The objective of this phase III trial to evaluate the efficacy and safety of Jincaopian Tablets in the treatment of subjects with chronic pelvic pain after pelvic inflammatory disease
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;
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;
Parallel
Jincaopian Tablets
DrugJincaopian Tablets 0.2g tid p.o.
Placebo
Other interventionPlacebo 0.2g tid p.o.
Pain disappearance rate after 12 weeks of treatment
The pain disappearance referred to the Visual Analogue Scale (VAS) score becoming 0-1 points, and was no longer greater than or equal to 2 points at any subsequent evaluation. The pain disappearance rate was defined as the proportion of patients who achieved a pain disappearance after treatment.
Pain disappearance rate after 4 and 8 weeks of treatment
The pain disappearance referred to the Visual Analogue Scale (VAS) score becoming 0-1 points, and was no longer greater than or equal to 2 points at any subsequent evaluation. The pain disappearance rate was defined as the proportion of patients who achieved a pain disappearance after treatment.
Change of weekly average Visual Analogue Scale (VAS) score from baseline after 12 weeks of treatment
Visual Analogue Scale (VAS) was used to evaluate pelvic pain degree. The VAS score ranged from 0 to 10, and a higher score represented greater pain intensity. The average VAS value for a week was calculated by dividing the sum of the scores for each day of the week by the number of days the score was recorded.
The area under the VAS score-time curve
AUC under the curve to evaluating pain levels
McCormick Scale
The McCormack scale was used to score the patient's physical signs. The total score is 36 points, rated from twelve aspects including uterine tenderness (divided into four quadrants), abdominal tenderness or rebound pain (divided into four quadrants), left or right adnexal tenderness, uterine tenderness, and cervical lifting and swinging pain. The scoring criteria was as following: no pain is 0 points; Mild pain without facial expression changes and muscle tension is 1 point; Pain accompanied by facial expressions and muscle tension is 2 points; Pain drama is 3 points.
Click on the lead sponsor to view all of their trials.
