A randomized double-blinded comparative efficacy study of TF1 and TF2 in Adult Subjects with exercise induced acute musculoskeletal pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean change in SPID6 hours
研究概览
简要总结
The potential participants who are willing to provide a written informed consent form will be asked to come for screening. The main inclusion criteria for the screening procedure will be an NRS score of 5 or above.
McGill –SFQ will also be taken at the screening which will be considered as the baseline score. The participants will then be randomized into either of the two groups. Post dose for every 1hr interval up to 6hrs the participant will be asked to indicate their resting pain intensity and pain relief, using the NRS and PRS scale. McGill-SF questionnaire will be taken at the baseline and end of the study (post 6 hr) to evaluate quality of pain.
If there is need for rescue medication, then the subject will record pain intensity before taking rescue medication and the consumption recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult subject, Male or female between 18-65 years of age.
- •A score of 5 or above on the NRS.
- •Subjects having exercise induced acute musculoskeletal pain which occurred within 24 hours before presentation.
- •Willing to give voluntary informed consent.
排除标准
- •Subject with acute muscle spasms who need parenteral therapy, surgery or hospital admission for management, painful uncomplicated acute soft tissue injury of the upper or lower extremity, including acute injuries of ligaments, tendons, or muscles.
- •Subjects with Grade 2 & 3 sprain or strain or muscle cramps due to dehydration.
- •Pain originating from bone.
- •Subjects with known history of osteoarthritis and rheumatoid arthritis.
- •Subjects with open wounds infected skin or other conditions of broken skin, skin affected by infection with inflammations at the site of proposed action.
- •Use of any oral or topical analgesic, antipyretic, sedative or anti-inflammatory treatment, Use of any topical products, including topical medications, sunscreens, lotions, moisturizers, and cosmetic products at the site of pain within 1 week prior study or during the study.
- •Any kind of neuralgic pain, headache and/or chronic pain Previous adverse reaction or known allergy to herbal, NSAID, steroids or any other severe food allergies.
结局指标
主要结局
Mean change in SPID6 hours
时间窗: Intervals of 1hr - 0,1,2,3,4,5,6 hours.
次要结局
- Mean change in TOTPAR6 hours(Intervals of 1hr - 0,1,2,3,4,5,6 hours.)
- Mean change in Perceived pain relief & Meaningful pain relief using stop watch.(Time to pain relief starting from 0hr & censored at 6hr.)
- Mean change in McGill Short Form Questionnaire(Baseline & end of 6hr.)