A single-centre, randomized, open-label, active controlled, investigator initiated clinical trial evaluating the efficacy and safety of Dynapar QPS for the treatment of post-traumatic swelling / inflammation
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- % change in swelling at various time points from baseline is the main outcome/s in this study which is used to determine the effects of the both intervention/s (Diclofenac Diethylamine (Dynapar QPS) 4.64% w/v Topical Solution manufactured by Troikaa Pharmaceuticals Ltd. versus Marketed product of Diclofenac Diethylamine 1.16% w/w Topical Gel). Moreover this is an exploratory trial hence data from 50 patients will be enough to estimate difference between two interventions.
研究概览
简要总结
Pain, swelling, and inflammation are common symptoms that can occur after a non-surgical post-traumatic event or blunt trauma. These symptoms are a natural part of the body’s healing process and are typically seen within the first 24 hours after the injury. During this initial stage of inflammation, it is important to manage these symptoms to promote healing and provide relief to the patient.
Post-traumatic swelling and inflammation are common symptoms following injuries or trauma. Several topical formulations of diclofenac have been studied for their effectiveness in treating these symptoms. These formulations include solutions, emulsion gels, controlled-release pellets, and polymeric film coatings. These formulations have shown promising results in controlled drug release, providing sustained relief from swelling and inflammation. The effectiveness of topical formulations of diclofenac in treating post-traumatic swelling and inflammation in humans has been studied. Based on the available research, topical formulations of diclofenac have shown to be effective in reducing post-traumatic swelling and inflammation in humans. Comparative pharmacokinetics and bioavailability study of percutaneous absorption of diclofenac from two topical formulations containing drug as a solution or as an emulsion gel. Additionally, comparative studies have shown that topical diclofenac has a similar short-term effect in reducing pain and improving function compared to oral forms of the drug for symptoms of osteoarthritis in a single knee.
Non-surgical trauma, such as sprains, strains, and bruises, often results in pain, swelling, and inflammation. Dynapar QPS is a novel topical formulation of diclofenac diethylamine, a nonsteroidal anti-inflammatory drug that can be applied directly to the affected area. It works by inhibiting the production of prostaglandins, which are responsible for inflammation and pain. Using topical diclofenac in non-surgical trauma can help alleviate pain, reduce swelling, and decrease inflammation, providing localized relief without the need for oral medications or invasive procedures. Dynapar QPS that can be applied directly to the affected area and is known to have analgesic and anti-inflammatory properties. It is also well-tolerated and safe for topical use, with minimal risk of systemic side effects. Additionally, topical diclofenac has been extensively studied and proven to be effective in managing various types of acute and chronic pain, including musculoskeletal pain, joint pain, and soft tissue injuries. Overall, topical diclofenac is a safe and effective option for managing pain, swelling, and inflammation in non-surgical trauma cases. Using topical diclofenac in non-surgical trauma can provide targeted relief of pain, swelling, and inflammation without the need for oral medications or invasive procedures. It is a convenient and practical option for patients who prefer topical treatments or those who may have contraindications to systemic medications. Additionally, topical diclofenac has been shown to have a faster onset of action compared to oral medications, providing quicker relief to patients.
This study has been designed to observe the effectiveness of Dynapar QPS over the marketed product of Diclofenac Diethylamine 1.16% w/w Topical Gel in the treatment of post traumatic swelling / inflammation
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 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender in the age group of 18 years and above
- •Patients presenting with any type of fresh impact injuries (blunt, traumatic soft tissue injuries and contusions) with localised swelling / inflammation.
- •Patients willing to give written informed consent prior to participation in the study
- •Able to understand the study procedures and the use of the pain scales and to communicate meaningfully with the study observer and staff.
- •The female subjects who are of non-childbearing potential or of childbearing potential, who are non-pregnant.
排除标准
- •Patients with known hypersensitivity or contraindication to study drugs or any of the excipients.
- •Patient presenting with a fracture, infection, open wound or wound requiring hospitalization or a surgical procedure.
- •Patient receiving any digestive enzymes (like Trypsin / Chymotrypsin / Serratiopeptidase) or any other topical preparation.
- •Patient requiring antibiotics or corticosteroids.
- •Pregnant and/or lactating women.
- •Patient has participated in another clinical study (investigational or marketed product) within 30 days prior to screening.
- •Patients, for any reason not considered to be suitable candidate by the investigator.
结局指标
主要结局
% change in swelling at various time points from baseline is the main outcome/s in this study which is used to determine the effects of the both intervention/s (Diclofenac Diethylamine (Dynapar QPS) 4.64% w/v Topical Solution manufactured by Troikaa Pharmaceuticals Ltd. versus Marketed product of Diclofenac Diethylamine 1.16% w/w Topical Gel). Moreover this is an exploratory trial hence data from 50 patients will be enough to estimate difference between two interventions.
时间窗: 3 Days
次要结局
- 1. Pain intensity difference on VAS (PID vas) from baseline at 15 min, 30 min, 45 min, 1 hour, 3 hour and 6 hour after first dose and at 1 hour after each subsequent doses (from Day 0 to Day 3) from baseline.(2. Time to first rescue)
研究者
Dr Pratik Vinchhi
Parth Hospital