A Randomized Open-Label Interventional Clinical Study to Evaluate the Safety and Efficacy of Global Cannabidiol Formulation on Osteoarthritis Patients with Joint Pain and Inflammation.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in joint pain and inflammation severity (efficacy of CBD) using WOMAC or equivalent scale. Comparative improvement in pain, stiffness, and function between CBD and placebo groups
研究概览
简要总结
This clinical study is a randomized, open-label, interventional trial designed to evaluate the safety and efficacy of a global CBD oral nanoformulation in patients with moderate to severe osteoarthritis (OA). Osteoarthritis is a degenerative joint disease characterized by joint pain, stiffness, and reduced mobility, often due to mechanical wear and tear. Current treatments such as NSAIDs and opioids offer symptomatic relief but are often associated with significant adverse effects. In this context, cannabidiol (CBD), known for its anti-inflammatory and analgesic properties, is being explored as a safer alternative. The study enrolls 60 adult participants aged 18–65 years who experience chronic joint pain with a baseline intensity of 6 or more on the Visual Analog Scale (VAS). Participants are randomly assigned into two groups: one receiving 5 ml of the CBD nanoformulation twice daily, and the other receiving a placebo, both for a duration of 90 days.
The primary objective is to assess the efficacy of the CBD nanoformulation in reducing OA symptoms and to compare its performance against a placebo. Symptom changes are measured using validated tools such as the VAS and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), focusing on pain, stiffness, and physical function from baseline to Day 90. Secondary objectives include evaluating the safety and tolerability of the formulation through adverse event reporting and laboratory assessments. Follow-up visits are scheduled on Day 30, Day 60, and Day 90, with clinical, biochemical, and compliance evaluations conducted at each stage.
This study adheres to Good Clinical Practice (GCP) guidelines and the Declaration of Helsinki, ensuring ethical conduct and participant safety. The findings of this trial aim to provide robust clinical evidence on the role of CBD nanoformulations as a non-opioid, plant-based therapeutic option in managing osteoarthritis, potentially improving patients’ quality of life with a favorable safety profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female with age of 18-65 years.
- •Subjects diagnosed with moderate to severe osteoarthritis with symptoms of pain and swelling, tenderness, morning stiffness, of one or more joint continuously for more than 3 weeks.
- •Subjects suffering from chronic pain with a baseline pain intensity of 6 or above on a 10-cm visual analog scale (VAS).
- •Patients receiving any other local medication for symptomatic management of pain can be included after a wash out period of 7 days.
- •Willing to give written informed consent.
排除标准
- •Subjects with abnormal hematologic function (Hemoglobin 8gm/dl, WBC count 3000/mm3, platelet count 100,000/mm3).
- •Subjects with present known or signs of serious spinal pathology (i.e., cauda equine syndrome, trauma, fractures, or cancer); history of abdominal, lumbar, or lower limb surgery in the past year; rheumatologic disease in the acute inflammatory phase.
- •History of any deformities or any wound in the affected area.
- •Any concomitant serious disorders like hepatic dysfunction, chronic kidney disease, cardiovascular diseases, pulmonary disease, and use of chemotherapy agents or history of cancer.
- •A history of psychiatric disorders that may interfere with study participation or affect the ability to comply with the protocol requirements.
- •Gravid women and lactating mother.
- •Heavy smoker, Chronic alcoholic, or drug abuse subjects Known cases of malignancy, HIV infection, AIDS, etc.
- •Subject who participated in any other clinical investigation using an experimental drug or has donated blood .
- •Participants are not willing to sign the ICF and to attend the treatment schedule regularly.
结局指标
主要结局
Change in joint pain and inflammation severity (efficacy of CBD) using WOMAC or equivalent scale. Comparative improvement in pain, stiffness, and function between CBD and placebo groups
时间窗: To assess the reduction in joint pain and inflammation severity using the WOMAC score and Visual analogue scale from Day 1 (baseline) to Day 90 (End of study). | To compare the improvement in pain, stiffness, and function between interventional and placebo groups from Day 1 (baseline) to Day 90 (End of study).
次要结局
- The study aims to evaluate the safety and tolerability of CBD through the assessment of adverse events and laboratory parameters. In addition, it will assess the efficacy of CBD on osteoarthritis symptoms by observing changes in the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score, which measures pain, stiffness, and physical function.(Assessments will be conducted at baseline (Week 0) before starting treatment and at the endpoint (Week 12). Optional interim evaluations for safety and laboratory monitoring will also be performed at Weeks 4 and 8.)
研究者
Dr RC Satish Kumar
Interdisciplinary Institute of Indian System of Medicine