CTRI/2021/04/032710尚未招募2/3 期
An Open–Label, Two Arm Clinical Study to Evaluate the Efficacy and Safety of RUMA Spray in Acute Musculoskeletal Pain and Acute Sports Injury Pain Relief
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Time required for the onset of relief.
研究概览
简要总结
| Composition of RUMA |
Bakuchi (Psoralea corylifolia)
Maricha (Piper nigrum)
Sarala (Pinus longifolia)
Gandhapura Taila (Gaultheria fragrantissima)
Tila (Sesamum indicum)
Karpura (Cinnamomun camphora)
Pudina satva (Mentha arvensis)
Ajmoda satva (Carum copticum)
This study is designed to evaluate the safety and efficacy of Pain relief spray and get quick relief in common Acute musculoskeletal pain like back pain, shoulder pain, knee pain sprain and strain and any Acute sports and traumatic injuries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects of either gender aged ≥
- •â‰¤65 years. 2.Subjects with Grade I and Grade II muscular sprains and joint pain. 3.Subjects suffering from Common musculoskeletal conditions.
- •Back ache, joints pain (Wrist, elbow, shoulder, ankle, Knee, neck pain, sprains and strains / Sports and traumatic injuries. 4.Subjects willing to sign informed consent and follow with the schedule. 5.Subjects who have not participated in similar kind of study in last 4 weeks.
排除标准
- •1.subjects suffering from auto-immune disorders, spastic disorders, genetic disorders and severe traumatic conditions.
- •2.Any evidence or history of hypersensitivity to any of the components in the RUMA Spray 3.Any known skin disorder or presence of open wounds.
- •4.subjects who are taking any additional topical therapy or systemic NSAIDs. 5.Clinical diagnosis of bruises, trauma, muscle damage.
- •6.subjects with raw wounds, sutures, fractures and hematoma.
- •7.Pregnant or lactating women/women not willing to follow adequate standard contraceptive measures.
结局指标
主要结局
Time required for the onset of relief.
时间窗: quick relief
Time required for complete relief.
时间窗: quick relief
Time required for next successive application.
时间窗: quick relief
次要结局
- Improvement in the Visual Analogue Scale scoring on the successive application as compared to baseline.(Incidence of any adverse events during study.)
研究者
研究点 (2)
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