Efficacy and Safety of Fuke Qianjin Capsule in Patients With Pelvic Inflammatory Diseases

Phase 2 Completed 198 enrolled University of Karachi Center for Bioequivalence Studies and Clinical Research · collab Zhuzhou Qianjin Pharmaceutical Co., Ltd., 801, Zhuzhou, China · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start: 2021-09-21
Primary completion: 2022-03-11
Completion: 2022-03-11

Outcome

Met primary endpoint

paper the primary efficacy was 84.9% for the test group and 71.6% for the control group, with a statistically significant difference (p = 0.0370; PMID 38584600 ↗

Publications

Shah MR, Khan SN, Fatima S, Yao L, Yuan H, Ullah S, Ainuddin J, Zeng C, Zheng Y, Sahar N, Anwar S, Zhu M, Ma C, Kumari K, Wang W, Liu R. A randomized, double-blind, positive-controlled, Phase-II clinical trial to evaluate efficacy and safety of Fuke Qianjin capsule in Pakistani patients with pelvic inflammatory disease. Front Pharmacol. 2024 Mar 22;15:1287321. doi: 10.3389/fphar.2024.1287321. eCollection 2024.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Doxycycline hyclate	Small molecule	0.1 g	Oral
Subject	Fuke Qianjin capsule	Unknown	—	Oral
Subject	Metronidazole	Small molecule	0.4 g	Oral