CTRI/2024/01/062033招募中4 期
Evaluation of Efficacy and safety of aceclofenac plus paracetamol plus serratiopeptidase combination after Impacted lower third molar surgery: A randomized, double blind comparison with aceclofenac plus paracetamol combination
试验速览
- 阶段
- 4 期
- 状态
- 招募中
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.Patient undergoing surgery for extraction of lower 3rd molar
- •2. Patients having first and second molars on the side of the surgery
- •3. Patients with ASA Grade 1
- •4. Patients with no history of oral surgical interventions during the past 3 weeks
- •5. Patients able to understand and willing to fully comply with study procedures and restrictions.
- •6. Patient ready to give informed consent to participate in the study
排除标准
- •1. Patients with Type 1 diabetes / Type 2 Diabetes
- •2. Patients with hypertension (SBP=140 mmHg and/or DBP =90 mmHg)
- •3. Patients with genetically transmitted bleeding disorders
- •4. Patients with pathologic changes in teeth or the surrounding area
- •5. Patients with extraoral or intraoral swelling with cellulitis in the area of surgery
- •6. Patients with history of systemic illness
- •7. Patients with respiratory depression, asthma or other breathing problems
- •8. Patients with cardiac disease
- •9. Patients with previous or present gastric ulcers
- •10. Patients with abnormal renal function (serum creatinine =1.5 mg/dL for male and =1.4 mg/dL for female)
- •11. Patients with abnormal liver function (SGOT, SGPT, total bilirubin, or alkaline phosphatase >2.5 times the upper limit of normal values) or active or chronic liver disease
- •12. Patients with significantly abnormal counts in hematology, diseases of blood or hematopoietic organs or female patients with Hb <10 g/dL or male patients with Hb <12 g/dL
- •13. Patients with chronic gastroparesis, active gastrointestinal disorders (gastric and duodenal ulcer)
- •14. Patients with malignancy and planned radiological examinations requiring administration of contrasting agents
- •15. Patients with malabsorption or pancreatitis
- •16. Patients with dementia or other cognitive impairment prohibiting informed consent
- •17. Patients with known history of HIV1/HIV2/Hepatitis B or C infection or syphilis infection
- •18. Patients with any other clinically significant abnormalities/disease which may or may not interfere with assessment of disease under evaluation
- •19. Patients suspected of COVID-19 infection
- •20. Patients who have taken analgesic or anti-inflammatory drugs within 48 hours before surgery
- •21. Patients with chronic use of non-steroidal anti-inflammatory agents
- •22. Patients receiving concomitant medications known to have an interaction with study medications
- •23. Patients receiving anti-coagulant drugs
- •24. Patients with known history of hypersensitivity to study drugs or drugs of same chemical class or any other ingredient of the study formulations or with history of any severe allergic disease
- •25. Patients with other substance abuse within last 1 year
- •26. Patients consuming alcohol more than 21 units /week
- •27. Patients on another investigational agent / device or participated in a clinical trial within the last 30 days prior to enrollment.
- •28. Pregnant or lactating women
- •29. Women of childbearing potential not practicing contraception.
研究者
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