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
Chronic pelvic pain is the major sequela of pelvic inflammatory disease and it's a common, burdensome, and costly condition that disproportionately affects women. This multicenter, randomized, double-blind, dose-parallel, placebo-controlled phase III clinical trial is designed to evaluate the efficacy and safety of Jincaopian Tablets in the treatment of subjects with chronic pelvic pain after pelvic inflammatory disease. In this trial, 414 subjects were enrolled and randomized to either "Jincaopian Tablets" group, or the "placebo" group in a 2:1 ratio. The treatment period is 12 weeks and the follow-up period is 4 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
414
Jincaopian Tablets 0.2g tid p.o.
Placebo 0.2g tid p.o.
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGPain 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.
Time frame: 12 Weeks
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.
Time frame: 8 Weeks
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.
Time frame: 12 Weeks
The area under the VAS score-time curve
AUC under the curve to evaluating pain levels
Time frame: 12 Weeks
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.
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Time frame: 12 Weeks
General quality of life (Short Form-12) scale
The Short Form-12 is an abbreviated version of the original 36-item QOL questionnaire. It comprises 12 items with a mental component summary (MCS) and a physical component summary (PCS). Possible scores for mental and physical health-related QOL subscales range from 0 to 100 points, and a higher score is interpreted as better QOL.
Time frame: 12 Weeks
Disease efficacy evaluation
Disease efficacy was determined based on the change of the clinical signs and symptoms. Based on the evaluation criteria, the Disease efficacy was recorded as Clinical recovery, significant effect, effectiveness, and ineffectiveness. Clinical recovery: The symptoms and signs disappear, and the integral values of symptoms, signs, and auxiliary examinations decrease by ≥ 95%. Significant effect: The symptoms and signs are significantly reduced, with a reduction of ≥ 70% and\<95% in the score of symptoms, signs, and auxiliary examinations. Effective: Symptoms and signs have been alleviated, with a reduction of ≥ 30% and\<70% in symptom, sign, and auxiliary examination scores. Invalid: No reduction or aggravation of symptoms and signs, with a decrease of\<30% in the score of symptoms, signs, and auxiliary examinations
Time frame: 12 Weeks
Adverse events (AEs)
Incidence of treatment-related AEs
Time frame: 12 Weeks