An Open label, Prospective, Single-arm, Multicentric Clinical Study to Evaluate the Safety and Efficacy of Rumalaya Liniment Roll-On in Musculoskeletal conditions.
概览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Efficacy Endpoints
概览
简要总结
This is an open-label, prospective, single-arm, multicentric clinical study designed to evaluate the safety and efficacy of Rumalaya Liniment Roll-On in individuals suffering from various musculoskeletal conditions. The study aims to assess the effectiveness of the product in providing relief from pain, stiffness, and discomfort associated with conditions such as cervical spondylosis, lumbar spondylosis, sciatica, carpal tunnel syndrome, tennis elbow, chronic joint pain, joint immobility, chronic muscle pain, sprains, and strains. Participants will receive Rumalaya Liniment Roll-On as per the recommended application guidelines, and outcomes will be assessed using validated pain and functional scoring tools over a defined treatment period. The study will also monitor adverse events to evaluate the safety profile of the product. The findings will help support the clinical utility of Rumalaya Liniment Roll-On in the management of common musculoskeletal disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
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 male and female participants aged between18-65 years.
- •Participants presenting with mild to moderate pain (Pain score 1-6 based on VAS (Appendix I)) due to known musculoskeletal conditions like Cervical and lumbar spondylosis, sciatica, carpal tunnel syndrome, tennis elbow, chronic joint pain, joint immobility, chronic muscle pain, Sprains, Strains, etc.
- •Note: If participants have pain in multiple locations, only one location will be considered for the assessment by the investigator.
- •Participants who have not participated in any other similar clinical study in the last one month.
- •Participants willing to sign informed consent and follow the study procedure.
- •Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, throughout the duration of study participation.
- •Note: A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: a)Has not undergone a hysterectomy or bilateral oophorectomy; or b)Has not attained menopause (Women not menstruating for at least 12 consecutive months).
排除标准
- •Participants with severe musculoskeletal conditions (bruises, trauma, muscle damage, raw wounds, fractures, hematoma etc.).
- •Participants who are on any regular pain killers or have used any oral or topical pain killers (NSAIDs, opioid analgesics, steroid medication, muscle relaxant, herbal etc.) in the past 24 hours prior to screening.
- •Participants who are not willing to refrain from using any other similar topical applications during the study period.
- •Any known generalized skin conditions, condition that prevents easy application of the test product (disorders, presence of open wounds etc.).
- •Participants with known clinically significant neurological, respiratory, cardiovascular, gastrointestinal, hepatic, congenital or any other chronic disorder that can interfere with the study conduct in the opinion of the Investigator.
- •Participants with known history or present condition of allergic response to any of the ingredients in the investigational product.
- •Pregnant as assessed by UPT & History of Amenorrhea and lactating women.
- •Known history of drug abuse/dependency that would limit ability to comprehend or follow instructions related to informed consent, treatment instructions, study procedures or follow-up guidelines.
- •Any other conditions (physical, psychological, social or uncontrolled dietary measures) that can interfere with the participant’s compliance to the study in the opinion of the Investigator.
结局指标
主要结局
Efficacy Endpoints
时间窗: Day 1, Day 5 and Day 14.
•Time required for the onset of pain relief
时间窗: Day 1, Day 5 and Day 14.
•Time required for next/successive application (lasting pain relief)
时间窗: Day 1, Day 5 and Day 14.
•Reduction in pain, swelling, tenderness, redness, muscle stiffness and immobility based on Visual Analogue Scale (VAS).
时间窗: Day 1, Day 5 and Day 14.
•Product feedback questionnaire
时间窗: Day 1, Day 5 and Day 14.
次要结局
- Safety Endpoints(1. General Physical and Vital Signs.)
研究者
Dr Bharat Raj R
Mithra-Multi Speciality Hospital