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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04723069
Other study ID # CRO-007-TCM-FKQJ -2020
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 21, 2021
Est. completion date March 11, 2022

Study information

Verified date April 2023
Source University of Karachi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 198
Est. completion date March 11, 2022
Est. primary completion date March 11, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
Test Group
metronidazole tablets + doxycycline hyclate tablets simulant are consecutively taken for 14 days, while Fuke Qianjin capsule is consecutively taken for 28 days.

Locations

Country Name City State
Pakistan Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi Karachi

Sponsors (3)

Lead Sponsor Collaborator
University of Karachi Center for bioequivalence studies and Clinical Research (CBSCR), ICCBS, University of Karachi, Zhuzhou Qianjin Pharmaceutical Co., Ltd., 801, Zhuzhou, China

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Other Labaratory Examination Routine blood tests for liver function (alanine aminotransferase ALT, aspartate aminotransferase AST, ?-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
Other 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
Other Electrocardiogram ECG evaluation for any abnormality at day 0, 14 and after 28 days of treatment
Primary 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 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
Secondary gynaecological B-ultrasound Change in the maximum area of pelvic effusion after 28 days of treatment
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