ITMCTR1900002773RecruitingPhase 1
A randomized controlled trial for Yi-Sheng Xiao-Zheng granules in the treatment of dysmenorrhea caused by pelvic endometriosis (syndrome of kidney deficiency and blood stasis)
Dongfang Hospital of Beijing University of Chinese Medicine0 sitesStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional study
Eligibility Criteria
- Ages
- 20 to 45 (—)
- Sex
- Female
Inclusion Criteria
- •1. diagnosis of pelvic endometriosis;
- •2. dysmenorrhea symptom score >=7.5 points;
- •3. syndrome differentiation of traditional Chinese medicine for kidney deficiency and blood stasis;
- •4. aged 20-45 years (including 20 and 45 years);
- •5. voluntary signing of informed consent;
- •6. Those who sign informed consent voluntarily.
Exclusion Criteria
- •(1) Patients with ovarian cancer, pelvic inflammatory mass, adenomyosis, uterine fibroids>4cm, primary dysmenorrhea, or intrauterine contraceptive device;
- •(2) Those who have recieved the treatment of endometriosis drugs or other therapies (including laparoscopic) in the last 3 months;
- •(3) Ovarian chocolate cyst diameter>5cm;
- •(4) Hemoglobin<90g/L;
- •(5) Patients with severe cardiovascular diseases and liver diseases: ALT and AST are higher than normal, kidney diseases;BUN and Scr are higher than normal;
- •(6)Allergy or allergy to this experimental drug;
- •(7) Pregnancy, lactation women, or the near future pregnancy plan, can not ensure that during the use of drugs and drug use after the end of a month to take effective contraceptive measures of patients;
- •(8) People who suffer from any serious psychological and mental abnormalities and cannot follow the procedures and norms of clinical trials;
- •(9) Patients whom the doctor deems unfit to participate in clinical trials;
- •(10) Patients who use ibuprofen with caution, including gastrointestinal diseases, including renal insufficiency, high blood pressure, cardiac insufficiency, gastrointestinal ulcers, hemophilia or other hemorrhagic diseases (including coagulation or platelet dysfunction) and bronchial asthma.
Investigators
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