A prospective, randomized, double-blind, multicenter clinical study of Neiyifang in the treatment of congealing cold blood stasis of endometriosis
- Conditions
- endometriosis
- Registration Number
- ITMCTR2200005646
- Lead Sponsor
- Shanghai Changhai Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- Not specified
? All cases should meet EM clinical diagnostic criteria and TCM diagnostic criteria of congealing cold blood stasis syndrome;
? 18-40 years old;
? Menstrual cycle between 21 and 35 days, period of 3 to 7 days;
(4) VAS score =3, and pain must be continuous or recurrent for at least 6 months;
? Those who voluntarily participated in the experiment and signed the informed consent;
? Those who have not been treated with Western medicine or have been treated with western medicine but have stopped taking medicine for 3 months.
1) patients with adenomyosis;
2) Patients with serious diseases such as cardiovascular, cerebrovascular, liver, kidney, diabetes and tumor;
3) Mental illness and long-term alcohol or drug use affect cognition;
4) Patients with chronic pelvic pain caused by anxiety and depression (depression scale and anxiety scale =50 points). (Less than 50 on the SELF-rated Anxiety scale/Self-rated Depression scale was considered normal; A score of 50-60 was mild anxiety; A score of 61 to 70 indicates moderate anxiety, while a score of 70 or more indicates severe anxiety.)
5) Long-term use of painkillers or overuse of painkillers (more than 10 days in a month);
6) Suspected or confirmed history of smoking, alcohol and drug abuse;
7) Women who have positive pregnancy test, are pregnant or breast-feeding, or plan to have a pregnancy;
8) allergic constitution and known allergic to the composition of the drug;
9) Participants in other clinical trials or participants in clinical trials within 3 months prior to screening;
10) Patients with coagulation dysfunction and previous thrombotic diseases;
11) Those who are considered unsuitable for the clinical trial by the investigator.
Study & Design
- Study Type
- Treatment study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method remission rate of EAPP;
- Secondary Outcome Measures
Name Time Method CA125;TCM syndrome score;COX-Menstrual symptom score;VAS, DYS, NMPP of EAPP;EHP-5;