Clinical randomized controlled trial of dingkundan oral liquid in the treatment of primary dysmenorrhea
- Conditions
- Primary dysmenorrhea of cold coagulation and blood stasis type
- Registration Number
- ITMCTR2100004709
- Lead Sponsor
- Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- Not specified
1. Patients met the diagnostic criteria of consensus guideline for primary dysmenorrhea of SOGC 2017;
2. According to the syndrome differentiation standard of cold coagulation and blood stasis syndrome;
3. Patients aged between 18 and 30 years who have not given birth (need contraception during medication);
4. The former menstrual cycle was regular (28 ± 7 days);
5. Vas (Visual analog pain score)>= 4;
6. Voluntary informed consent.
1. Secondary dysmenorrhea caused by endometriosis, adenomyosis and pelvic inflammatory disease;
2. Patients who use intrauterine device and plan pregnancy within 6 months;
3. Patients who used long-acting contraceptives by injection or subcutaneous implantation within 6 months, or who took oral contraceptives for less than 8 weeks were in washout period;
4. There are serious primary heart, liver, lung, kidney, blood or other serious diseases affecting survival, such as tumor;
5. Disabled patients stipulated by law (deaf, dumb, blind, mental retardation, spermatic impairment);
6. Suspected or history of drug or alcohol abuse;
7. Allergic weight, allergic to two or more drugs or food, or allergic to known components of the drug;
8. Patients who are participating in clinical trials of other drugs;
9. Patients with other diseases or conditions that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in working environment, unstable living environment, etc., which are likely to cause loss of follow-up.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Degree of abdominal pain during menstruation(VAS score);
- Secondary Outcome Measures
Name Time Method Serum related indexes;Blood flow of bilateral uterine arteries in serum prostaglandins;TCM syndrome integral scale;CMSS scale(Cox dysmenorrhea symptom scale);