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A placebo-controlled, block-randomized, double-blind, multi-center clinical study to evaluate the efficacy of Fuyan San (a traditional Chinese medicine) in the treatment of post-pelvic inflammatory disease sequelae.

A placebo-controlled, block-randomized, double-blind, multi-center clinical study to evaluate the efficacy of Fuyan San (a traditional Chinese medicine) in the treatment of post-pelvic inflammatory disease sequelae.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000261
Enrollment
Unknown
Registered
2026-02-03
Start date
2026-02-10
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Sequelae of Pelvic Inflammatory Disease

Interventions

Experimental Group:Fuyan San Chinese Herbal Pack (Standard Dosage)
Control Group:Fuyan San Chinese herbal medicine package (low dose/placebo)

Sponsors

Guizhou University of Traditional Chinese Medicine First Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria (1) Patients who meet the diagnostic criteria for SPID in Western medicine. (2) Patients who meet the diagnostic criteria for the damp-heat and blood stasis pattern. (3) Patients with a pain score NRS =4. (4) Patients aged 20-45 years with a history of sexual activity. (5) Patients with regular menstrual cycles of 28-35 days, and each menstrual period lasting 3-7 days. (6) Patients who voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion Criteria (1) Participants who do not meet the SPID diagnostic criteria; (2) Women in pregnancy, lactation, with fertility intentions, or with menstrual cycle disorders; (3) Patients with severe cardiovascular, hepatic, renal, or hematological diseases; (4) Patients with confirmed gynecological tumors (including uterine fibroids with a single maximum diameter >3cm), acute cervicitis, adenomyosis, endometriosis, pelvic congestion syndrome, or tuberculous pelvic inflammation; (5) Patients with pelvic masses >6cm; (6) Patients with concurrent vulvovaginal candidiasis, bacterial vaginosis, or trichomoniasis; (7) Patients with acute pelvic inflammatory disease; (8) Patients with a history of allergy or hypersensitivity to the drugs used in this trial; (9) Patients with local skin erythema, infection, ulceration, or contagious dermatoses; (10) Patients with mental or cognitive disorders, or intellectual disabilities that prevent cooperation; (11) Patients who have received similar drug therapy in the past 2 months, which may affect the interpretation of trial results.

Design outcomes

Primary

MeasureTime frame
Chronic pelvic pain disappearance rate;

Secondary

MeasureTime frame
Chronic pelvic pain disappearance rate;Local Sign Scoring;TCM syndrome score;B-mode ultrasound;

Countries

China

Contacts

Public ContactZhai Tingting

Guizhou University of Traditional Chinese Medicine First Affiliated Hospital

1909512761@qq.com15286069988

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026