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

Pelvic Inflammatory Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

Study participants will be randomly assigned to Test or Control group and the following schedule will be followed Test group: metronidazole tablets + doxycycline hyclate tablets simulant are consecutively taken for 14 days, while Fuke Qianjin capsule is consecutively taken for 28 days. Control group: metronidazole tablets + doxycycline hyclate tablets, are consecutively taken for 14 days, while Fuke Qianjin capsule simulation is consecutively taken for 28 days. Fuke Qianjin Capsules and their simulants are taken as 2 capsules at a time, 3 times a day, orally after breakfast, lunch and dinner, respectively; Metronidazole Tablets are taken as 2 tablets (0.2 g/tablet) at a time, twice a day, at the same time as breakfast and dinner, respectively; Doxycycline Hyclate Tablet and their simulants are taken as 1 tablet (0.1 g/tablet, Doxycycline Hyclate Tablet calculated as C22H24N2O8) at a time, twice a day, at the same time as breakfast and dinner, respectively. Scoring pain, symptoms, local signs, routine leucorrhea, cervical secretions, gynaecological B-ultrasound will be examined before the enrollment and after study completion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04723069
Study type Interventional
Source University of Karachi
Contact
Status Completed
Phase Phase 2
Start date September 21, 2021
Completion date March 11, 2022
View Details
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