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

Primary Purpose

Pelvic Inflammatory Disease

Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
Control Group
Test Group
Sponsored by
University of Karachi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Inflammatory Disease focused on measuring Triditional Chinese Medicine, Pelvic Inflammatory Disease (PID), Doxycycline Hyclate, Metronidazole

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fuke Qianjin capsule

Metronidazole tablets + Doxycycline hyclate tablets

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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),
gynaecological B-ultrasound
Change in the maximum area of pelvic effusion

Full Information

First Posted
January 22, 2021
Last Updated
April 1, 2023
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
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1. Study Identification

Unique Protocol Identification Number
NCT04723069
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 21, 2021 (Actual)
Primary Completion Date
March 11, 2022 (Actual)
Study Completion Date
March 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Inflammatory Disease
Keywords
Triditional Chinese Medicine, Pelvic Inflammatory Disease (PID), Doxycycline Hyclate, Metronidazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
randomized, double-blind, positive control
Masking
ParticipantInvestigator
Masking Description
Participant and investigator both are blind
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fuke Qianjin capsule
Arm Type
Experimental
Arm Description
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.
Arm Title
Metronidazole tablets + Doxycycline hyclate tablets
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Control Group
Other Intervention Name(s)
Traditional Chinese Medicine (TCM)
Intervention Description
metronidazole tablets + doxycycline hyclate tablets, are consecutively taken for 14 days, while Fuke Qianjin capsule simulation is consecutively taken for 28 days.
Intervention Type
Drug
Intervention Name(s)
Test Group
Intervention Description
metronidazole tablets + doxycycline hyclate tablets simulant are consecutively taken for 14 days, while Fuke Qianjin capsule is consecutively taken for 28 days.
Primary Outcome Measure Information:
Title
Improvement in Visual Analog Scale (VAS) for pain assessment
Description
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.
Time Frame
after 28 days of treatment
Secondary Outcome Measure Information:
Title
Assessment of changes in main clinical Symptom
Description
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),
Time Frame
after 28 days of treatment
Title
gynaecological B-ultrasound
Description
Change in the maximum area of pelvic effusion
Time Frame
after 28 days of treatment
Other Pre-specified Outcome Measures:
Title
Labaratory Examination
Description
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+).
Time Frame
at day 0, 14 and after 28 days of treatment
Title
Vital signs examination
Description
Blood Pressure Monitoring (Both systolic and diastolic), Body Temperature, Pulse rate, Respiratory Rate
Time Frame
at day 0, 14 and after 28 days of treatment
Title
Electrocardiogram
Description
ECG evaluation for any abnormality
Time Frame
at day 0, 14 and after 28 days of treatment

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only females with Pelvic inflammatory Disease are Eligible.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor Dr. Muhammad Raza Shah
Organizational Affiliation
Center for bioequivalence studies and Clinical Research (CBSCR), ICCBS, University of Karachi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi
City
Karachi
ZIP/Postal Code
75270
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://clinicaltrials.gov/ct2/show/NCT03251560
Description
The Clinical Effect of Fuke Qianjin Capsule on Chronic Pelvic Pain Caused by Pelvic Inflammation
URL
https://www.hindawi.com/journals/ecam/2020/5372839/
Description
Fuke Qianjin Combined with Antibiotic Therapy for Pelvic Inflammatory Disease: A Systematic Review and Meta-Analysis

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

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