Effects of a Gyejibongnyeong-hwan on dysmenorrhea caused by blood stagnation
| ISRCTN | ISRCTN30426947 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30426947 |
| Secondary identifying numbers | CCRG_08_03 |
- 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
Scientific
1 Hoegi-dong
Dongdaemun-gu
Seoul
130-701
Korea, South
Study information
| Study design | Randomised double-blind parallel group, placebo-controlled trial phase IV study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 | 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 study start date | 19/05/2009 |
| Completion date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 100 (50 for each group) |
| 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
130-701
Korea, South
Sponsor information
Korea Health Industry Development Institute (South Korea)
Research organisation
Research organisation
57-1 Noryangjin-dong
Dongjak-gu
Seoul
156-800
Korea, South
| Website | http://www.khidi.or.kr |
|---|---|
"ROR" |
https://ror.org/00fdzyk40 |
Funders
Funder type
Research organisation
Korea Health Industry Development Institute (South Korea)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- KHIDI
- Location
- Korea, South
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 05/01/2012 | Yes | No | |
| Results article | results | 01/01/2013 | Yes | No |
