A Randomized, Double-blind, Positive-Controlled Study to Evaluate the Efficacy and Safety of Fuke Qianjin Capsule in Patients With Pelvic Inflammatory Diseases

CRO-007-TCM-FKQJ -2020

Randomized, double blind and positive-controlled clinical trial to assess the efficacy and safety of Fuke Qianjin Capsule compared to Doxycycline Hyclate Tablet in patients with mild to medium PID and its sequalae.

2021-09-21

2022-03-11

2022-03-11

Completed

Early phase I

198

Inclusion Criteria: * Female patients aged 18-55. * History of sexual life. * Consistent with the diagnosis of pelvic inflammatory disease. * VAS score ≥4. * Voluntarily participate in the clinical trial and signed the Informed Consent form obtained before any trial-related procedures are performed Exclusion Criteria: * Patients with severe pelvic inflammatory disease, or patients with dizziness, vomiting, high fever; pelvic abscess; fallopian tube ovarian abscess, etc. * Absence of uterus. * Patients with gynaecological tumors (uterine fibroids \> 5 cm in diameter, submucosal fibroids), specific vaginitis, adenomyosis, endometriosis, pelvic venous stasis, tuberculous pelvic inflammatory disease, abnormal uterine bleeding, etc. confirmed by examination, and related symptoms caused by other diseases. * Patients with serious primary diseases of the heart, liver, kidney, hematopoietic system and those who have an impact on clinical trial as judged by the investigator. * Patients with neurological and psychiatric disorders and unable or unwilling to cooperate. * Allergic (allergic to two or more substances) or allergic to the components of this medicine; Suspected or indeed history of allergy to tetracyclines. * Pregnant and breastfeeding women. * Treated with similar drugs in the past 2 weeks. * Those who are participating in or have participated in other clinical trials in the past 3 months. * Suspected or confirmed history of alcohol or drug abuse, or other lesions or conditions that may reduce the possibility or complicate enrolment according to the judgment of the investigator, such as frequent changes in work environment and unstable living environment, which may easily lead to loss of follow-up.

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2023-04-04