The study evaluates analgesic, antiinflammatory and metabolic effects of a supplement Epigenome-Antivir (extracts of glycyrrhiza roots, hippophae rhamnoides leaves, curcumin, green tea, and vitamin C) combined with acupuncture in patients with knee osteoarthritis (OA) and metabolic syndrome.
Epigenome-Antivir components have long been used in traditional medicine and have been shown to exert anti-inflammatory properties both in vitro and in vivo. It has also been shown that acupuncture can provide a moderate analgesic effect in osteoarthritis. It is anticipated that the combination of Epigenome-Antivir and acupuncture will reduce pain, inflammatory and metabolic markers in patients with OA and metabolic syndrome.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
1 capsule of Epigenorm Antivir twice daily for 3 months
Acupuncture involves inserting sterile needles into the skin. The needles do not go into the skin very far. Number of acupuncture sessions: no less than 15 sessions, based on the physician discretion
Laboratory of Clinical Immunopharmacology
Novosibirsk, Russia
RECRUITINGChange From Baseline in Visual Analogue Scale for Pain
The Visual Analogue Scale for Pain varies from 0 to 10 cm. Higher values represent worse outcomes.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Pain
KOOS Pain consists of 9 items, which are answered on a 4-point likert scale (0=no problems, 4=extreme problems). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL)
KOOS ADL consists of 17 items, which are answered on a 4-point likert scale (0=no problems, 4=extreme problems). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Symptoms
KOOS Symptoms consists of 7 items, which are answered on a 4-point likert scale (0=no problems, 4=extreme problems). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Quality of life with the The Short Form (36) Health Survey score
he Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
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Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Intermittent and Constant Osteoarthritis Pain self-report questionnaire
Pain measure: Scale range 0-100 with higher scores indicating worse pain
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Changes in serum levels of aggrecan
serum levels of aggrecan measured in ng/ml
Time frame: Baseline, 8 weeks
Changes in serum levels of antibodies to collagen type II
serum levels of antibodies to collagen type II measured AU/ml
Time frame: Baseline, 8 weeks
Changes in serum levels of C-reactive protein
serum levels of C-reactive protein (CRP), g/l
Time frame: Baseline, 8 weeks
Changes in histamine levels
serum levels of histamine in ng/ml
Time frame: Baseline, 8 weeks
Changes in inflammation biomarkers
serum levels of (CRP), interleukin (IL)-6, IL- 18, adiponectin, IL-10, and interferon (IFN) γ in pg/ml
Time frame: Baseline, 8 weeks
Changes in lipid biomarkers
serum total cholesterol, HDL, and LDL measured in mmol/L
Time frame: Baseline, 8 weeks
Changes in depression scores measured with Patient Health Questionnaire-9 (PHQ9P)
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. It consists of nine questions with responses ranging from "0" (not at all) to "3" (nearly every day). The possible range is 0-27. Higher values represent worse outcome.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks