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Efficacy and safety of Kang-Fu-Yan capsules for relieving sequelae of pelvic inflammatory disease-chronic pelvic pain: a multicenter, randomized, controlled, double-blind, parallel-group, clinical trial

Efficacy and safety of Kang-Fu-Yan capsules for relieving sequelae of pelvic inflammatory disease-chronic pelvic pain: a multicenter, randomized, controlled, double-blind, parallel-group, clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022732
Enrollment
Unknown
Registered
2019-04-24
Start date
2014-09-30
Completion date
Unknown
Last updated
2019-04-30

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

Conditions

Pelvic inflammatory disease sequelae caused by chronic pelvic pain

Interventions

Experimental group:Kang-Fu-Yan capsule
control group:Gong-Yan-Ping capsule

Sponsors

Dongfang Hospital Affiliated to Beijing University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Accord with Sequelae of pelvic inflammatory disease diagnostic criteria, Chronic pelvic pain lasts for more than six months; 2. Conform to the TCM Syndrome Differentiation of hot and humid betting And Blood stasis of collaterals; 3. Female aged between 20 to 50 years, married or with sexual life history person; 4. The menstrual cycle was 28 to 35 days; 5. The degree of chronic pelvic pain (VAS) score =4; 6. The Subjects informed consent, voluntary acceptance test, procedure to obtain informed consent in accordance with the provisions of GCP.

Exclusion criteria

Exclusion criteria: 1. Pregnancy, or Planned pregnancy within half a year, or Lactation; 2. The examination was confirmed by gynecological tumor (The maximum diameter of uterine fibroids is more than 3cm), trichomonas vaginitis, vulvovaginal candidiasis, acute cervicitis, pelvic inflammatory disease, endometriosis, adenomyosis, pelvic venous stasis syndrome, interstitial cystitis (IC) and related symptoms caused by other diseases; 3. Serum CA-125>=35U/ml or ESR> 25mm/h (Westergren method); 4. Combined with severe primary diseases such as cardiovascular, liver, kidney and blood system or psychopaths, blood ALT, AST > normal upper limit, blood creatinine (Cr) > normal upper limit; 5. Received similar treatments and similar function drugs within two weeks; 6. Patients are participating in other clinical trials or using antibiotics for treatment within 1 months; 7. Allergic constitution or allergic to the trial drug or allergic to the ingredients; 8. The disabled patients (blind, deaf, mute, amentia, mental disorder, physical disability) prescribed by law; 9. Subjects were suspected or confirmed to a history of alcohol or drug abuse.

Design outcomes

Primary

MeasureTime frame
The degree of improvement in the main symptoms (distension or tingling of the lower abdomen);Curative effect of the disease;

Secondary

MeasureTime frame
The efficacy of TCM Syndrome;Change of the score of each individual symptoms and local signs;Change of the dimensions of EQ-5D;The recurrence of abdominal pain (the next menstrual cycle);Change of the pelvic mass and effusion after the treatment;

Countries

China

Contacts

Public ContactJin Zhe

Dongfang Hospital, Beijing University of Chinese Medicine

Jzhe0105@126.com+86 010-6766 4723

Outcome results

None listed

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