Epiitalis is an ingredient of a currently marketed product named as Osteo-Restore, indicated for joint health.The present study is primarily planned to establish the role of Epiitalis as a single ingredient in the treatment of mild to moderate cases of knee Osteoarthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
237
Kurla Nursing Home
Mumbai, Maharashtra, India
Sai Baba Hospital
Mumbai, Maharashtra, India
Diamond Hospital
Mumbai, Maharashtra, India
Ayush Nursing Home
Mumbai, Maharashtra, India
Effect of consumption of IP on knee joint pain as assessed by the change in the 100-point Visual Analogue Scale (VAS) from baseline and when compared with the placebo.
Participant's assessment of pain will be done on a 100 mm Visual Analogue Scale (Pain), where 0 means no pain and 100 means unbearable pain.
Time frame: From baseline to 56 days
Quality of life as assessed by a SF-36 questionnaire
The 36 Item Short Form Health Survey (SF36) Questionnaire is a set of generic, coherent, and easily administered quality of life measures. These measures rely upon participant self reporting.
Time frame: From baseline to 56 days
Effect of IP consumption and the placebo on Knee joint pain, Knee joint stiffness & Knee joint function as assessed by a specific questionnaire
WOMAC is a widely used questionnaire for Osteoarthritis. WOMAC Index is a tri dimensional self administered questionnaire to assess joint pain, stiffness \& physical function. WOMAC Pain comprises of 5 questions related to knee joint pain that score fro 0 to 4 (0 means no pain \& 4 means extreme pain). WOMAC Stiffness consists of 2 items (score 0-4, 0 means no stiffness and 4 means extreme stiffness). WOMAC Physical function consists of 17 items with scores 0 to 4 with same scoring pattern.
Time frame: From baseline to 56 days
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