None listed
Conditions
Interventions
Drug : Participants will administer DJS, GSS, or placebo powder orally three times a day for two menstrual cycles according to the group allocated
Sponsors
Kyung Hee University Oriental Medicine Hospital at Gangdong
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: The inclusion criteria are: (1) reproductive-age female aged = 18 and = 40 years; (2) suffering from primary dysmenorrhea; (3) suffering from menstrual pain within recent three consecutive months and average VAS = 50 mm during run-in period; (4) being provided with the details of this trial, understanding the details completely, willing to participate voluntarily, and being offered written informed consent to follow the precautions.
Exclusion criteria
Exclusion criteria: The exclusion criteria are: (1) women suffering from secondary dysmenorrhea due to pelvic pathology such as uterine fibroids, adenomyosis, endometriosis, or pelvic inflammatory diseases; (2) lactating, being pregnancy, intend to be pregnant, or have possibility of pregnancy (human chorionic gonadotropin test positive); (3) with intrauterine devices; (4) metrorrhagia with menstrual cycles less than 21 days or oligomenorrhea with cycles over 40 days; (5) have administered oral contraceptives or other hormonal treatments within recent three months; (6) twice higher liver enzymes (alanine transaminase or aspartate transaminase) than the reference values of study sites; (7) 1.5 times higher blood urea nitrogen or creatinine than the reference values of study sites; (8) have depressive or anxiety disorders, or administrating psychiatric medications such as antidepressants; (9) have participated in other clinical trials within recent one month; (10) have been treated with Chinese herbal medicines or alternative therapies for primary dysmenorrhea within recent three months; (11) judged inadequate by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS(Visual analogye scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| VMSS(Verbal multidimensional scoring system);RSS(Retrospective symptom scale);Short form McGill pain questionnaire (SF-MPQ);pattern diagnosis questionaaire(Qi stagnation pattern, Blood stasis pattern);short form 36 health survey (SF-36);adverse event;vital sign;laboratory test;EuroQol Rive dimesions Questionnaire(EQ-5D);iMTA Productivity Cost Questionnaire(iPCQ) | — |
Countries
Korea, Republic of
Contacts
Public ContactEun Jeong Jeong
Kyung Hee University Oriental Medicine Hospital at Gangdong
Outcome results
None listed