CTRI/2022/03/041099已完成3 期
An Open label, multicenter, randomized, Parallel, placebo controlled, safety and efficacy study of Tranexamic acid spray 10% w/v in patients undergoing Dental Extraction.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or non-pregnant females aged 18 years and above with a Body Mass Index (BMI) of at least 18.5 Kg/m2.
- •2.Subjects undergoing extraction of any 3rd molar teeth of four quadrants of the mouth.
- •3.All subjects willing to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits.
- •4.Extraction sites do not require primary closure or suturing
- •5.Subjects who are willing and able to take part and attend all required study visits, able to understand the information given to them and give written consent.
- •6.Along with normal subjects, subjects with control type diabetics (HbA1C levels less than 7) will be included in the study.
- •7.Along with normal subjects, subjects with controlled hypertension ( < 140/90mmHg) will be included in the study.
排除标准
- •1.Patients with personal and family history that could affect correct haemostasis. i.e subjects with Hemophilia conditions and Subjects with any clinically-significant coagulation disorder including deficiencies in any of coagulation factors, thrombocytopenia and vascular purpura.
- •2.Hb < 10 and Platelet count < 50,000
- •3.Hypersensitivity to tranexamic acid and any of the ingredients
- •4.In patients with subarachnoid hemorrhage, due to risk of cerebral edema and cerebral infarction
- •5.In patients with active intravascular clotting
- •6.Patients with thrombosis with concomitant use of Factor IX
- •7.Patients with history of visual disturbances.
- •8.Patients with history of epilepsy or seizures or convulsions
- •9.Scheduled to undergo a surgical procedure other than 3rd molar tooth extractions
- •10.Any abnormal findings during clinical or radiographic examination. Example: Patients with ankylosed or root morphological alterations that may complicate the procedure.
- •11.Patients with renal dysfunction /hepatic dysfunction.
- •12.Patients with uncontrolled diabetes (Haemoglobin A1c above 7.0%).
- •13.Patients with cardiovascular disorders such as Ischemic Heart Disease, Arrhythmias, Heart Failure and endocarditis
- •14.Patients with history hypertensive 140/90mmHg above.
- •15.Patients with history of uncontrolled thyroid abnormalities.
- •16.Patients who were transferred more than six hours after the trauma.
- •17.Immunosuppressive conditions such as AIDS, cancer or radiation therapies.
- •18.Pregnant/Lactating women where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
- •19.Patients who are undergoing bisphosphonate therapy
- •20.Subjects with positive COVID-19 results
研究者
相似试验
已完成
1 期
Triamcinolone Hexacetonide (THA) 20mg/ml injection in patients with knee osteoarthritis.CTRI/2020/12/029771Abbott Healthcare Pvt Ltd44
进行中（未招募）
不适用
A Study to Assess the Efficacy and Safety of H-15 Soft Gel Capsules and Sallaki tablets in Comparison with Standard of Care treatment in Patients Suffering from Mild to Moderate Bronchial AsthmaCTRI/2021/11/038335Gufic Biosciences Limited
进行中（未招募）
1 期
Bendamustine, thalidomide and dexamethasone in relapsed/refractory myelomaEUCTR2010-021451-12-GBniversity of Leeds95
已完成
不适用
Comparison of concomitant drug confirmation methods in community pharmacies for patients using multiple drugsPatients prescribed diuretics and renin-angiotensin system inhibitors (angiotensin converting enzyme inhibitorsACEI or angiotensin II receptor blockersABR)JPRN-UMIN000047550Shiga Pharmaceutical Association Kaiei Pharmacy80
已完成
3 期
A clinical trial to evaluate the clinical effects on safety and efficacy of Kremezin® on suppression of progression of Chronic Renal Failure.CTRI/2010/091/000349G Life Sciences India Pvt Ltd232