A randomized placebo controlled trial to evaluate analgesic and anti inflammatory effects for Musculo skeletal disorders.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Change in pain intensity measured through Visual Analogue Scale (VAS) scale from baseline to 15 days.
研究概览
简要总结
Musculo-skeletal pain is one of the major public health issues prevailing globally; they cause long term pain leading to physical disabilities, reducing the ability to work and decreasing the quality of life of the people and becoming a heavy burden in terms of cost to the individual. It encompasses a wide spectrum of disorders from simple ligament injury, sprain to various complicated issues involving the skeletal structure. Lower back pain and osteoarthritis are the most common problems related to Musculo-skeletal disorders. Among the elderly patients, Musculo-skeletal pain is highly prevalent with rates between 40-60%. It is not confined to a single joint, but its multi-site involvement contributes significantly to disability among elderly patients.
In a healthy individual, pain is defined as a complex sensory experience associated with actual or potential tissue damage. Pharmacological treatments include oral and topical analgesics like non-steroidal anti-inflammatory drugs (NSAIDS), paracetamol, tramadol and opioids. While these pain killers can have serious side effects when taken on a longer run, topical agents can achieve a similar efficacy without the involvement of systemic effects. Various herbs and essential oils are mentioned in Ayurvedic treatises and numerous research studies on phytoconstituents have demonstrated analgesic effects of topical application. Based on literature review, an oil blend to relieve pain and stress was developed by Greenspace. The current study intends to assess its efficacy, safety and tolerability in different types of acute and chronic pain conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of both genders with age group between 15-85 years
- •Subjects with Musculo-skeletal pain due to idiopathic, systemic or trauma for more than 24 hours.
- •Pain of VAS scale between 5-44mm (Mild pain) to 45-74 mm (Moderate pain)
- •Subjects who are willing to give written consent.
排除标准
- •1.Subjects suffering from co-morbidities like rheumatoid arthritis, gouty arthritis or psoriatic arthritis.
- •2.Participants with the history of fracture of the joint.
- •3.Subjects under cortico-steroids, NSAIDS or systemic analgesics.
- •4.Subjects with gross disability having difficulty performing their routine chores.
- •5.Hypersensitive to any of the ingredients of the product.
- •7.Any other condition which the investigator feels will jeopardize the trial.
结局指标
主要结局
1.Change in pain intensity measured through Visual Analogue Scale (VAS) scale from baseline to 15 days.
时间窗: Day 0, Day 8 and Day 15
2.Change in functional ability measured through Brief Pain Inventory questionnaire (BPI) from baseline to 15 days.
时间窗: Day 0, Day 8 and Day 15
3.Average time taken for reducing the pain and duration of effectiveness of the oil.
时间窗: Day 0, Day 8 and Day 15
次要结局
- 1. Change in swelling, tenderness or stiffness as per gradation (if present)(2. Change in PEG (Pain, enjoyment, general activity) tool from baseline to 15 days)
研究者
Dr Gangothri S Kumar
Greenspace