Health Condition 1: M15-M19- Osteoarthritis
Conditions
Interventions
None listed
Sponsors
Pillcraft Private Limited, India.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults (male and female) aged between 50 and 75 years. 2. Participants must have a confirmed diagnosis of osteoarthritis, as determined by clinical evaluation and relevant imaging studies. 3. Participants with osteoarthritis affecting major weight-bearing joints, such as the hip, spine, and knee. 4. Participants on stable doses of analgesic or anti-inflammatory medications for at least two weeks prior to the study. 5. No plan to commence new treatments over the study period. 6. Participants should be willing to adhere to the study protocol, including the use of topical Cannabis and Boswellia oil. 7. Participants must provide informed consent after being thoroughly informed about the study objectives, procedures.
Exclusion criteria
Exclusion criteria: 1. Known allergies or hypersensitivity to cannabis, Boswellia, or any components of the topical formulations. 2. Participants with severe osteoarthritis or joint deformities that may require surgical intervention during the study period. 3. Participants with chronic pain conditions unrelated to osteoarthritis, such as rheumatoid arthritis, fibromyalgia, or neuropathic pain. 4. Recent changes in medication related to osteoarthritis treatment within the last two weeks. 5. Participants with active skin infections or dermatological conditions in the areas where the topical treatments will be applied. 6. History of substance abuse or dependence within the past year. 7. Patients who had participated in other clinical trials during the previous 3 months. 8. Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol. 9. Uncontrolled medical conditions, such as uncontrolled hypertension or diabetes, that may interfere with study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in pain scores assessed on a 0-10 Visual Analog Scale (VAS) from baseline.Timepoint: Baseline, Week 2, Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in scores for Short Form (SF-12) quality of life questionnaire from baseline.Timepoint: Baseline, Week 2, Week 4;Number and proportion of patients who required rescue. medications.Timepoint: Week 2, Week 4;Number and proportion of rescue medications given to patients.Timepoint: Week 2, Week 4;Patient Global Assessment (PGA) for efficacy and tolerability at end of treatment.Timepoint: Week 4;Mean change in scores for WOMAC-24 scale from baseline.Timepoint: Baseline, Week 2, Week 4 | — |
Countries
India
Contacts
Public ContactMr Yash Kochar
KEM Hospital
Outcome results
None listed