A Phase 2 interventional study of Control Group and Test Group in Pelvic Inflammatory Disease, sponsored by University of Karachi. Completed at 1 site in Pakistan. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-04-04.
Sponsored by University of Karachi · Phase 2, Interventional, and Treatment
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 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.
37 studies on the registry are indexed under Pelvic Inflammatory Disease; 5 are open to participants now.
This study's enrollment of 198 is above the median of 163 across 30 interventional studies indexed under Pelvic Inflammatory Disease.
Browse Pelvic Inflammatory Disease studies →University of Karachi is the lead sponsor of 36 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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. 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, are consecutively taken for 14 days, while Fuke Qianjin capsule simulation is consecutively taken for 28 days.
Also known as: Traditional Chinese Medicine (TCM)
metronidazole tablets + doxycycline hyclate tablets simulant are consecutively taken for 14 days, while Fuke Qianjin capsule is consecutively taken for 28 days.
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.
Time frame: after 28 days of treatment
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),
Time frame: after 28 days of treatment
gynaecological B-ultrasound
Change in the maximum area of pelvic effusion
Time frame: after 28 days of treatment
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+).
Time frame: 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
Time frame: at day 0, 14 and after 28 days of treatment
Electrocardiogram
ECG evaluation for any abnormality
Time frame: at day 0, 14 and after 28 days of treatment
Plan to share: No
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University of Karachi