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 - NI

Hempcann solutions Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•1. 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.
•2. Subjects experiencing Musculo skeletal system with pain as major symptoms.
•3. 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.
•4. Subjects suffering from chronic pain with a baseline pain intensity of 6 or above on a 10-cm visual analog scale (VAS).
•5. Patients receiving any other local medication for symptomatic management of pain can be included after a wash out period of 7 days.
•6. Willing to give written informed consent.

•1. Subjects with abnormal hematologic function (Hemoglobin 8gm/dl, WBC count 3000/mm3, platelet count 100,000/mm3).
•2. 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.
•3. History of any deformities or any wound in the affected area.
•4. Any concomitant serious disorders like hepatic dysfunction, chronic kidney disease, cardiovascular diseases, pulmonary disease, and use of chemotherapy agents or history of cancer.
•5. 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.
•6. Gravid women and lactating mother.
•7. Heavy smoker, Chronic alcoholic, or drug abuse subjects
•8. Known cases of malignancy, HIV infection, AIDS, etc.
•9. 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.
•10. Participants are not willing to sign the ICF and to attend the treatment schedule regularly.

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