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

Phase 2

Recruiting

• Conditions: primary dysmenorrhea with qi-stagnation and blood stasis syndrome

• Registration Number: ITMCTR2100005170
• Lead Sponsor: Hangzhou Hospital of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TCM symptom score;total CMSs score of dysmenorrhea symptom severity;Dysmenorrhea VAS score time area under curve;Use of emergency drugs;VAS score of the most painful degree of dysmenorrhea;total CMSs score of dysmenorrhea symptom duration;Duration of dysmenorrhea;Disappearance rate of dysmenorrhea pain;days of obvious pain during menstruation (VAS score>= 4);