ITMCTR2100005002招募中2 期
Golden grass piece of treatment of pelvic inflammatory disease sequelae of chronic pelvic pain efficacy and safety of multicenter, randomized, double-blind, parallel-group dose, placebo-controlled phase II trial
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University0 个研究点开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 55（—）
- 性别
- Female
入选标准
- •(1) It meets the diagnostic criteria of chronic pelvic pain in the sequelae of pelvic inflammatory diseases;
- •(2) The average score of pain VAS in the week before inclusion >=4;
- •(3) At the time of enrollment, the MC Cormack Scale scored 4-12 points (including 4 points and 12 points);
- •(4) Female aged 18 to 55 years (including 18 and 55 years), who have a sexual life history;
- •(5) Volunteered to participate in this clinical trial, informed consent and signed informed consent.
排除标准
- •(1) Pelvic inflammatory disease (acute attack);
- •(2) pregnant and lactating women who are unwilling to take effective measures to prevent pregnancy during the trial and within 3 months after the end of the trial;
- •(3) Critical condition or indications of operation, such as complicated with diffuse peritonitis and sepsis;
- •(4) Chronic pelvic pain caused by cervical intraepithelial neoplasia, primary/secondary dysmenorrhea, pelvic stasis syndrome and other non-pelvic inflammatory diseases have been clearly diagnosed in the past;
- •(5) Specific vaginitis, such as vulvovaginal candidiasis, trichomoniasis vaginitis and bacterial vaginosis, were complicated at the time of enrollment;
- •(6) Gynecological tumors (uterine fibroids with maximum diameter greater than 3cm and submucosal fibroids), endometriosis, myoadenosis, acute cervicitis, tuberculous pelvic inflammatory disease, interstitial cystitis and other diseases caused by related symptoms;
- •(7) IUD was placed in the last 3 months; Absence of uterus and bilateral appendages;
- •(8) Have received relevant treatment or taken drugs with similar functions within 14 days before introduction;
- •(9) Liver function index (ALT, AST) >=1.5 ULN, and renal function index SCR >=1 ULN;
- •(10) Serum CA125 and erythrocyte sedimentation rate >=1.5 ULN;
- •(11) Routine blood indicators (RBC, WBC, HB, PLT) >=1.5 ULN; Fasting blood glucose exceeded the upper limit of the normal reference value; Twelve lead electrocardiogram showed abnormal QT interval
- •(12) Complicated with serious cardiovascular, cerebrovascular, hematopoietic system and other serious diseases;
- •(13) Have a history of allergy to test drug ingredients;
- •(14) A history of long-term alcohol and drug abuse;
- •(15) having intellectual or mental retardation;
- •(16) Participated in other clinical trials within the last 3 months;
- •(17)The investigator did not consider it appropriate to participate in this clinical trial.
研究者
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