primary dysmenorrhea with qi-stagnation and blood stasis syndrome
Conditions
Interventions
Sponsors
Hangzhou Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. In line with the diagnosis of primary dysmenorrhea in Western medicine; 2. In line with TCM syndrome differentiation of qi stagnation and blood stasis; 3. In the past 3 months, the VAS score >= 4 points before each menstrual cramp or the most painful day of abdominal pain during menstruation; 4. In the past 3 months, there have been symptoms of dysmenorrhea before or on the day of menstruation; 5. The menstrual cycle is regular, the cycle is 21-35 days, and the menstrual period is 3-7 days; 6. Age 16 to 35 years old (including 16 and 35 years old); 7. Voluntarily participate in this clinical trial, give informed consent and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Painkillers such as non-steroidal anti-inflammatory drugs or other methods of treating dysmenorrhea have been used in the past 1 month; 2. Have used traditional Chinese medicine and Chinese patent medicine with the effect of regulating qi and removing blood stasis in the past 1 month; 3. SCr > upper limit of normal value, ALT or AST >= 1.5 times the upper limit of normal reference value, or hemoglobin <= 90g/L; 4. History of gynecological tumors, uterine fibroids, miscarriage, and gynecological surgery; 5. The use of injection or subcutaneous long-acting contraceptives within 6 months, or the use of contraceptives within 8 weeks, the use of a drug intrauterine device, or the preparation of pregnancy and pregnancy or lactation within six months; 6. There is a tendency to bleeding; 7. Combined with serious primary diseases of the heart, brain, lung, liver, kidney, nervous system and hematopoietic system; 8. Have intellectual disability or mental illness or neurosis; 9. Suspect or have a history of alcohol or drug abuse; 10. Known or suspected to have a history of allergy to the components of the test drug and their excipients; 11. Patients with asthma who are allergic to emergency medication ibuprofen capsules or other non-steroidal anti-inflammatory drugs, or allergic to aspirin; 12. Participated in other clinical trials within the past 3 months; 13. The investigator believes that it is not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS score of the most painful degree of dysmenorrhea;Duration of dysmenorrhea;Dysmenorrhea VAS score time area under curve;Disappearance rate of dysmenorrhea pain;days of obvious pain during menstruation (VAS score>= 4);total CMSs score of dysmenorrhea symptom severity;total CMSs score of dysmenorrhea symptom duration;TCM symptom score;Use of emergency drugs; | — |
Countries
China
Contacts
Public ContactZhang Qin
Hangzhou Hospital of Traditional Chinese Medicine
Outcome results
None listed