Health Condition 1: M255- Pain in joint
Conditions
Interventions
None listed
Sponsors
Sahyadri Ayurvedic Life Pvt Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Participants will be eligible to participate if they meet all of the following criteria: 1. Adults of either gender, aged 18 to 80 years at the time of enrollment. 2. Participants diagnosed with inflammatory joint conditions, including but not limited to: Back pain Knee pain Osteoarthritis Other musculoskeletal joint disorders associated with pain and stiffness. 3. Participants with history of joint pain, swelling, stiffness, knee pain, frozen shoulder and lower back pain for at least 3 months prior to screening. 4. Participants who are willing to avoid other pain relief medications or therapies for joint pain, unless approved by the investigator. 5. Participants who are willing and able to provide written informed consent. 6. Participants who are willing to comply with the study requirements, including completing all scheduled visits and questionnaires.
Exclusion criteria
Exclusion criteria: Participants will be excluded if they meet any of the following criteria: 1. Known severe rheumatoid arthritis or autoimmune inflammatory joint diseases requiring systemic immunosuppressive therapy. 2. Recent joint injury, fracture, or joint surgery within the past 3 months. 3. Severe joint deformity or advanced joint destruction that may interfere with evaluation of treatment response. 4. Severe neurological disorders or musculoskeletal disorders affecting mobility. 5. Active skin infection, wounds, or dermatological conditions at the site where liniment oil or Swedana therapy will be applied. 6. Known hypersensitivity or allergy to any ingredient of the investigational products. 7. Uncontrolled systemic diseases, including uncontrolled diabetes mellitus, severe cardiovascular disease, or severe hepatic or renal impairment. 8. Pregnant or lactating women. 9. Current use of systemic corticosteroids, strong analgesics, or other investigational therapies for joint disorders within 30 days prior to screening. 10. Participation in another clinical trial within 3 months prior to screening. 11. History of drug or alcohol abuse or dependence within the past 5 years. 12. Any clinically significant medical or psychiatric condition that, in the Investigator s opinion, may interfere with study participation or interpretation of results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is: 1.Change in Joint Pain and Functional Status: - Change in Joint Pain and Function Questionnaire (JPFQ) total score from Baseline (Day 0) to End of Treatment (Day 60 2 days). - Assessment will be conducted at Baseline (Day 0), Day 30 ( 2 days) and End of Treatment (Day 60 ( 2 days)). - A clinically meaningful improvement will be defined as: - greater than or equal to 30 percentage reduction in total Joint Pain and Function Questionnaire score from baseline, OR - A statistically significant reduction in mean symptom score from Baseline (Day 0) to Day 60 ( 2 days). Timepoint: Day 0 - Visit 1 Day 30 2 days - Visit 2 Day 60 2 days - Visit 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Quality of Life: a. Change in SF-36 Quality of Life Questionnaire total score from Baseline (Day 0) to End of Treatment (Day 60 ( 2 days)). b. Assessment will be conducted at Baseline (Day 0), Day 30 ( 2 days) & End of Treatment (Day 60 ( 2 days)). c. A clinically meaningful improvement will be defined as: d. Greater than or equal to 5 10 point increase in the SF-36 total score or key domains (physical functioning & bodily pain) from baseline to Day 60 ( 2 days). Timepoint: Day 0 - Visit 1 Day 30 2 days - Visit 2 Day 60 2 days - Visit 3;2. Change in Clinical Symptom Severity: a. Change in clinical symptom severity scores (joint pain, joint stiffness, joint swelling, & joint mobility) from Baseline (Day 0) to Day 30( 2 days) & Day 60 ( 2 days). b. Symptoms will be assessed using a 4-point symptom severity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). c. A clinically meaningful improvement will be defined as: d. Greater than or equal to 1-point reduction in symptom severity score in at least two clinical symptoms, OR e. Greater than or equal to 30 percentage reduction in the total combined symptom severity score from baseline to Day 60 ( 2 days) Timepoint: Day 0 - Visit 1 Day 30 2 days - Visit 2 Day 60 2 days - Visit 3;3.Safety & Tolerability a. Incidence, type, severity, & causality of Adverse Events (AEs) reported throughout the study period. b. Any Serious Adverse Events (SAEs) reported during the study. c. Changes in vital signs (including systolic blood pressure, diastolic blood pressure, pulse rate, & respiratory rate) from Baseline to Day 30 ( 2 days) & Day 60 ( 2 days). d. Findings from physical examination at each study visit. e.Investigator s overall safety & tolerability assessment during the study period.Timepoint: Day 0 - Visit 1 Day 30 2 days - Visit 2 Day 60 2 days - Visit 3 | — |
Countries
India
Contacts
Public ContactMs Mamatha B Gokavi
Sahyadri Ayurvedic Life Pvt Ltd.
Outcome results
None listed