A prospective, randomized, double-blind, single-center, placebo-controlled, 2 arm clinical study to assess efficacy, safety and tolerability of topically administered NKAFE cream in supporting muscle and joint comfort.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Evaluation of change in pain score at rest (Visual Analog Scale), change in pain score in motion (Visual Analog Scale), muscle stiffness measured by Numerical Rating Scale (NRS), severity of pain on a 5-point rating scale of very severe, severe, moderate, mild and none, evaluation of severity of stiffness on a 5-point rating scale of very severe, severe, moderate, and mild and none.
研究概览
简要总结
This is a prospective, randomized, double-blind, single-center, placebo-controlled, 2 arm parallel clinical study. Male and female participants with acute or chronic localized musculoskeletal pain or musculoskeletal discomfort will be enrolled in the study. A total of 22 subjects, including approx. 10% dropout will be screened and randomly assigned in 1:1 ratio to NKAFE cream or Placebo cream group i.e. 11 participants in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Males or females aged of 19-65 years (both inclusive).
- •Participant with acute or chronic localized musculoskeletal pain or musculoskeletal discomfort.
- •Participant willing to give written informed consent.
- •Participant willing to come for visits at the site as per protocol.
- •Participant willing to use the investigational product as instructed per protocol.
排除标准
- •Pregnant, lactating women.
- •Use of any topical agents on the affected area within 3 days of screening or enrolment.
- •Subject with active skin lesions or skin disease or with cutaneous manifestations of systemic illnesses.
- •Subject with active cancer, spinal cord lesions or spine surgery.
- •Subject with history of alcohol or drug abuse within 1 year.
- •Subject with history of severe cardiac, liver or kidney disease or any other medical condition that may interfere with the ability of the subject to participate in the study as determined by the Investigator.
- •Patients already on oral NSAIDs or analgesics.
- •Contraindication or allergy to any substance in the investigational product.
- •Currently, or within the past 30 days, enrolled in a different clinical investigation.
结局指标
主要结局
Evaluation of change in pain score at rest (Visual Analog Scale), change in pain score in motion (Visual Analog Scale), muscle stiffness measured by Numerical Rating Scale (NRS), severity of pain on a 5-point rating scale of very severe, severe, moderate, mild and none, evaluation of severity of stiffness on a 5-point rating scale of very severe, severe, moderate, and mild and none.
时间窗: Baseline (Day 1) and End of study (Day 7)
次要结局
- Tolerability based on a four-point scale (0–3) for erythema, scaling, dryness, pruritus, and burning/stinging.(End of study (Day 7))
- Patient Global Assessment of Treatment Tolerability (PGATT) (overall tolerability)(End of study (Day 7))
- Treatment Emergent Adverse Event(Randomization visit to End of Study)
研究者
Dr Vidyadhar Kumbhar
Sunad Ayurved