Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Gogo Pain Relief & MSM: The test product Gogo Pain Relief & MSM (M) is a blend of extracts/oil from Gaultheria Procumbens (Wintergreen), Lavandula Angustifolia, Aniba Rosaeodora, Anthem
Sponsors
Gods Own Store LLP
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants must be adults, aged at least 35 to 80 yrs old with radiographically established OA. 2. At screening, subjects must complete questionnaires that would provide investigators with information on their medical and OA history and demographics. Pain level in the last week will be evaluated using the Visual Analog Scale (VAS) and functionality in activities of daily living with the Western Ontario and McMaster Universities Osteoarthritis Index. 3. Females Subjects must have a negative pregnancy test. Pregnant patients or individual with history of pregnancy will be excluded from the study. 4. Subjects should be having a pre-randomization score of 40 to 90 on the Western Ontario and McMaster Universities Osteoarthritis Index. 5. Participants should be willing to sign a written consent for participation in the study and undergo a baseline interview. 6. Participants must be willing to apply the test product and return for assessment visits for evaluation. 7. Participants must agree that during the study they will refrain from taking any new herbal supplement and prescription or non-prescription medications that has not been recommended by the study physician.
Exclusion criteria
Exclusion criteria: 1. Participants with rheumatoid arthritis; fibromyalgia; recurrent or active pseudogout, cancer, or other serious medical conditions 2. Single or married subjects who are pregnant or have borne children in past one year. 3. Participants with a history of signs or history of kidney or liver failure OR asthma requiring use of corticosteroids OR use of oral corticosteroids within the past 4 weeks 4. Participants with a history of intra-articular knee depo corticosteroids within the previous 3 months, or intra-articular hyaluronate within the previous 6 months. 5. Participants with evidence or history of medical or surgical event in the past year that may significantly affect the study outcome such as arthroscopy of the knee within the previous year; significant injury to the knee within the previous 6 months; or a rash or open wound over the knee. 6 Patients reporting use of prescription or non-prescription drugs that has not been pre-approved by the study physician. 7. Participant with known allergies to the main components of the test product or placebo. 8. Participation in another clinical trial or taking an investigational product in the past three months 9. Any participant who is not able to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Criteria for efficacy are: 1. A negative change in WOMAC scores from baseline indicating improvement of symptoms and limitations; as compared to the placebo (WOMAC assesses pain, stiffness and physical functional disability using a series of 24 questions). 2. Negative change in the VAS score assessing pain 3. Range of motion in degrees. X-ray will be done both at baseline and at the end of the treatment to evaluate the benefit of the treatment. Timepoint: Day 0 Day 30 Day 60 Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints comprise of the safety analyses i.e Adverse events including SAEs.Timepoint: Day 0 Day 30 Day 60 Day 90 | — |
Countries
India
Contacts
Public ContactDr Jitendra Singh Kushwaha
Prakhar Hospital Pvt. Ltd.
Outcome results
None listed