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
- 入组人数
- 556
- 试验地点
- 32
- 主要终点
- 1.Mean swelling of face by measuring distance in millimeters from the bottom edge of the earlobe to the midpoint of symphysia hirota (chin; DHS), distance in millimeters from bottom edge of the earlobe to external angle of mouth (horizontal distance to the corner of mouth; DHC), distance in millimeters from the palpebral outboard angle to gonial angle (verticle distance; DV)
研究概览
简要总结
This is a multi-centric, double-blind, parallel study. A total of 556 patients with age 18-45 years that require third molar surgery are screened for the study. There will be a pre-operative period, baseline, and post-operative (baseline) period. All patients will be given a capsule of Amoxicillin + Clavulanic acid (500mg + 125mg) thrice daily for 5 days post-operatively to prevent infection of the surgical site. Any additional antibiotics or antacids (PPIs or H2 blockers) will be prescribed at the discretion of the investigator. Patients satisfying inclusion/exclusion criteria are randomized at post-surgery into a 1:1 ratio to receive one of the following therapies twicedaily for 7 days:
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FDC of Aceclofenac 100 mg + Paracetamol 325 mg + Serratiopeptidase 15 mg tabletsand matching placebo of Aceclofenac 100 mg + Paracetamol 325 mg FDC tablets
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FDC of Aceclofenac 100 mg + Paracetamol 325 mg tablets and matching placebo ofAceclofenac 100 mg + Paracetamol 325 mg + Serratiopeptidase 15 mg FDC tab
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient undergoing surgery for extraction of lower 3rd molar
- •Patients having first and second molars on the side of the surgery
- •Patients with ASA Grade 1
- •Patients with no history of oral surgical interventions during the past 3 weeks
- •Patients able to understand and willing to fully comply with study procedures and restrictions.
- •Patient ready to give informed consent to participate in the study.
排除标准
- •Patients with Type 1 diabetes / Type 2 Diabetes
- •Patients with hypertension (SBP≥140 mmHg and/or DBP ≥90 mmHg)
- •Patients with genetically transmitted bleeding disorders
- •Patients with pathologic changes in teeth or the surrounding area
- •Patients with extraoral or intraoral swelling with cellulitis in the area of surgery
- •Patients with history of systemic illness
- •Patients with respiratory depression, asthma or other breathing problems
- •Patients with cardiac disease
- •Patients with previous or present gastric ulcers
- •Patients with abnormal renal function (serum creatinine ≥1.5 mg/dL for male and ≥1.4 mg/dL for female)
- •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
- •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
- •Patients with malignancy and planned radiological examinations requiring administration of contrasting agents
- •Patients with malabsorption or pancreatitis
- •Patients with dementia or other cognitive impairment prohibiting informed consent
- •Patients with known history of HIV1/HIV2/Hepatitis B or C infection or syphilis infection
- •Patients with any other clinically significant abnormalities/disease which may or may not interfere with assessment of disease under evaluation
- •Patients suspected of COVID-19 infection
- •Patients who have taken analgesic or anti-inflammatory drugs within 48 hours before surgery
- •Patients with chronic use of non-steroidal anti-inflammatory agents
- •Patients receiving concomitant medications known to have an interaction with study medications
- •Patients receiving anti-coagulant drugs
- •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
- •Patients with other substance abuse within last 1 year
- •Patients consuming alcohol more than 21 units /week
- •Patients on another investigational agent / device or participated in a clinical trial within the last 30 days prior to enrollment.
- •Pregnant or lactating women 29.
结局指标
主要结局
1.Mean swelling of face by measuring distance in millimeters from the bottom edge of the earlobe to the midpoint of symphysia hirota (chin; DHS), distance in millimeters from bottom edge of the earlobe to external angle of mouth (horizontal distance to the corner of mouth; DHC), distance in millimeters from the palpebral outboard angle to gonial angle (verticle distance; DV)
时间窗: at post-operative day 7
次要结局
- mean swelling (Facial measurements; DHS, DHV and DV) between treatment groups(at post-operative Day 1, 2, 3 and 5 from baseline)
- mean pain intensity between treatment groups(at post-operative Days 1, 2, 3, 5, and 7)
- mean swelling (based on individual distance; DHS, DHC, and DV) between treatment groups(at post-operative Day 1, 2, 3, 5 and 7 from baseline)
- trismus between treatment groups(at post-operative Days 1, 2, 3, 5, and 7.)
- mean cheek swelling between treatment groups(at post-operative days 1, 2, 3, 5, and 7.)