A Study of Jincaopian Tablets on Chronic Pelvic Pain After Pelvic Inflammatory Disease

Launched by BEIJING KONRUNS PHARMACEUTICAL CO., LTD. · Jul 29, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Jincaopian Tablets to see how effective and safe it is for women suffering from chronic pelvic pain caused by pelvic inflammatory disease (PID). Chronic pelvic pain is a long-lasting pain in the lower abdomen that can occur after PID, which is an infection of the female reproductive organs. The trial is currently looking for women aged 18 to 50 who have been experiencing this type of pain, with a pain score of 4 or higher on a scale from 0 to 10. Participants should also have a certain level of physical signs indicating pain.

Women who are pregnant, breastfeeding, or have certain other medical conditions will not be eligible to participate. If you decide to join this trial, you can expect to take the Jincaopian Tablets over a period of time and attend regular check-ups to monitor your health and pain levels. It’s important to know that this study aims to improve treatment options for chronic pelvic pain, and your participation could help advance medical knowledge in this area. If you think you might qualify and are interested, please talk to your doctor for more details.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Meet the diagnostic criteria for chronic pelvic pain sequelae of pelvic inflammatory disease;
• • The average VAS score of pain in the week before enrollment is ≥4;
• • The McCormack scale of physical signs at the time of enrollment is 4 to 12 points (including 4 points and 12 points);
• • Women aged 18 to 50 (including 18 and 50) with a history of sexual life;
• • Voluntarily participate in this clinical trial, give informed consent and sign the informed consent form.
• Exclusion Criteria:
• • Pelvic inflammatory disease (acute attack);
• • Pregnant or lactating women, women of childbearing age who are unwilling to take effective measures to prevent pregnancy during the trial and within 6 months after the trial;
• • Previously diagnosed with cervical intraepithelial neoplasia, primary/secondary dysmenorrhea, pelvic stasis syndrome and chronic pelvic pain caused by other non-pelvic inflammatory diseases;
• • Complicated with specific vaginitis such as vulvovaginal candidiasis, trichomonas vaginitis, bacterial vaginosis;
• • Gynecological tumors (maximum diameter of uterine fibroids greater than 3cm and submucosal fibroids), endometriosis, adenomyosis, acute cervicitis, tuberculous pelvic inflammatory disease, interstitial cystitis and other diseases related symptoms;
• • Placement of intrauterine device in the past 3 months; absence of uterus and bilateral appendages;
• • Received related treatment or took drugs with similar functions and indications within 14 days before the introduction;
• • Liver function: ALT or AST\>1.5 times the upper limit of normal value；Renal function：Scr\>1.0 times the upper limit of normal value;
• • Serum CA125 and erythrocyte sedimentation \> 1.1 times the upper limit of normal value.
• • Combined with serious cardiovascular, cerebrovascular, hematopoietic system and other serious diseases;
• • Have an allergic history to the experimental drug;
• • Have a long history of alcoholism or drug abuse;
• • Intellectual disabilities or mental disorders;
• • Participated in other clinical trials within the past 3 months;
• • The investigator believes that it is not suitable to participate in this clinical trial.