Evaluation of Safety and Efficacy of Jan Aushadhi Versus Branded Generic Formulations of Ibuprofen and Aceclofenac-Paracetamol in Odontogenic Pain: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
研究概览
简要总结
This is a prospective randomized clinical trial designed to evaluate the safety efficacy and cost effectiveness of Jan Aushadhi supplied non steroidal anti inflammatory drugs compared with branded generic formulations in patients with odontogenic pain. A total of one hundred and sixty participants will be randomly allocated into four groups. Participants will receive either Jan Aushadhi or branded generic ibuprofen or aceclofenac paracetamol combination as per standard dosing for five days. Pain intensity will be assessed using the Visual Analog Scale at baseline and Day 5 of treatment. Inflammatory biomarkers including salivary prostaglandin E2 salivary nitrite serum C reactive protein and salivary total protein will be measured before and after treatment. Safety will be evaluated by monitoring adverse drug reactions and changes in hepatic renal and hematological parameters. A pharmacoeconomic analysis will be performed to compare cost effectiveness cost benefit and budget impact of Jan Aushadhi and branded generic formulations in the management of odontogenic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients diagnosed with Pulpitis and Acute apical periodontitis having VAS (Visual Analog Scale) pain score more than or equal to 4 (moderate to severe pain) at baseline (Day 0).
排除标准
- •1.Patients requiring surgical intervention under general anaesthesia or other medications except NSAID for treatment of dental pathology 2.Patients with odontogenic -like pain (e.g., referred pain, neuralgia) without a dental pathology 3.Patients with past history of allergic reactions or hypersensitivity to NSAIDs 4.Pregnant or Lactating women 5.Patients currently on chronic NSAIDs (for cardiovascular disease), systemic corticosteroids, opioids, anticoagulants, or immunosuppressants within last 2 months 6.History of Gastrointestinal disorders (e.g. Peptic ulcer disease, bleeding), bronchial asthma, or respiratory distress 7.History of using any NSAID or antibiotics within 2 weeks before the initial OPD visit 8.History of alcohol use disorder or substance abuse.
研究者
Dr Bala Ashwathy R M
SRM Medical College Hospital & Research Centre, SRM Institute of Science & Technology (SRMIST)