This is a multicenter, randomized, double-blind, placebo-controlled, study in subjects with exercise-related knee pain/discomfort to determine the efficacy of a polyherbal capsule compared to placebo capsule in improving exercise capacity and overall parameters of joint health.
Subjects will come to the study site at Visit 1 for screening assessments (which will occur within 14 days before the start of the run-in period) and to answer questions associated with habitual diet, exercise capacity, and level of activity. Those subjects who meet initial inclusion/exclusion criteria will undergo a run-in period of at least 7 days at home to discontinue use of all concurrent dietary supplements. Subjects will then return to the study site at Visit 2 (Baseline; Day 0) for further assessments and those meeting all inclusion/exclusion criteria will be enrolled into the study and randomly assigned to study product. Approximately 108 subjects (54 per treatment group) will be enrolled in the study. Subjects will be evaluated at Visit 3 (Day 14), Visit 4 (Day 45), Visit 5 (Day 60, phone call), and Visit 6 (Day 90). Exercise capacity (ie, 6-minute timed walk distance test) will be assessed, along with overall knee wellness and joint-related symptoms using WOMAC, PGA, Knee Pain Rating Scale, and rescue medication usage. Safety will be assessed by collecting adverse events (AEs) and clinical laboratory data.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
108
Akta Medika Medical Group Research Division
Homestead, Florida, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Radiant Research
Dallas, Texas, United States
Benchmark Research
San Angelo, Texas, United States
6-minute Timed Walk Distance Test
Subjects will walk up and down a hallway for 6 minutes after being instructed to walk as rapidly as possible within their comfort zone and without causing themselves any pain. Study personnel will time each subject with a stopwatch and measure the total distance travelled in the 6 minutes.
Time frame: Visit 6 (Day 90)
6-minute timed walk distance test
Time frame: Visits 3 and 4 (Days 14 and 45, respectively)
WOMAC pain questions
WOMAC Index is a self-administered questionnaire that assesses 3 dimensions of pain, physical function, and joint stiffness in knee and hip osteoarthritis using a battery of 24 questions. The latest version of the instrument (WOMAC 3.1) in 100-mm VAS format will be used in this clinical study.
Time frame: Visits 3, 4, and 6 (Days 14, 45, and 90, respectively)
Patient Global Assessment (PGA)
PGA is a measurement tool to quantify disease activity that asks patients in 100-mm VAS format to rate on a scale how they feel overall.
Time frame: Visits 3, 4, and 6 (Days 14, 45, and 90, respectively)
WOMAC overall score
Time frame: Visits 3, 4, and 6 (Days 14, 45, and 90, respectively).
WOMAC physical function questions
Time frame: Visits 3, 4, and 6 (Days 14, 45, and 90, respectively).
WOMAC joint stiffness questions
Time frame: Visits 3, 4, and 6 (Days 14, 45, and 90, respectively).
Knee Pain Rating Scale
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Radiant Research
San Antonio, Texas, United States
A 100-mm VAS Pain Rating Scale will be used to assess knee discomfort after the 6-minute timed walk distance test, where 0 mm = "No Pain" and 100 mm = "Worst Possible Pain".
Time frame: Visits 3, 4, and 6 (Days 14, 45, and 90, respectively).
Rescue medication usage
Acetaminophen will be permitted as rescue product during the treatment phase and at the end of the 6 minute timed walk distance test. Subjects will be advised to use rescue product only in case of unbearable pain and to restrict the use to a maximum of 4 tablets (2 g) per day.
Time frame: Visits 3, 4, and 6 (Days 14, 45, and 90, respectively).