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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
198
metronidazole tablets + doxycycline hyclate tablets, are consecutively taken for 14 days, while Fuke Qianjin capsule simulation is consecutively taken for 28 days.
metronidazole tablets + doxycycline hyclate tablets simulant are consecutively taken for 14 days, while Fuke Qianjin capsule is consecutively taken for 28 days.
Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi
Karachi, Pakistan
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
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