primary dysmenorrhea
Conditions
Sponsors
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria of RCT: (1) Meet the diagnostic criteria of primary dysmenorrhea, and diagnosis of Qi-stagnation and blood-stasis pattern in Chinese medicine; (2) Aged 18 to 35 years; (3) Menstrual cycle (28 + 7) d; (4) VAS (visual analogue scale) score > 4; (5) Signed informed consent. 2. Inclusion criteria of observational study: (1) Meet the diagnostic criteria of primary dysmenorrhea, and diagnosed as non Qi-stagnation and blood-stasis pattern in Chinese medicine; (2) Aged 18 to 35 years; (3) Menstrual cycle (28 + 7) d; (4) VAS (visual analogue scale) score > 4; (5) Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria of RCT: (1) Secondary dysmenorrhea which was confirmed by ultrasound examination of gynecology and caused by pelvic inflammation, endometriosis, cervix tumor, endometrial polyp and so on; (2) Combined with severe primary diseases of cardiovascular, liver, kidney and blood system and mental illness (those with schizophrenia, epilepsy, alcoholism, anorexia, and/or a history of serious mental illness, and those taking antidepressants, antiserotonin, barbiturates or psychotropic drugs),specially including severe arrhythmia, chronic obstructive pulmonary disease, acute or subacute severe hepatitis, chronic renal failure, diabetes, tumors, schizophrenia and other diseases.; (3) Lactating women and women who are pregnant or are recently prepared for pregnancy; (4) allergies to the drug ingredients in our study; (5) Participants in other clinical trials; (6) Those who have been treated with hormone drugs in the last 3 months; (7) SAS >= 60 or SDS > 62. 2. Exclusion criteria of observational study: (1) Secondary dysmenorrhea which was confirmed by ultrasound examination of gynecology and caused by pelvic inflammation, endometriosis, cervix tumor, endometrial polyp and so on; (2) Lactating women and women who are pregnant or are recently prepared for pregnancy; (3) Participants in other clinical trials; (4) Those who have been treated with hormone drugs in the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change of mean pain intensity ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain duration;perk pain intensity;change of syndrome;The COX menstrual symptom scale (CMSS);EQ-5D-5L;use of painkiller;health economics; | — |
Countries
China
Contacts
Public ContactZehuai Wen
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed