Effects of herbal medicine for dysmenorrhea treatment on accompanied acne vulgaris: double-blind, randomized, parallel-group, multi-center trial
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0002259
- Lead Sponsor
- Kyung Hee University Oriental Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 116
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method mean percentage change of total acne lesion counts
- Secondary Outcome Measures
Name Time Method umeric 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 )