A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of Collavant n2 in individuals with osteoarthritis of the knee.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
236
2 capsules in the morning before breakfast and 2 capsules at night before going to bed for 180 days
2 capsules in the morning before breakfast and 2 capsules at night before going to bed for 180 days
2 capsules in the morning before breakfast and 2 capsules at night before going to bed for 180 days
Amber Clinic
Ahmedabad, Gujarat, India
Prme Orthopedic Speciality
Mumbai, Maharashtra, India
Diamond Hospital
Mumbai, Maharashtra, India
Ayush Nursing Home
Mumbai, Maharashtra, India
Western Ontario and McMaster Universities Osteoarthritis Index Pain subscale
Knee joint pain as assessed by the change in the Western Ontario and McMaster Universities Osteoarthritis Index Pain subscale (WOMAC-P) score. the primary efficacy variable for the present study is the total WOMAC index score, the scores for each subscale will be summed up (Pain range: 0-20, Stiffness range: 0-8, and Physical function range: 0-68). Thus, the total WOMAC score will range from 0 - 96. The lowest the score is the good response and highest the score is extreme pain i.e. bad response.
Time frame: Day 0, 7, 30, 60, 90, 120, 150, and 180
Knee joint pain as assessed by the change in the Western Ontario and McMaster - Pain subscale score.
The first domain, WOMAC-P, comprises 5 questions evaluating the amount of pain due to OA in the index joint experienced by the participant. The WOMAC-P subscale score of 0 indicates 'No pain' and 4 indicates 'Extreme pain'.
Time frame: Day 0, 7, 30, 60, 90, 120, 150, and 180
Knee joint stiffness as assessed by the change in the WOMAC - Stiffness subscale (WOMAC-S) score.
The domain, WOMAC-S, consists of 2 questions evaluating the amount of stiffness (resistance of the joint to movement characterized by difficulty in moving the joint along with pain and discomfort in the joint) experienced in the index joint. On the Likert scale, 0 indicates 'No stiffness' and 4 indicates 'Extreme stiffness'.
Time frame: Day 0, 7, 30, 60, 90, 120, 150, and 180
Knee joint function as assessed by the change in the WOMAC - Physical function (WOMAC-PF) score.
The WOMAC-PF consists of 17 questions evaluating the degree of physical difficulty experienced in the index joint due to OA in the third domain. For WOMAC-PF, 0 indicates 'No difficulty' and 4 indicates 'Extreme difficulty'.
Time frame: Day 0, 7, 30, 60, 90, 120, 150, and 180
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Life Care Hospital
Nashik, Maharashtra, India
Sparsh Hospital
Panvel, Maharashtra, India
Care n Cure Multispeciality Hospital
Pālghar, Maharashtra, India
Lifepoint Multispeciality Hospital
Pune, Maharashtra, India
Imperial Multispecialty Hospital
Pune, Maharashtra, India
Gayatri Hospital
Vasai, Maharashtra, India
Knee joint pain assessed by the change in the Visual Analogue Scale (VAS) score.
Point 0 indicates no pain and 10 indicates worst pain.
Time frame: Day 0, 7, 30, 60, 90, 120, 150, and 180
Severity of osteoarthritis as assessed by the change in the Lequesne algofunctional index (LAI) score.
Higher scores indicate a worse joint condition and Lowest scores indicate agood joint condition
Time frame: Day 0, 7, 30, 60, 90, 120, 150, and 180