Clinical trial NCT04723069: Efficacy and Safety of Fuke Qianjin Capsule in Patients With Pelvic Inflammatory Diseases
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pelvic Inflammatory Disease
Keywords: Triditional Chinese Medicine
Pelvic Inflammatory Disease (PID)
Doxycycline Hyclate
Metronidazole
Lead sponsor: University of Karachi
Sponsor class: OTHER
Collaborators: name: Zhuzhou Qianjin Pharmaceutical Co., Ltd., 801, Zhuzhou, China
name: Center for bioequivalence studies and Clinical Research (CBSCR), ICCBS, University of Karachi
First posted: 2021-01-25
Enrollment: 198
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double-blind, positive control
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in Visual Analog Scale (VAS) for pain assessment
timeFrame: after 28 days of treatment
Secondary outcomes:
measure: Assessment of changes in main clinical Symptom
timeFrame: after 28 days of treatment
measure: gynaecological B-ultrasound
timeFrame: after 28 days of treatment
Other outcomes:
measure: Labaratory Examination
timeFrame: at day 0, 14 and after 28 days of treatment
measure: Vital signs examination
timeFrame: at day 0, 14 and after 28 days of treatment
measure: Electrocardiogram
timeFrame: at day 0, 14 and after 28 days of treatment
Locations:
city: Karachi
country: Pakistan
facility: Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi
Study officials:
affiliation: Center for bioequivalence studies and Clinical Research (CBSCR), ICCBS, University of Karachi
name: Professor Dr. Muhammad Raza Shah
role: PRINCIPAL_INVESTIGATOR
References: