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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN30426947
Enrollment
100
Registered
2010-04-30
Start date
2009-05-19
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysmenorrhea (menstrual pain) caused by blood stagnation Urological and Genital Diseases Pain and other conditions associated with female genital organs and menstrual cycle

Interventions

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/

Sponsors

Korea Health Industry Development Institute (South Korea)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

Korea, South

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 27, 2026