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Evaluation of the efficacy and safety of Shenpu Pinyan Granules for the treatment of post-sequelae of pelvic inflammatory diseases (damp-heat and blood stasis syndrome) and chronic pelvic pain: A randomized, double-blind, placebo-controlled, dose-finding, multi-center clinical study.

Evaluation of the efficacy and safety of Shenpu Pinyan Granules for the treatment of post-sequelae of pelvic inflammatory diseases (damp-heat and blood stasis syndrome) and chronic pelvic pain: A randomized, double-blind, placebo-controlled, dose-finding, multi-center clinical study.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002229
Enrollment
Unknown
Registered
2025-11-17
Start date
2018-11-18
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-pelvic inflammatory disease sequelae · Chronic pelvic pain

Interventions

Low-dose group:(Shenpu Penyan Granules 1 packet + Shenpu Penyan Granules placebo 2 packets) per dose, orally, 3 times daily.
Mid-dose group:(Shenpu Benyan Granules 2 packets + Shenpu Benyan Granules placebo 1 packet) per dose, orally, 3 times daily.
High-dose group:Shenpu Pienyan Granules, 3 packets per dose, by mouth, 3 times daily.
Placebo group:Shenpu Pianyan Granule Simulant, 3 packets per dose, oral administration, 3 times daily.

Sponsors

The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for post-inflammatory sequelae of pelvic inflammatory disease in Western medicine; 2. Meets the diagnostic criteria for damp-heat and blood stasis syndrome in traditional Chinese medicine; 3. Age between 18 and 50 years, married or unmarried patients with a history of sexual activity; 4. Patients with regular menstrual cycles (menstrual cycle of 21-35 days); 5. 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 (excluding 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 without a uterus or without one or both adnexa; 4. Pregnant women or women planning pregnancy within the next six months, or breastfeeding women; 5. Patients with severe primary diseases such as serious heart, cerebrovascular, liver, kidney, or hematological disorders, diabetes, thyroid diseases, or mental illness; 6. Patients with a history of allergies or hypersensitivity to any components of this medication; 7. Patients who have participated in other clinical studies within the past month or are currently using similar drugs or related treatments, such as antibiotics, which may affect the assessment of drug efficacy; 8. Patients with suspected or confirmed alcohol addiction, drug abuse history, or other conditions that may reduce the likelihood of enrollment or complicate participation, such as frequent changes in work or living environments, which may lead to loss to follow-up; 9. Patients deemed unsuitable for participation in this clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Abdominal/Lumbosacral Pain Visual Analogue Scale( VAS) Score;

Secondary

MeasureTime frame
McCormack Scale Score;Traditional Chinese Medicine syndrome score;Quality of Life SF-36 Brief Health Survey Scoring;

Countries

China

Contacts

Public ContactSong Dianrong

The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

songdr58@126.com13602115295

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026