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

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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Inflammatory Disease
• Intervention / Treatment: Drug: Control Group; Drug: Test Group

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.

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Phase 2

Contacts and Locations

Study Locations

• Pakistan
  • Karachi, Pakistan, 75270
    • Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fuke Qianjin capsule; Metronidazole tablets + Doxycycline Hyclate tablets simulant are consecutively taken for 14 days, while the Fuke Qianjin capsule is consecutively taken for 28 days. Fuke Qianjin Capsules 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 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.	Drug: Control Group; metronidazole tablets + doxycycline hyclate tablets, are consecutively taken for 14 days, while Fuke Qianjin capsule simulation is consecutively taken for 28 days.; Other Names: Traditional Chinese Medicine (TCM)
Active Comparator: Metronidazole tablets + Doxycycline hyclate tablets; 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 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 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.	Drug: Test Group; metronidazole tablets + doxycycline hyclate tablets simulant are consecutively taken for 14 days, while Fuke Qianjin capsule is consecutively taken for 28 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Visual Analog Scale (VAS) for pain assessment	Applying the Visual Analogue Scale (VAS) i.e. 0-10 Numeric Pain Intensity Scale on a 10 cm line segment the pain will be assessed as 0 is painless, 10 is extremely painful. Patients will mark in the corresponding position according to the degree of pain, and the researcher will give a specific score. The grading criteria of Pelvic pain with VAS score will be, normal: 0 cm; mild: 1-3 cm; moderate: 4-6 cm; severe: 7-10 cm.	after 28 days of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of changes in main clinical Symptom	Main Clinical symptoms including Lower abdominal pain (Score 0 points: No Pain, 2 points: Mild, 4 points: Moderate and 6 points: Severe ), Lumbosacral pain (Score 0 points: No Pain, 2 points: Mild, 4 points: Moderate and 6 points: Severe ) and Yellow leucorrhea (Score 0 points: Normal, 2 points: light yellow, 4 points: yellow discharge and 6 points: Yellowish green as pus),	after 28 days of treatment
gynaecological B-ultrasound	Change in the maximum area of pelvic effusion	after 28 days of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Labaratory Examination	Routine blood tests for liver function (alanine aminotransferase ALT, aspartate aminotransferase AST, γ-glutamyltransferase GGT, alkaline phosphatase ALP, total bilirubin T.BIL); Blood routine (WBC, RBC, HB, PLT, NEU%, LYM%, MONO%, EOS%); Urine routine (LEU, ERY, PRO, GLU, pH, KET); Liver function (AST, ALT, TBiL, ALP, GMT, LDH, AMS); Renal function (BUN, Cr, UA); Electrolytes(Na+, K+, Cl-, Ca+).	at day 0, 14 and after 28 days of treatment
Vital signs examination	Blood Pressure Monitoring (Both systolic and diastolic), Body Temperature, Pulse rate, Respiratory Rate	at day 0, 14 and after 28 days of treatment
Electrocardiogram	ECG evaluation for any abnormality	at day 0, 14 and after 28 days of treatment

Collaborators and Investigators

• Sponsor: University of Karachi
• Collaborators: Zhuzhou Qianjin Pharmaceutical Co., Ltd., 801, Zhuzhou, China; Center for bioequivalence studies and Clinical Research (CBSCR), ICCBS, University of Karachi
• Investigators: Principal Investigator: Professor Dr. Muhammad Raza Shah, Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi

Publications and helpful links

Helpful Links

• Fuke Qianjin Combined with Antibiotic Therapy for Pelvic Inflammatory Disease: A Systematic Review and Meta-Analysis
• The Clinical Effect of Fuke Qianjin Capsule on Chronic Pelvic Pain Caused by Pelvic Inflammation

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2021
• Primary Completion (Actual): March 11, 2022
• Study Completion (Actual): March 11, 2022

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 1, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Metronidazole; Pelvic Inflammatory Disease (PID); Doxycycline Hyclate; Triditional Chinese Medicine
• Additional Relevant MeSH Terms: Infections; Adnexal Diseases; Pelvic Inflammatory Disease; Pelvic Infection; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Metronidazole; Doxycycline
• Other Study ID Numbers: CRO-007-TCM-FKQJ -2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No