Comparative Clinical Study to Assess the Efficacy and Tolerability of Kwik Pain Oil and Tila Oil in Musculoskeletal Pain
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in Visual Analogue Scale (VAS) for Pain, Pain relief period, Duration of pain free period
研究概览
简要总结
Musculoskeletal pain, encompassing discomfort in the muscles, bones, ligaments, tendons, and nerves, is a prevalent health issue that affects individuals of all ages. It can be acute, arising from injuries or overuse, or chronic, resulting from underlying conditions such as arthritis or fibromyalgia. The pain may manifest as stiffness, inflammation, or tenderness, often limiting mobility and affecting overall quality of life. In Ayurveda, the primary cause of musculoskeletal disorders is the aggravation of Vata Dosha. Contributing factors, known as Nidana Sevana, include the consumption of Vata-aggravating foods, excessive physical exertion, intake of unwholesome food, and a sedentary lifestyle. When Vata Dosha becomes aggravated, it obstructs the body’s empty channels, leading to the development of musculoskeletal disorders, which can affect either a specific part of the body or the entire system. Kwik Pain Oil will be prepared and provided by Ozone Pharmaceutical Ltd. Test Drug Composition: Each 100 ml contains: Ingredients Gandhpura Taila (Gaultheria fragrantissima) Lf. Oil 15 g, Mahanarayan Taila 5 g, Vishagarbha Taila 5 g, Brihatmash Taila 5 g, Pudina Ka Phool (Mentha spicata) Crystal 5 g, Atasi Taila (Linum usitatissimum) Seed Oil 3 g, Tailaparnah Taila (Eucalyptus globulus) Lf. Oil 2 g, Kapoor (Cinnamomum camphora) Plant Ext. Powder 1 g, Capsaicin Resin (Capsicum minimum) Fruit 0.002 g, Ajwain Taila (Trachyspermum ammi) Seed Oil 0.75 g, Base q.s. Objectives - Primary Objective – 1. To assess the efficacy of local application of ‘Kwik Pain Oil’ for its effect on musculoskeletal pain. 2. To compare the efficacy of ‘Kwik Pain Oil’ and tila taila in the management of musculoskeletal pain. Secondary Objective – 3. To assess the safety and tolerability of local application of ‘Kwik Pain Oil’.
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
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients willing to sign the consent form of the clinical trial.
- •Outdoor patients, having chronic pain of musculoskeletal origin (e.g., low backache, knee, shoulder, elbow, wrist, ankle, and neck pain for more than 4 weeks).
排除标准
- •History of any trauma/fractured joint/surgical/diagnostic intervention with reference to the affected joint(s), Gross disability in performing daily normal routine, i.e., bed-ridden patients or confined to a wheelchair Patients with co-morbidities such as gouty arthritis, rheumatoid arthritis, and psoriatic arthritis, Patients having any deformity of knee hip or back altering their gait and posture Concomitant use of pain-relieving medications, Patients on prolonged (more than 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc., or any other drugs that may have an influence on the outcome of the study, Allergy to ‘Kwik Pain Oil’ or Tila Taila.
结局指标
主要结局
Changes in Visual Analogue Scale (VAS) for Pain, Pain relief period, Duration of pain free period
时间窗: At baseline, 1st week and 2nd week
次要结局
- Patient satisfaction & Adverse effects.(At 1st & 2nd week)
研究者
Dr Sumit Nathani
National Institute of Ayurveda, Deemed to be University (De Novo))
