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

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Karachi
• Collaborators: The Jinnah Postgraduate Medical Centre, Karachi, Sindh 75510, Pakistan; The Jinnah Postgraduate Medical Centre, Rafiqui، Sarwar Shaheed Rd, Karachi Cantonment, Karachi, Karachi City, Sindh 75510; Zhuzhou Qianjin Pharmaceutical Co., Ltd., 801, Zhuzhou, China
• Treatments: Doxycycline; Metronidazole

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; or patients with axillary temperature exceeding 38.5 ° C.

• Absence of uterus.

• Patients with gynaecological tumors (uterine fibroids > 3 cm in diameter, submucosal fibroids), specific vaginitis (trichomonal vaginitis, mycotic vaginitis, bacterial vaginosis), adenomyosis, endometriosis, pelvic venous stasis, tuberculous pelvic inflammatory disease, abnormal uterine bleeding, etc. confirmed by examination, and related symptoms caused by other diseases.

• Complicated with severe primary diseases of heart, liver, kidney, hematopoietic system and other vital organs and systems, which are judged by the investigator to have an impact on clinical trials. Liver function ALT or AST greater than the upper limit of normal 50%, renal function BUN or Cr greater than the upper limit of normal 20%.

• Combined with neurological and psychiatric disorders and unable or unwilling to cooperate.

• Allergic constitution (allergic to more than two substances) or allergic to the components of this drug; suspected or definite history of allergy to tetracyclines.

• Pregnant, breastfeeding, preparing for pregnant (within 6 months).

• 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.