Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:35 PM
Study NCT ID:
NCT04723069
Status:
COMPLETED
Last Update Posted:
2023-04-04
First Post:
2021-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Fuke Qianjin Capsule in Patients With Pelvic Inflammatory Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000292', 'term': 'Pelvic Inflammatory Disease'}], 'ancestors': [{'id': 'D034161', 'term': 'Pelvic Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}, {'id': 'D008516', 'term': 'Medicine, Chinese Traditional'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D008518', 'term': 'Medicine, East Asian Traditional'}, {'id': 'D008519', 'term': 'Medicine, Traditional'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Participant and investigator both are blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized, double-blind, positive control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-01', 'studyFirstSubmitDate': '2021-01-22', 'studyFirstSubmitQcDate': '2021-01-22', 'lastUpdatePostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Labaratory Examination', 'timeFrame': 'at day 0, 14 and after 28 days of treatment', '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+).'}, {'measure': 'Vital signs examination', 'timeFrame': 'at day 0, 14 and after 28 days of treatment', 'description': 'Blood Pressure Monitoring (Both systolic and diastolic), Body Temperature, Pulse rate, Respiratory Rate'}, {'measure': 'Electrocardiogram', 'timeFrame': 'at day 0, 14 and after 28 days of treatment', 'description': 'ECG evaluation for any abnormality'}], 'primaryOutcomes': [{'measure': 'Improvement in Visual Analog Scale (VAS) for pain assessment', 'timeFrame': 'after 28 days of treatment', '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.'}], 'secondaryOutcomes': [{'measure': 'Assessment of changes in main clinical Symptom', 'timeFrame': 'after 28 days of treatment', '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),'}, {'measure': 'gynaecological B-ultrasound', 'timeFrame': 'after 28 days of treatment', 'description': 'Change in the maximum area of pelvic effusion'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Triditional Chinese Medicine', 'Pelvic Inflammatory Disease (PID)', 'Doxycycline Hyclate', 'Metronidazole'], 'conditions': ['Pelvic Inflammatory Disease']}, 'referencesModule': {'references': [{'pmid': '38584600', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.gov/ct2/show/NCT03251560', 'label': 'The Clinical Effect of Fuke Qianjin Capsule on Chronic Pelvic Pain Caused by Pelvic Inflammation'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Study participants will be randomly assigned to Test or Control group and the following schedule will be followed\n\nTest group: metronidazole tablets + doxycycline hyclate tablets simulant are consecutively taken for 14 days, while Fuke Qianjin capsule is consecutively taken for 28 days.\n\nControl group: metronidazole tablets + doxycycline hyclate tablets, are consecutively taken for 14 days, while Fuke Qianjin capsule simulation is consecutively taken for 28 days.\n\nFuke 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.\n\nScoring pain, symptoms, local signs, routine leucorrhea, cervical secretions, gynaecological B-ultrasound will be examined before the enrollment and after study completion.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Only females with Pelvic inflammatory Disease are Eligible.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients aged 18-55.\n* History of sexual life.\n* Consistent with the diagnosis of pelvic inflammatory disease.\n* VAS score ≥4.\n* Voluntarily participate in the clinical trial and signed the Informed Consent form obtained before any trial-related procedures are performed\n\nExclusion Criteria:\n\n* Patients with severe pelvic inflammatory disease, or patients with dizziness, vomiting, high fever; pelvic abscess; fallopian tube ovarian abscess, etc.\n* Absence of uterus.\n* 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.\n* 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.\n* Patients with neurological and psychiatric disorders and unable or unwilling to cooperate.\n* Allergic (allergic to two or more substances) or allergic to the components of this medicine; Suspected or indeed history of allergy to tetracyclines.\n* Pregnant and breastfeeding women.\n* Treated with similar drugs in the past 2 weeks.\n* Those who are participating in or have participated in other clinical trials in the past 3 months.\n* 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.'}, 'identificationModule': {'nctId': 'NCT04723069', 'briefTitle': 'Efficacy and Safety of Fuke Qianjin Capsule in Patients With Pelvic Inflammatory Diseases', 'organization': {'class': 'OTHER', 'fullName': 'University of Karachi'}, 'officialTitle': 'A Randomized, Double-blind, Positive-Controlled Study to Evaluate the Efficacy and Safety of Fuke Qianjin Capsule in Patients With Pelvic Inflammatory Diseases', 'orgStudyIdInfo': {'id': 'CRO-007-TCM-FKQJ -2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fuke Qianjin capsule', 'description': 'Metronidazole tablets + Doxycycline Hyclate tablets simulant are consecutively taken for 14 days, while the Fuke Qianjin capsule is consecutively taken for 28 days.\n\nFuke 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.', 'interventionNames': ['Drug: Control Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metronidazole tablets + Doxycycline hyclate tablets', 'description': 'Metronidazole tablets + Doxycycline hyclate tablets are consecutively taken for 14 days, while Fuke Qianjin capsule simulation is consecutively taken for 28 days.\n\nFuke 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.', 'interventionNames': ['Drug: Test Group']}], 'interventions': [{'name': 'Control Group', 'type': 'DRUG', 'otherNames': ['Traditional Chinese Medicine (TCM)'], 'description': 'metronidazole tablets + doxycycline hyclate tablets, are consecutively taken for 14 days, while Fuke Qianjin capsule simulation is consecutively taken for 28 days.', 'armGroupLabels': ['Fuke Qianjin capsule']}, {'name': 'Test Group', 'type': 'DRUG', 'description': 'metronidazole tablets + doxycycline hyclate tablets simulant are consecutively taken for 14 days, while Fuke Qianjin capsule is consecutively taken for 28 days.', 'armGroupLabels': ['Metronidazole tablets + Doxycycline hyclate tablets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75270', 'city': 'Karachi', 'country': 'Pakistan', 'facility': 'Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Professor Dr. Muhammad Raza Shah', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for bioequivalence studies and Clinical Research (CBSCR), ICCBS, University of Karachi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Karachi', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zhuzhou Qianjin Pharmaceutical Co., Ltd., 801, Zhuzhou, China', 'class': 'UNKNOWN'}, {'name': 'Center for bioequivalence studies and Clinical Research (CBSCR), ICCBS, University of Karachi', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr. Muhammad Raza Shah', 'investigatorAffiliation': 'University of Karachi'}}}}