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Effects of herbal medicine for dysmenorrhea treatment on accompanied acne vulgaris: double-blind, randomized, parallel-group, multi-center trial

Effects of herbal medicine for dysmenorrhea treatment on accompanied acne vulgaris: double-blind, randomized, parallel-group, multi-center trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0002259
Enrollment
116
Registered
2017-03-10
Start date
2017-02-23
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

None listed

Interventions

Drug : Experimental group will be administered gyejibokryung-hwan and dangguijagyag-san according to the Excess-Deficiency syndrome differentiation. Excess syndrome group for dysmenorrhea will be oral

Sponsors

Kyung Hee University Oriental Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women aged over 19 years and in childbearing age 2. Patients who have more than 10 inflammatory acne lesion on their face 3. Patients who have menstrual pain more than grade 1 according to the verbal multidimensional scoring system 4. Patients who have regular menstrual cycle from 23 days to 33 days within 3 months 5. Patients who deteriorate acne vulgaris related to the menstrual cycle 6. Patients who don’t have any problems for expressing their thoughts 7. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients who taken following medicine ? Topical or systemic corticosteroids (within 1 month) ? Herbal medicine for acne treatment (within 1 month) ? Nonsteroidal antiinflammatory drugs (NSAIDs) (within 2 weeks) ? Oral contraceptives (within 1 month) ? Topical or oral vitamin A derivatives (within 1 month) ? Antibiotics (within 1 month) ? Other unstable drugs as judged by the investigators 2. Body Mass Index (BMI) <19 or BMI = 25 3. Liver function abnormality (Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)=60IU/L) or renal function abnormality (blood urea nitrogen (BUN)=30mg/dL or a serum creatinine levels = 1.5mg/dL) 4. Pregnancy or breastfeeding or having plan to be pregnant or having possibility for pregnancy 5. Patients who have malignant tumor, serious infection or severe systemic diseases 6. Patients who attended to other clinical trials during previous 3 months 7. unsuitability as judged by the investigators

Design outcomes

Primary

MeasureTime frame
mean percentage change of total acne lesion counts

Secondary

MeasureTime frame
Numeric Rating Scale(NRS) score for menstrual pain;verbal multidimensional scoring system (VMSS) score for menstrual pain ;inflammatory acne lesion counts;non-inflammatory acne lesion counts;Safety outcome(liver function test and renal function test);Blood test (serum total testosterone, serum dehydroepiandrosteron-sulfate(DHEA-S), luteinizing hormone (LH)/ follicle-stimulating hormone (FSH) ratio )

Countries

Korea, Republic of

Contacts

Public ContactKwan-Il Kim

Kyung Hee University Oriental Medical Center

myhappy78@naver.com+82-2-958-9279

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Mar 9, 2026