印度临床试验

概述

收录印度注册临床试验信息，涵盖基本信息、试验设计详情、招募信息、研究者信息、适应症、临床研发阶段、临床试验状态以及临床试验结果等内容，目前收录信息8万余条。

数据结构及样例

{
  "试验登记号":"CTRI/2025/04/084055",
  "印度官网链接":"https://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTI2OTI5",
  "登记日期":"2025-04-03", 
  "其他试验登记号":[""],
  "试验标题":"TO COMPARE BETWEEN 2 MM LOCKING MINIPLATES VERSUS 2.5 MM LOCKING MINIPLATE IN THE MANAGEMENT OF LOWER FRONT REGION FRACTURE TO FIND BETTER",
  "正式的科学名称":"COMPARATIVE EVALUATION OF 2 MM LOCKING MINIPLATES VERSUS 2.5 MM LOCKING MINIPLATE IN THE MANAGEMENT OF ANTERIOR MANDIBULAR FRACTURE",
  "试验简称":"",
  "国家/地区":"India（印度）",
  "结束日期":"",
  "最近更新日期":"2025-04-01",
  "试验持续时间":"0 years 0 months 0 days",
  "招募状态":"Recruiting（招募中）",
  "注册机构":"印度",
  "药品名称":"2 mm locking miniplates 4 hole and 6 hole with gap 2.5mm locking miniplate",
  "适应症":"26 Dentofacial functional abnormalities",
  "试验阶段":"Phase 3/Phase 4 Clinical（Ⅲ/Ⅳ期）",
  "试验类型":"Interventional（干预性研究）",
  "干预类型":["Medical procedure（医疗程序）","Diagnostic（诊断）","Prevention（预防性）","Dentistry（牙科）"],
  "试验设计":"Randomized, Parallel Group Trial",
  "盲法及设盲对象":"Investigator Blinded", 
  "摘要":"The objective of our research is to access the efficaciousness of 2.5mm 6 hole with gap locking plate and 2mm locking 4 hole with gap and 6 hole with gap,Primary Objectives:a. Fracture Stabilityb. Bite force using GnathodyamometerSecondary Objectives:1. Clinical Assessment:a. intraoperative tie fro incision till closuureb. painc. occlusiond. mental nervee. infection2. Radiographic Evaluation:a. Fracture  stabilityb. Hardware failurec. Post operative complications:- Malunion- Delayed union - Non-union",
  "试验方案":"序号 : 干预组别 : 干预措施 1 : Intervention,2 mm locking miniplates 4 hole and 6 hole with gap : a vestibular incision is given and fracture site is exposed followed by reduction of fracture by using 2mm 4 hole with gap locking miniplate and 6 hole with gap locking miniplate and then layerwise closure is done 2 : Comparator Agent,2.5mm locking miniplate : A vestibular incision is giev in the anterior mandibular fracture site followed by reduction in fracture using 2.5mm locking miniplate 6 hole with gap followed by layerwise closure"
  "主要疗效":[{"判定指标": "The study will evaluate intra-operative time, post operative pain(according to VAS4), bite force, fracture stability, occlusion, infection, paresthesia of mental nerve and radiological evaluation will include fracture stability, plate fracture and post operatively malunion, delayed union and non union.", "时间节点": "1ST POST OPERATIVE DAY, 7TH POST OPERATIVE DAY, 14T POST POST OPERATIVE DAY, 1ONTH, 3 MONNTHS AND 6 MONTHS"}],
  "次要疗效":[{"判定指标": "efficacy of the plates & the better anatomical reduction), bite force, fracture stability, occlusion, infection, paresthesia of mental nerve and radiological evaluation will include fracture stability, plate fracture and post operatively malunion, delayed union and non union.", "时间节点": "1ST DAY, 3RD DAY, 7TH DAY, 14TH DAY, 1 MONTH, 3 MONTHS AND 6 MONTHS"}], 
  "入组人数":"26",
  "年龄范围":"18 Year(s) - 50 Year(s)",
  "性别":"Both",
  "入选标准":"American Society of Anaesthesiologists (ASA) Group I & II patients having isolated anterior mandibular fractures Age 18 years - 50 years Patient willing to give informed consent",
  "排除标准":"Current exclusion criteria as of 24/11/2021:1. Age <18 years.2. Pregnant or lactating women.3. Known intolerance or contraindications to beta-blockers including asthma",
  "首例受试者入组日期":"2025-05-19",
  "申办单位":"SARDAR PATEL POST GRADUATE INSTITUTE OF DENTAL AND MEDICAL SCIENCES",
  "合作单位":"",
  "联系人信息":"序号 : 联系人类别 : 姓名 : 联系方式 1 : 公众联系人 : DR SHUBAMOY MONDAL : 7800899044;dr.shubhamoy@gmail.com 2 : 科学联系人 : DR SHUBAMOY MONDAL : 7800899044;dr.shubhamoy@gmail.com",
   "临床试验结果":"序号 : 文献内容 : 文献链接 1 : 点击查看 : https://pubmed.ncbi.nlm.nih.gov/00000000/（示例数据）",
 }