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| Name | Class |
|---|---|
| Zhuzhou Qianjin Pharmaceutical Co., Ltd., 801, Zhuzhou, China | UNKNOWN |
| Center for Bioequivalence Studies and Clinical Research | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fuke Qianjin capsule | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Group | Drug | metronidazole tablets + doxycycline hyclate tablets, are consecutively taken for 14 days, while Fuke Qianjin capsule simulation is consecutively taken for 28 days. |
| 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 |
| 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), |
| 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+). |
Inclusion Criteria:
Exclusion Criteria:
Only females with Pelvic inflammatory Disease are Eligible.
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| Name | Affiliation | Role |
|---|---|---|
| Professor Dr. Muhammad Raza Shah | Center for Bioequivalence Studies and Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi | Karachi | 75270 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38584600 | Derived | Shah MR, Khan SN, Fatima S, Yao L, Yuan H, Ullah S, Ainuddin J, Zeng C, Zheng Y, Sahar N, Anwar S, Zhu M, Ma C, Kumari K, Wang W, Liu R. A randomized, double-blind, positive-controlled, Phase-II clinical trial to evaluate efficacy and safety of Fuke Qianjin capsule in Pakistani patients with pelvic inflammatory disease. Front Pharmacol. 2024 Mar 22;15:1287321. doi: 10.3389/fphar.2024.1287321. eCollection 2024. |
| Label | URL |
|---|---|
| The Clinical Effect of Fuke Qianjin Capsule on Chronic Pelvic Pain Caused by Pelvic Inflammation | View source |
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| ID | Term |
|---|---|
| D000292 | Pelvic Inflammatory Disease |
| ID | Term |
|---|---|
| D034161 | Pelvic Infection |
| D007239 | Infections |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| D008516 | Medicine, Chinese Traditional |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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randomized, double-blind, positive control
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Participant and investigator both are blind
|
| Test Group | Drug | metronidazole tablets + doxycycline hyclate tablets simulant are consecutively taken for 14 days, while Fuke Qianjin capsule is consecutively taken for 28 days. |
|
| after 28 days of treatment |
| gynaecological B-ultrasound | Change in the maximum area of pelvic effusion | after 28 days of treatment |
| 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 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D008722 | Methods |
| D008518 | Medicine, East Asian Traditional |
| D008519 | Medicine, Traditional |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |