gil Oriental Medical Hospital approved on the 02/02/2009 (ref: 09-101)

Study design

Randomised double-blind parallel group, placebo-controlled trial phase IV study

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 contact details below to request a patient information sheet

Condition

Dysmenorrhea (menstrual pain) caused by blood stagnation

Intervention

Patients will be randomised to receive:
1. Gyejibongnyeong-hwan, a Korean herbal remedy consisting of Cinnamomi ramulus, Poria, Moutan cortex, Persicae semen (peach seed) and Paeoniae radix. 1200 mg/day (400 mg x 3 daily)
2. Placebo control (x 3 daily)
Participants will receive the intervention for approx 8 weeks (two menstrual cycles) and be followed on week 4 and 12 after the end of the treatment. These times will vary depending on the duration of the period/cycle.
Participants will visit six times, screening, visit 1 (week 0), visit 2 (week 4), visit 3 (week 8), visit 4 (week 12), visit 5 (week 20).
The total duration of the trial will be 20 weeks.

Intervention type

Other

Phase

Phase IV

Drug names

Primary outcome measures

Pain, assessed by Visual Analogue Scale (VAS), measured at screening, baseline and weeks 4, 8, 12 and 20

Secondary outcome measures

1. Blood Stagnation Scale (based on Korean Medicine), measured at screening, baseline and weeks 4 and 8
2. Quantity of pain killer pills during period, recorded at screening, baseline and weeks 4, 8, 12 and 20
3. Short Form McGill Pain Questionnaire, measured at screening, baseline and weeks 4, 8, 12 and 20
4. Cox Menstrual Symptom Scale, measured at screening, baseline and weeks 4, 8, 12 and 20
5. Heart rate variability (HRV) outcome, measured at screening, baseline and weeks 4 and 8

Overall trial start date

19/05/2009

Overall trial end date

30/06/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female aged 18 to 35 years
2. Women with a period cycle of 30 ± 3 days during last 3 months
3. Women who have menstrual pain (dysmenorrhea) over 6 degrees by Visual Analogue Scale (VAS)
4. Women who are diagnosed with blood stagnation by two oriental medical gynaecologic specialists
5. Given written informed consent form
6. Given written informed consent form of genetic study

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

100 (50 for each group)

Participant exclusion criteria

1. Women who have major neuro-psychiatric disorder or have history of major neuro-psychiatric disorder (schizophrenia, epilepsy, alcohol abuse, anorexia etc)
2. Women who are planning to have baby or do not agree to use appropriate contraception (oral pill, hormone contraception, intrauterine device, condom etc)
3. Women who are taking anti-depressant, anti-serotonin barbiturate, psychotropic drugs

Recruitment start date

19/05/2009

Recruitment end date

30/06/2011

Locations

Countries of recruitment

Korea, South

Trial participating centre

1 Hoegi-dong
Seoul
130-701
Korea, South

Sponsor information

Organisation

Korea Health Industry Development Institute (South Korea)

Sponsor details

57-1 Noryangjin-dong
Dongjak-gu
Seoul
156-800
Korea
South

Sponsor type

Research organisation

Website

http://www.khidi.or.kr

Funders

Funder type

Research organisation

Funder name

Korea Health Industry Development Institute (South Korea)

Alternative name(s)

KHIDI

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Korea, South

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

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22217258
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/24191165

Publication citations

  1. Protocol

    Park JS, Park S, Cheon CH, Go HY, Sun SH, Shin YC, Jang BH, Ko SG, Effects of Gyejibongnyeong-hwan on dysmenorrhea caused by blood stagnation: study protocol for a randomized controlled trial., Trials, 2012, 13, 3, doi: 10.1186/1745-6215-13-3.

  2. Results

    Park JS, Park S, Cheon CH, Jo SC, Cho HB, Lim EM, Lim HH, Jang BH, Shin YC, Ko SG, Effects and safety of gyejibongnyeong-hwan on dysmenorrhea caused by blood stagnation: a randomized controlled trial., Evid Based Complement Alternat Med, 2013, 2013, 424730, doi: 10.1155/2013/424730.

Additional files

Editorial Notes