Evaluation of Efficacy and Safety of Topical Oil Formulation (206B) Containing Cannabis Sativa and Boswellia Serrata in Patients with Osteoarthritis of Hip, Spine, and Knee: A Prospective, Randomized, Double-blind, Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean change in pain scores assessed on a 0-10 Visual Analog
研究概览
简要总结
In this study, a total of 100 patients will be enrolled. At the initial visit, prospective patients would be screened for enrollment based on the requirements of the study, history, and clinical examination. Before starting any study-related procedures, patients would be explained about the study in detail and written informed consent would be obtained to participate in this study. A detailed medical history including the associated conditions will be recorded. A general and physical examination would be done to see any abnormal parameters. After satisfying the eligibility criteria, patients will be enrolled in the study. After enrollment in the study, Subjects will be asked to apply 206B topical oil containing Boswellia serrata gum-resin extract (50%), Cannabis sativa leaf extract (3%), and MCT Oil (47%) and identical placebo oil containing MCT (100%) thrice daily for 4 weeks. All the subjects will be asked to continue their routine diet and physical activities during the whole study period. All subjects will be followed up during the study period (visit 1 (screening visit/ enrolment visit/ baseline visit- day 1), visit 2 (week 2) ± 4 days, visit 3 (week 4) ± 4 days.The Adverse events, either spontaneously reported by the patient, or noticed by the clinician will be recorded during the study.
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
- 50.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults (male and female) aged between 50 and 75 years.
- •Participants must have a confirmed diagnosis of osteoarthritis, as determined by clinical evaluation and relevant imaging studies.
- •Participants with osteoarthritis affecting major weight-bearing joints, such as the hip, spine, and knee.
- •Participants on stable doses of analgesic or anti-inflammatory medications for at least two weeks prior to the study.
- •No plan to commence new treatments over the study period.
- •Participants should be willing to adhere to the study protocol, including the use of topical Cannabis and Boswellia oil.
- •Participants must provide informed consent after being thoroughly informed about the study objectives, procedures.
排除标准
- •Known allergies or hypersensitivity to cannabis, Boswellia, or any components of the topical formulations.
- •Participants with severe osteoarthritis or joint deformities that may require surgical intervention during the study period.
- •Participants with chronic pain conditions unrelated to osteoarthritis, such as rheumatoid arthritis, fibromyalgia, or neuropathic pain.
- •Recent changes in medication related to osteoarthritis treatment within the last two weeks.
- •Participants with active skin infections or dermatological conditions in the areas where the topical treatments will be applied.
- •History of substance abuse or dependence within the past year.
- •Patients who had participated in other clinical trials during the previous 3 months.
- •Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol.
- •Uncontrolled medical conditions, such as uncontrolled hypertension or diabetes, that may interfere with study participation.
结局指标
主要结局
Mean change in pain scores assessed on a 0-10 Visual Analog
时间窗: Baseline, Week 2, Week 4
Scale (VAS) from baseline.
时间窗: Baseline, Week 2, Week 4
次要结局
- Mean change in scores for WOMAC-24 scale from baseline.(Baseline, Week 2, Week 4)
- Mean change in scores for Short Form (SF-12) quality of life(questionnaire from baseline.)
- Number and proportion of patients who required rescue.(medications.)
- Number and proportion of rescue medications given to patients.(Week 2, Week 4)
- Patient Global Assessment (PGA) for efficacy and tolerability at(end of treatment.)
研究者
Dr Mohan Desai
KEM Hospital