跳至主要内容
临床试验/CTRI/2024/08/072363
CTRI/2024/08/072363尚未招募2 期

A randomized, double-blind comparative clinical study evaluating the impact of an investigational product in managing post-operative inflammation in orthopedic surgeries.

Advanced Vital Enzymes P. Ltd. (Advenza)3 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2024年8月19日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
105
试验地点
3
主要终点
1.Changes in inflammation score (edema) on VRS.

研究概览

简要总结

Surgical wounds, especially in co-morbid conditions, pose significant challenges in management. The growing use of multiple medications in healthcare highlights their relevance, yet applying them effectively in surgical wound care is comparable to "separating diamonds from the ore." Despite efforts to unravel wound molecular intricacies and explore the impact of various molecules, a definitive, evidence-based therapy for wounds remains elusive. The recent pandemic has exacerbated healthcare challenges due to limited access to facilities. In addressing clinical challenges, a clear understanding of protease enzymes is essential, offering clinicians better options for selecting appropriate drug regimens.

This study is crucial as effective management of post-operative inflammation in orthopedic surgeries is essential for optimizing patient recovery and reducing complications. Evaluating an investigational test product through rigorous clinical trials can potentially introduce safer and more effective treatment options. Improved inflammation control could lead to shorter hospital stays, decreased healthcare costs, and enhanced patient satisfaction. Addressing these aspects contributes significantly to advancing orthopedic surgical care and patient outcomes. Thus, the aim of the study was to compare the short-term efficacy and tolerability of an oral enzyme supplement (EnMax) with the placebo and similar market product post –operative patients.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
25.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients with 25-50 years of age (both inclusive);2.Patients electively posted for orthopedic surgery;3.Patient without any suspected or confirmed infection and receiving treatment for same;4.Willing to give informed consent for the study.

排除标准

  • 1.Patients undergoing emergency surgery; 2.Patients receiving immunosuppressive agents; 3.Allergy, sensitivity, or contraindication to any interventional product; 4.Patient with hepatic and or renal disorder, bleeding disorders, menorrhagia, hematuria and hematemesis; 5.History of gastric ulcer or bleeding diathesis; 6.Currently receiving cytotoxic therapy, or have received it within the last three months; 7.Patients treated with any investigational drug in the preceding 4 weeks; 8.Female patients with a positive pregnancy test or lactating; 9.Patients with uncontrolled diabetes mellitus or any other metabolic disorder; 10.Seriously ill and moribund patients with complications; 11.Patients unable to comply with the treatment regimen; 12.History of use of recreational drugs within 12 months before receiving the study drugs; 13.Patients with any other condition that, in the opinion of the investigator, does not justify the inclusion of the patient in the study.

结局指标

主要结局

1.Changes in inflammation score (edema) on VRS.

时间窗: At Day 1, Day 3, Day 6 and Day 8.

2.Changes in pain score on VAS.

时间窗: At Day 1, Day 3, Day 6 and Day 8.

次要结局

  • 1.Changes in inflammatory biomarkers CRP and ESR.(2.Changes in requirement of analgesic as a rescue medication.)

研究者

发起方
Advanced Vital Enzymes P. Ltd. (Advenza)
申办方类型
Other [nutraceutical]
责任方
Principal Investigator
主要研究者

Dr Hrishikesh Patkar

Ayushri Multispeciality Hospital

研究点 (3)

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