Effects of a Gyejibongnyeong-hwan on dysmenorrhea caused by blood stagnation

ISRCTN	ISRCTN30426947
DOI	https://doi.org/10.1186/ISRCTN30426947
Protocol serial number	CCRG_08_03
Sponsor	Korea Health Industry Development Institute (South Korea)
Funder	Korea Health Industry Development Institute (South Korea)

Submission date: 19/04/2010
Registration date: 30/04/2010
Last edited: 07/11/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Seong-Gyu Ko
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised double-blind parallel group, placebo-controlled trial phase IV study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effects of a Gyejibongnyeong-hwan on dysmenorrhea caused by blood stagnation: a randomized, double-blinded, placebo-controlled, multicenter study
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Pain, assessed by Visual Analogue Scale (VAS), measured at screening, baseline and weeks 4, 8, 12 and 20
Key secondary outcome measure(s)	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
Completion date	30/06/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	100
Key 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
Key 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
Date of first enrolment	19/05/2009
Date of final enrolment	30/06/2011

Locations

Countries of recruitment

Korea, South

Study participating centre

1 Hoegi-dong

Seoul
130-701
Korea, South

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2013		Yes	No
Protocol article	protocol	05/01/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes