Evaluation of Safety and Efficacy of Cannaquic oil in comparison with Diclofenac oil for the management of Osteoarthritis – A Double-blind, Randomized controlled clinical study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1. To assess the Efficacy of Cannaquic oil in the management of osteoarthritis.
研究概览
简要总结
Evaluation of Safety and Efficacy of Cannaquic Oil in Comparison with Diclofenac Oil for theManagement of Osteoarthritis – A Double-Blind Randomized Controlled Clinical Study
Study Overview:
1. This study aims to explore a novel treatment approach for osteoarthritis (OA), a prevalent degenerative joint disease characterized by the deterioration of cartilage leading to pain, stiffness, and reduced joint function. Sponsored by Hempcann Solutions Pvt Ltd., this study investigates the efficacy and safety of cannaquic oil, an Ayurvedic formulation with pain-relieving properties derived from 14 vata-balancing herbs, in comparison to diclofenac oil, a commonly used NSAID.
Design and Methodology:
Study Design: Double-blind, randomized controlled trial
Number of Participants: 80
Groups: One group receiving cannaquic oil and the other receiving diclofenac oil
Duration: 30 days
Application: Twice daily
Primary Objectives:
1. 1. Assess the efficacy of cannaquic oil in managing osteoarthritis.
2. 2.Compare the safety and efficacy of cannaquic oil with diclofenac oil.
Secondary Objectives:
1. 1. Evaluate the safety and tolerability of cannaquic oil through adverse event monitoring and laboratory parameters.
2. 2. Measure changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score from baseline to the study’s conclusion.
Inclusion Criteria:
1. 1.Males and females aged 18-65.
2. 2.Diagnosed with moderate to severe osteoarthritis, confirmed by clinical evaluation and radiographic findings.
3. 3.Experiencing significant pain.
Exclusion Criteria:
1. 1.Severe comorbid conditions.
2. 2.Psychiatric disorders.
3. 3.Substance abuse issues.
4. 4.Recent participation in other clinical studies.
Assessment and Evaluation:
1. Baseline and End-of-Study Assessments: Changes in pain levels, physical function, and adverse events.
2. Efficacy Evaluation: Clinical evaluations, visual analog scales, and WOMAC scores.
3. Safety Monitoring: Hematological and biochemical parameters.
Objective:
Provide a comprehensive evaluation of cannaquic oil as a potential alternative treatment for osteoarthritis, emphasizing a holistic Ayurvedic approach that could mitigate the side effects associated with conventional allopathic treatments like NSAIDs. The findings aim to contribute to the growing body of research on complementary and alternative medicine, offering new insights into managing osteoarthritis and improving the quality of life for affected individuals.
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
- •Subjects with moderate to severe Arthritis with symptoms of pain and swelling, tenderness, morning stiffness, of one or more joint continuously for more than 3 weeks.
- •Subjects experiencing Musculo skeletal system with pain as major symptoms.
- •Subjects with confirmed diagnosis of osteoarthritis based on clinical evaluation and radiographic findings consistent with OA in one or more joints (e.g., knee, hip, hand) according to established criteria such as the American College of Rheumatology (ACR) criteria.
- •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.
- •Evidence of psychiatric disorder (schizophrenia, suicidal tendency), Seizure, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with 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 or had more than 300ml of blood drawn in the past 3 months.
- •Participants are not willing to sign the ICF and to attend the treatment schedule regularly.
结局指标
主要结局
1. To assess the Efficacy of Cannaquic oil in the management of osteoarthritis.
时间窗: 1. To assess the Efficacy parameters after 30 days of treatment. | 2. To evaluate the change in visual analog scale, and WOMAC score after 30 days
2. Rapid recovery from symptoms.
时间窗: 1. To assess the Efficacy parameters after 30 days of treatment. | 2. To evaluate the change in visual analog scale, and WOMAC score after 30 days
3. The change in visual analog scale, and WOMAC score
时间窗: 1. To assess the Efficacy parameters after 30 days of treatment. | 2. To evaluate the change in visual analog scale, and WOMAC score after 30 days
次要结局
- 1. To find out, the incidence of adverse events during the study period.(2. To evaluate treatment Adherence/Compliance)
研究者
R C Satish Kumar
SRM Institute Science and Technology