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Golden grass piece of treatment of pelvic inflammatory disease sequelae of chronic pelvic pain efficacy and safety of multicenter, randomized, double-blind, parallel-group dose, placebo-controlled phase II trial

Golden grass piece of treatment of pelvic inflammatory disease sequelae of chronic pelvic pain efficacy and safety of multicenter, randomized, double-blind, parallel-group dose, placebo-controlled phase II trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005002
Enrollment
Unknown
Registered
2021-06-29
Start date
2021-01-01
Completion date
Unknown
Last updated
2023-02-20

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 Chronic pelvic pain

Interventions

Sponsors

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: (1) It meets the diagnostic criteria of chronic pelvic pain in the sequelae of pelvic inflammatory diseases; (2) The average score of pain VAS in the week before inclusion >=4; (3) At the time of enrollment, the MC Cormack Scale scored 4-12 points (including 4 points and 12 points); (4) Female aged 18 to 55 years (including 18 and 55 years), who have a sexual life history; (5) Volunteered to participate in this clinical trial, informed consent and signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Pelvic inflammatory disease (acute attack); (2) pregnant and lactating women who are unwilling to take effective measures to prevent pregnancy during the trial and within 3 months after the end of the trial; (3) Critical condition or indications of operation, such as complicated with diffuse peritonitis and sepsis; (4) Chronic pelvic pain caused by cervical intraepithelial neoplasia, primary/secondary dysmenorrhea, pelvic stasis syndrome and other non-pelvic inflammatory diseases have been clearly diagnosed in the past; (5) Specific vaginitis, such as vulvovaginal candidiasis, trichomoniasis vaginitis and bacterial vaginosis, were complicated at the time of enrollment; (6) Gynecological tumors (uterine fibroids with maximum diameter greater than 3cm and submucosal fibroids), endometriosis, myoadenosis, acute cervicitis, tuberculous pelvic inflammatory disease, interstitial cystitis and other diseases caused by related symptoms; (7) IUD was placed in the last 3 months; Absence of uterus and bilateral appendages; (8) Have received relevant treatment or taken drugs with similar functions within 14 days before introduction; (9) Liver function index (ALT, AST) >=1.5 ULN, and renal function index SCR >=1 ULN; (10) Serum CA125 and erythrocyte sedimentation rate >=1.5 ULN; (11) Routine blood indicators (RBC, WBC, HB, PLT) >=1.5 ULN; Fasting blood glucose exceeded the upper limit of the normal reference value; Twelve lead electrocardiogram showed abnormal QT interval (12) Complicated with serious cardiovascular, cerebrovascular, hematopoietic system and other serious diseases; (13) Have a history of allergy to test drug ingredients; (14) A history of long-term alcohol and drug abuse; (15) having intellectual or mental retardation; (16) Participated in other clinical trials within the last 3 months; (17)The investigator did not consider it appropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Pregnancy test;liver function;Routine blood test;12-lead electrocardiogram;renal function;Urinary routine;

Countries

China

Contacts

Public ContactTeng Xiuxiang

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

tengxx@126.com+86 010-87906734

Outcome results

None listed

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