Nctid:
NCT06234514
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000004487", "term"=>"Edema"}], "browseLeaves"=>[{"id"=>"M7657", "name"=>"Edema", "asFound"=>"Edema", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000069579", "term"=>"Ranibizumab"}], "ancestors"=>[{"id"=>"D000020533", "term"=>"Angiogenesis Inhibitors"}, {"id"=>"D000043924", "term"=>"Angiogenesis Modulating Agents"}, {"id"=>"D000006133", "term"=>"Growth Substances"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000006131", "term"=>"Growth Inhibitors"}, {"id"=>"D000000970", "term"=>"Antineoplastic Agents"}], "browseLeaves"=>[{"id"=>"M472", "name"=>"Ranibizumab", "asFound"=>"Had", "relevance"=>"HIGH"}, {"id"=>"M11110", "name"=>"Liver Extracts", "relevance"=>"LOW"}, {"id"=>"M22318", "name"=>"Angiogenesis Inhibitors", "relevance"=>"LOW"}, {"id"=>"M9231", "name"=>"Growth Inhibitors", "relevance"=>"LOW"}, {"id"=>"T208", "name"=>"Licorice", "relevance"=>"LOW"}, {"id"=>"T108", "name"=>"Chinese Salvia", "relevance"=>"LOW"}, {"id"=>"T255", "name"=>"Plantain", "relevance"=>"LOW"}, {"id"=>"T114", "name"=>"Chrysanthemum", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"Herbal and Botanical", "abbrev"=>"HB"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>100}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-30", "studyFirstSubmitDate"=>"2024-01-21", "studyFirstSubmitQcDate"=>"2024-01-30", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Mean number of injections", "timeFrame"=>"48 weeks", "description"=>"We will calculate the mean number of intravitreal ranibizumab injections at week 48."}], "secondaryOutcomes"=>[{"measure"=>"Change in BCVA", "timeFrame"=>"48 weeks", "description"=>"We will assess the participants' best-corrected distance visual acuity by ETDRS charts before and after the treatment at weeks 48."}, {"measure"=>"The mean change of central retinal thickness (CRT).", "timeFrame"=>"48 weeks", "description"=>"The participants' eyes will be fully dilated; the examiner will take the macular fovea as the center and perform a multi-directional, 6 mm-long, radial linear scan of the most prominent macular lesions and take linear scans in the same direction after the treatment. CRT is defined as the distance between internal limiting membrane and external limiting membrane, excluding the fluid under the retinal pigment epithelium (RPE)."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Traditional Chinese Medicine", "Ranibizumab", "Retinal Vein Obstruction"], "conditions"=>["Macular Cystoid Edema"]}, "descriptionModule"=>{"briefSummary"=>"The objective of this study was to investigate the efficacy and safety of traditional Chinese medicine (Jueling Mingmu Decoction) combined with ranibizumab in the treatment of macular edema with retinal vein obstructive.", "detailedDescription"=>"Compared to the sole intravitreal injection of ranibizumab, the combined use of traditional Chinese medicine with intravitreal ranibizumab aims to determine if it is more effective in alleviating macular cystoid edema secondary to retinal branch vein occlusion, leading to improved visual prognosis and potentially reducing the frequency of intravitreal drug injections."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Foveal center-involved macular edema (ME) lasting less than 9 months\n* Central Macular Thickness (CMT) greater than or equal to 250 μm\n* Best-Corrected Visual Acuity (BCVA) of 24-73 letters (20/40 to 20/320) in the study eye\n* Initial diagnosis with no prior treatments, such as laser therapy or intravitreal injections\n\nExclusion Criteria:\n\n* Presence of any additional macular pathology, such as age-related macular degeneration (AMD) or diabetic retinopathy (DR) affecting the macula\n* Concurrent serious conditions, such as cardiovascular diseases, liver, or kidney diseases\n* Concerns or doubts regarding treatment\n* Known allergies to the ingredients of the medication."}, "identificationModule"=>{"nctId"=>"NCT06234514", "acronym"=>"JQMMT+RA", "briefTitle"=>"Manage Macular Cystoid Edema With Retinal Vein Obstruction Using Traditional Chinese Medicine and Ranibizumab", "organization"=>{"class"=>"OTHER_GOV", "fullName"=>"Dongyang People's Hospital"}, "officialTitle"=>"Traditional Chinese Medicine and Ranibizumab in the Treatment of Macular Cystoid Edema Associated With Retinal Vein Obstruction.", "orgStudyIdInfo"=>{"id"=>"JQMMT"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Combination Therapy Group", "description"=>"During the initial month, the patient consumed Jueling Mingmu decoction daily for one month.\n\nPatients received monthly intravitreal injections of 0.5mg ranibizumab for the initial three months, followed by additional injections in the subsequent nine months for those who met eligibility criteria.", "interventionNames"=>["Drug: Jueling Mingmu decoction", "Drug: intravitreal injections of 0.5mg ranibizumab"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Intravitreal Ranibizumab Group", "description"=>"Patients received monthly intravitreal injections of 0.5mg ranibizumab for the initial three months, followed by additional injections in the subsequent nine months for those who met eligibility criteria.", "interventionNames"=>["Drug: intravitreal injections of 0.5mg ranibizumab"]}], "interventions"=>[{"name"=>"Jueling Mingmu decoction", "type"=>"DRUG", "description"=>"Jueling Mingmu decoction comprises stone cassia, grass cassia, Leonurus, chrysanthemum, red peony, Schizonepeta, poria, plantago, salvia miltiorrhiza, rice bud, licorice. It is designed to clear liver heat, promote diuresis, activate blood circulation, strengthen the stomach, and harmonize spleen functions.", "armGroupLabels"=>["Combination Therapy Group"]}, {"name"=>"intravitreal injections of 0.5mg ranibizumab", "type"=>"DRUG", "otherNames"=>["0.5mg ranibizumab"], "description"=>"Patients received monthly intravitreal injections of 0.5mg ranibizumab for the initial three months, followed by additional injections in the subsequent nine months for those who met eligibility criteria.", "armGroupLabels"=>["Combination Therapy Group", "Intravitreal Ranibizumab Group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"322100", "city"=>"Dongyang", "state"=>"Zhejiang", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Hangshuai Zhou", "role"=>"CONTACT", "email"=>"350589935@qq.com", "phone"=>"+8618867940019"}], "facility"=>"Dongyang People's Hospital", "geoPoint"=>{"lat"=>29.26778, "lon"=>120.22528}}], "centralContacts"=>[{"name"=>"Hongyan Wu", "role"=>"CONTACT", "email"=>"hongyanwu1982@163.com", "phone"=>"+13967490168"}], "overallOfficials"=>[{"name"=>"Guangjin Zhao", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Dongyang People's Hospital"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Dongyang People's Hospital", "class"=>"OTHER_GOV"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"doctor", "investigatorFullName"=>"Zhou Hangshuai", "investigatorAffiliation"=>"Dongyang People's Hospital"}}}}
