Post-pelvic inflammatory disease sequelae · Chronic pelvic pain
Conditions
Interventions
Experimental drug group:Shenpu Pienyan Granules, 2 packets per dose, dissolved in 150-200ml of warm water, 3 times daily.
Placebo group:Shenpu Pianyan Granule Simulator, 150-200ml warm water, dissolve and take, 2 packets per dose, 3 times daily.
Sponsors
Medical Ethics Committee of the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for post-inflammatory pelvic disease with chronic pelvic pain in Western medicine; 2. Meets the diagnostic criteria for damp-heat and blood stasis syndrome in Traditional Chinese Medicine; 3. The maximum VAS score for abdominal or lumbosacral pain during the screening/induction period is =40; 4. Patients aged between 18-50 years, married or unmarried, with a history of sexual activity; 5. Patients with regular menstrual cycles (menstrual cycle duration of 21-35 days); 6. Voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with acute pelvic inflammatory diseases; 2. Patients confirmed by examination to have symptoms caused by gynecological tumors (except for uterine fibroids smaller than 3 cm), specific vaginitis (e.g., vulvovaginal candidiasis, trichomoniasis, bacterial vaginosis), endometriosis, adenomyosis, tuberculous pelvic inflammation, pelvic abscess, pelvic mass, cervical lesions, or other conditions; 3. Patients with a confirmed history of cervical intraepithelial neoplasia, primary/secondary dysmenorrhea, pelvic congestion syndrome, or chronic pelvic pain caused by non-pelvic inflammatory diseases; 4. Patients with serum creatinine exceeding the upper limit of normal or ALT or AST more than 1.5 times the upper limit of normal; 5. Patients with absence of the uterus and/or adnexa; 6. Pregnant women, women planning pregnancy within six months, or breastfeeding women; 7. Patients with severe primary diseases such as cardiovascular, cerebrovascular, hepatic, renal, hematological disorders, diabetes, thyroid diseases, or mental illness; 8. Patients with an allergic constitution or allergy to any component of this medication; 9. Participants who have been involved in other clinical studies within the past month or have been using similar drugs or related treatments within the month prior to randomization, making it difficult to assess drug efficacy; 10. Participants with suspected or confirmed alcohol addiction, drug abuse history, or other conditions deemed by the investigator to reduce the likelihood of enrollment or complicate participation, such as frequent changes in work or living environments leading to potential loss to follow-up; 11. Participants deemed unsuitable for this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the maximum Visual Analogue Scale( VAS) score for abdominal/lumbosacral pain compared to baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the maximum Visual Analogue Scale( VAS) score for abdominal/lumbosacral pain compared to baseline.;The change in the total score of the McCormack Scale compared to baseline.;Traditional Chinese Medicine (TCM) Syndrome Efficacy;Quality of Life SF-12 Health Survey Scoring; | — |
Countries
China
Contacts
Public ContactSong Dianrong
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed