Primary dysmenorrhea
Conditions
Interventions
Treatment group:Gao Mo with Chigao
Sponsors
Jiangsu Province Hospital of TCM
Eligibility
Sex/Gender
Female
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1. Those who meet the diagnostic criteria for primary dysmenorrhea and the TCM syndrome differentiation criteria for qi stagnation and blood stasis. 2. Age between 18 and 35 years old. 3. The menstrual cycle is generally normal (28 ± 7 days). 4. The average VAS pain score in the past three menstrual cycles is = 4cm. 5. Informed consent and voluntary participation. The process of obtaining informed consent should comply with GCP regulations.
Exclusion criteria
Exclusion criteria: 1. Age under 18 years old or over 35 years old. 2. Secondary dysmenorrhea caused by pelvic inflammatory disease, endometriosis, uterine fibroids, or other factors. 3. Irregular menstrual cycle. 4. Traditional Chinese medicine syndrome differentiation does not belong to the Qi stagnation and blood stasis type. 5. MRI contraindications (claustrophobia, pacemaker implantation, or internal surgical metal plates, etc.). 6. Patients with severe primary diseases such as cardiovascular, liver, kidney, digestive system, etc; Disabled patients as defined by law (blind, deaf, mute, intellectually disabled, mentally disabled, physically disabled). Patients who have taken oral prostaglandin synthase inhibitors within 4 weeks prior to enrollment. According to the researcher's judgment, other lesions that may reduce the likelihood of inclusion or complicate inclusion, such as frequent changes in the work environment, can easily lead to loss to follow-up. 9. Allergic constitution, such as a history of allergies to two or more drugs or foods; Or those who are known to be allergic to the ingredients of this medication. 10. Patients who are currently participating in clinical trials of other drugs. 11. Pregnant, preparing for pregnancy or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| COX Dysmenorrhea Symptom Scale;VAS;Evaluation of Traditional Chinese Medicine Syndrome Efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| rs-fMRI;PGF2a; | — |
Countries
China
Contacts
Public ContactZhenkun Xiong
Jiangsu Province Hospital of TCM
Outcome results
None listed