A multicenter, randomized, double-blind, dose parallel, placebo-controlled phase II clinical trial to evaluate the efficacy and safety of Jiaweimojie tablet in the treatment of primary dysmenorrhea with qi-stagnation and blood stasis syndrome

Hangzhou Hospital of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

试验速览

暂无简介。

•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.

•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.

发起方

Hangzhou Hospital of Traditional Chinese Medicine