Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: LS/PO/01: Apply a sufficient amount of oil on both knees with a gentle massage twice a day for 60 days.
Intervention2: LS/PO/02: Apply a sufficient amount of oil on both knees with a ge
Sponsors
Life Synergy
Eligibility
Inclusion criteria
Inclusion criteria: Participants meeting all the following criteria will be eligible for the study: 1. Adults aged 45 to 65 years (both inclusive), of both sexes, with a Body Mass Index (BMI) not more than 30.00 kg per meter square; 2. Clinical diagnosis of osteoarthritis of the knee based on clinical evaluation and or radiographic evidence; 3. Participants with a pain visual analog scale (VAS) score between 1-7 (mild-moderate) preceding recruitment; 4. Participant ambulant and requiring treatment with an anti inflammatory drug and not receiving regular anti inflammatory or analgesic drugs or not satisfied with drugs being taken and seek a change; 5. Participants willing to come for regular follow up visits and provide data of the analgesic consumption during study period; 6. Participants can walk and give both verbal and written information regarding the study.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will not be eligible for the study: 1. Participants incapacitated or bound to wheelchair or bed and unable to carry out self-care activities; 2. Treatment with intra-articular injection of corticosteroids into the knee within 3 months preceding study; 3. Ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate, and colchicine; 4. Administration of intra-articular steroids in the past 3 months or hyaluronic acid in the last 9 months; 5. Indication of surgery for OA knee; 6. Arthroscopy of either knee in the past year; 7. Any condition that in the opinion of the investigator does not justify the participant’s inclusion for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. WOMAC A, B, and C subscale scores for pain, stiffness and physical disability. WOMAC-A is assessed by a Likert scale on a range from 0 (none) to 4 (extreme), with higher scores indicating higher levels of pain, WOMAC- B for levels of stiffness and WOMAC-C for levels of physical disability 2. VAS pain scale score 3. Knee range of motion (ROM) measured by goniometer 4. Symptom grading on a 4-point Linkert scale for joint swelling, tenderness, and warmthTimepoint: 1. Baseline, day 15, 30, day 60 2. Screening, baseline, day 15, 30, day 60 3. Screening and day 60 4. Baseline, day 15, 30, day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events profile 2. Tolerability of the investigational product Timepoint: From baseline to day 60. | — |
Countries
India
Contacts
Public ContactDr Vaishnavi Patil
Life Synergy
Outcome results
None listed