MedPath

Comparing the Effects of Cannaquic Oil and Diclofenac Oil on Osteoarthritis: A clinical Study

Phase 2
Conditions
Health Condition 1: M15-M19- Osteoarthritis
Registration Number
CTRI/2024/08/072537
Lead Sponsor
Hempcann solutions Pvt Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. To assess the Efficacy of Cannaquic oil in the management of osteoarthritis. <br/ ><br>2. Rapid recovery from symptoms. <br/ ><br>3. The change in visual analog scale, and WOMAC score <br/ ><br>Timepoint: 1. To assess the Efficacy parameters after 30 days of treatment. <br/ ><br>2. To evaluate the change in visual analog scale, and WOMAC score after 30 days <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
1. To find out, the incidence of adverse events during the study period. <br/ ><br>2. To evaluate treatment Adherence/Compliance <br/ ><br>Timepoint: 1. To evaluate the incidence of adverse events after 30 days. <br/ ><br>2. To evaluate the treatment adherence after 30 days.
© Copyright 2025. All Rights Reserved by MedPath