A SINGLE-ARM, OPEN-LABEL INTERVENTIONAL STUDY TO EVALUATE THE ANTI-INFLAMMATORY EFFECT OF A CANNABIS BASED FORMULATION WSR TO OSTEOARTHRITIS.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Evaluation of Anti-Inflammatory Effect in Osteo-Arthritis Patients treated with Cannabis based Polyherbal formulation
研究概览
简要总结
Inflammation is a fundamental pathological process underlying several acute and chronic clinical conditions, including pain syndromes, musculoskeletal disorders, gynaecological conditions, metabolic disorders, and sleep disturbances. Persistent low-grade inflammation is often reflected by elevated inflammatory biomarkers such as C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and pro-inflammatory cytokines.
Cannabis and certain herbal constituents possess documented anti-inflammatory, analgesic, and immunomodulatory properties, mediated through modulation of the endocannabinoid system, cyclooxygenase pathways, and cytokine signalling. Polyherbal formulations incorporating cannabis are traditionally used in integrative medicine systems for inflammatory conditions; however, systematic clinical evidence supporting their anti-inflammatory effects remains limited.
This study is designed as a single-arm, open-label, exploratory clinical trial to generate preliminary evidence on the anti-inflammatory potential, clinical response, and safety profile of a cannabis-based formulation using objective inflammatory markers and clinical assessments on patients with Osteo Arthritis. The present study will enable us to observe the efficacy of a Cannabis based polyherbal formulation in joint pain management on those patients who are suffering from Osteoarthritis.
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
- 50.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female subjects who are suffering from Osteo Arthritis.
- •Subjects willing to give a written informed consent and agree to come for a regular follow-up visit.
- •Subjects willing to abide by and comply with the study protocol.
- •Subjects who have not participated in a similar investigation in the past three months.
- •Subjects who have not taken any analgesics or NSAIDs, etc for a period of 15 days before the start of the trial and are willing to avoid them till the end of the trial.
排除标准
- •Subjects who have undergone invasive treatments like surgery within 3 months before screening into the study.
- •Subjects having any active disease that may interfere with the study.
- •Any history of underlying uncontrolled medical illness, including diabetes mellitus, hypertension, HIV, hepatitis, severe anaemia, serious disorder of the heart and respiratory apparatus or any other serious medical illness.
- •A known history or present condition of allergic response/hypersensitivity to any ingredients and pharmaceutical products.
- •Subjects who had been part of any other clinical study within 3 months before screening into the study.
结局指标
主要结局
Evaluation of Anti-Inflammatory Effect in Osteo-Arthritis Patients treated with Cannabis based Polyherbal formulation
时间窗: Baseline, 30 Days (After Treatment) and 90 Days (After follow-up)
次要结局
- Evaluation of Pain Reduction.(Baseline, Day 7, Day 15, Day 21, Day 30 (After Treatment), Day 60 & Day 90 (After Follow-up))
- Evaluation of Quality of Life(Baseline, Day 7, Day 15, Day 21, Day 30 (After Treatment), Day 60 & Day 90 (After Follow-up))
- Evaluation of ESR & CRP(Baseline & Day 30.)
研究者
Dr Ravishankar A G
Prasanna College of Ayurveda and Hospital