A Randomized, Multi-Centric, Open Label, Comparative, Clinical Study To Evaluate The Efficacy and Safety Of Trumove Gel In Patients with Musculo-Skeletal and Joint Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 3. Time to achieve complete relief of pain
研究概览
简要总结
- The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study.
- 30 Participants will be randomized into 2 groups with 15 in each group.
- Arm 1 - Trumove Gel: 15 study participants
- Arm 2 - Volitra Gel: 15 study participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex aged above 18 years.
- •Patients who are able to understand written and/or verbal instructions and are ready to comply with all study requirements with a willingness to participate and give written informed consent voluntarily.
- •Patients who had been diagnosed with acute and chronic localized musculoskeletal pain and joint pain (arthritis) .
排除标准
- •Women of child bearing potential who are either unwilling or unable to use an acceptable method of birth control to avoid pregnancy during the study period.
- •Subject with active skin lesions or other skin diseases.
- •Subject with history of uncontrolled diabetes
- •Subject with history of Periarthritis, rheumatoid arthritis
- •Known allergy to compounds of investigational product.
- •Participation in an investigational drug trial in the30 days prior to the screeningvisit.
- •Patients of vulnerable group (children, lactating mother, elderly >80 years,handicapped, seriously ill, mentally challenged).
- •History of drug or alcohol abuse during the last 6 months.
结局指标
主要结局
3. Time to achieve complete relief of pain
时间窗: Day 1 [Time frame: 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes and hourly upto 8 hours post dose] , day 7 to day 10
4. Reduction in pain score on numeric pain rating scale AT REST and during MOVEMENT
时间窗: Day 1 [Time frame: 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes and hourly upto 8 hours post dose] , day 7 to day 10
6. Time interval between onset of pain relief and the need for second application of test / comparator product for pain relief
时间窗: Day 1 [Time frame: 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes and hourly upto 8 hours post dose] , day 7 to day 10
7. Subjects overall satisfaction for pain relief on a 7- point Likert Satisfaction scale
时间窗: Day 1 [Time frame: 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes and hourly upto 8 hours post dose] , day 7 to day 10
2. Time to onset of cooling/warmth/tingling/burning sensation
时间窗: Day 1 [Time frame: 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes and hourly upto 8 hours post dose] , day 7 to day 10
1. Time to onset of relief of pain
时间窗: Day 1 [Time frame: 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes and hourly upto 8 hours post dose] , day 7 to day 10
5. Changes in joint/Musculo skeletal pain intensity measured by Pain VAS Scale (0-100 mm)
时间窗: Day 1 [Time frame: 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes and hourly upto 8 hours post dose] , day 7 to day 10
8.User perception was assessed with a 5- point Likert Satisfaction scale
时间窗: Day 1 [Time frame: 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes and hourly upto 8 hours post dose] , day 7 to day 10
9. Number of patients requiring rescue medication
时间窗: Day 1 [Time frame: 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes and hourly upto 8 hours post dose] , day 7 to day 10
10. Changes in C Reactive Protein and ESR
时间窗: Day 1 [Time frame: 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes and hourly upto 8 hours post dose] , day 7 to day 10
11. Changes in Quality of life Questionnaires (Short Form Health-12) and the WOMAC Pain score and McGill Pain Questionnaire for pain intensity.
时间窗: Day 1 [Time frame: 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes and hourly upto 8 hours post dose] , day 7 to day 10
次要结局
- Adverse events and serious adverse events during the study period(Brief clinical examination)