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
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
-
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.
-
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.