跳至主要内容
临床试验/CTRI/2011/091/000001
CTRI/2011/091/000001已完成3 期

A randomized, two arm, open label, active controlled, multicentric clinical study to evaluate the efficacy and safety of a topical formulations of diclofenac (2.32% w/v solution) with Methyl Salicylate 10% w/v and Menthol 5% w/v versus a topical Diclofenac Gel (1.16% w/w) with Methyl Salicylate 10% w/w and Menthol 5% w/w in acute low back ache and sprains.

Troikaa Pharmaceuticals Ltd0 个研究点目标入组 140 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
已完成
入组人数
140

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.Male or females patients aged 18- 70 years.
  • 2.Patients with acute low back ache or pain following sprains or sports injuries of duration not more than 2 days
  • 3.Patients with at least moderate pain of VAS ≥ 4

排除标准

  • 1.Patients below 18 years or above 70 years of age.
  • 2.Hypersensitivity to aspirin/ NSAID or any other component of the formulation
  • 3.Any contraindication to diclofenac / NSAIDs
  • 4.Patients with skin wounds, open injuries or other conditions of broken skin at the site of proposed application
  • 5.Concomitant skin disease at site of application
  • 6.Use of another topical product at application site
  • 7.Pregnant women and lactating mothers
  • 8.Women of child bearing age not practicing or not willing to use contraceptive
  • 9.Unwilling patients.
  • 10.Patients already on oral NSAIDs/ analgesics.
  • 11.Patients requiring hospitalization or other treatment for pain.

研究者

相似试验