A randomized, open label, comparative, clinical study to evaluate the efficacy and safety of TRUBLISS PAIN RELIEF GEL in patients with musculo-skeletal and joint pain disorders
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 1. Time to onset of relief of pain [Time frame: 0-120 minutes post dose]
研究概览
简要总结
Participants will be randomized into two groups of 15 each:
Arm 1: Participants with musculoskeletal and joint pain will use TRUBLISS PAIN RELIEF GEL twice daily for 2 weeks.
Arm 2: Participants with musculoskeletal and joint pain will use Volitra Gel twice daily for 2 weeks.
Primary Endpoints
-
Time to pain relief onset (0-120 minutes post-dose).
-
Time to onset of cooling/warmth/tingling/burning sensations (0-120 minutes post-dose).
-
Time to complete pain relief (0-120 minutes post-dose).
-
Pain reduction at rest (measured at various intervals up to 8 hours post-dose).
-
Pain reduction during movement (measured at various intervals up to 8 hours post-dose).
-
Change in pain intensity from baseline to 2 weeks (measured by Pain VAS Scale).
-
Time between pain relief onset and need for second application (0-24 hours).
-
Overall satisfaction with pain relief (7-point Likert scale from Day 1 to Day 14).
-
User perceptions of ease of application, stickiness, greasiness, and spread ability (5-point Likert scale from Day 1 to Day 14).
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Number of patients requiring rescue medication (Day 1 to Day 14).
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Changes in laboratory parameters for arthritis (C-Reactive Protein, ESR) from baseline to 2 weeks.
-
Quality of life changes (Short Form Health-12) from baseline to 2 weeks.
Secondary Endpoint
Safety and tolerability, assessed by adverse events (AEs) and serious adverse events (SAEs) during the study period and brief clinical examinations.
Data will be compared between TRUBLISS PAIN RELIEF GEL and Volitra Gel.
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 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients of either sex aged above 18 years.
- •Patients who can 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.
- •3.Patients who have been diagnosed with acute and chronic localized musculoskeletal pain and joint pain (arthritis) disorders.
排除标准
- •Women of childbearing 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
- •Known allergy to compounds of investigational product.
- •Participation in an investigational drug trial in the 30 days prior to the screening visit.
- •Patients of vulnerable group (children, lactating mother, elderly greater than 80 years, handicapped, seriously ill, mentally challenged).
- •7.History of drug or alcohol abuse during the last 6 months.
结局指标
主要结局
1. Time to onset of relief of pain [Time frame: 0-120 minutes post dose]
时间窗: Baseline and Day 14
2. Time to onset of cooling/warmth/tingling/burning sensation
时间窗: Baseline and Day 14
3. Time to achieve complete relief of pain
时间窗: Baseline and Day 14
4. Reduction in pain score on numeric pain rating scale
时间窗: Baseline and Day 14
7. Time interval between onset of pain relief and the need for second application of test/ comparator product for pain relief
时间窗: Baseline and Day 14
8. Changes from base line to 2 weeks in following laboratory parameter(s) for arthritis patients: a. C Reactive Protein and b.ESR
时间窗: Baseline and Day 14
9. Subject’s overall satisfaction for pain relief and User perception
时间窗: Baseline and Day 14
10. Number of patients requiring rescue medication
时间窗: Baseline and Day 14
11.Changes from base line to 2 weeks post dose in Quality of life- Questionnaires
时间窗: Baseline and Day 14
次要结局
- To demonstrate safety and tolerability of study product by Clinical AEs (If any)
研究者
Dr M Sakthi Balan MBBS MD
Ki3 Private Limited