Status:
COMPLETED
Efficacy and Safety of Fuke Qianjin Capsule in Patients With Pelvic Inflammatory Diseases
Lead Sponsor:
University of Karachi
Collaborating Sponsors:
Zhuzhou Qianjin Pharmaceutical Co., Ltd., 801, Zhuzhou, China
Center for bioequivalence studies and Clinical Research (CBSCR), ICCBS, University of Karachi
Conditions:
Pelvic Inflammatory Disease
Eligibility:
FEMALE
18-55 years
Phase:
PHASE2
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...
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 consecut...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2022
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT04723069
Start Date
September 21 2021
End Date
March 11 2022
Last Update
April 4 2023
Active Locations (1)
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1
Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi
Karachi, Pakistan, 75270