Osteoarthritis, Overweight and Obesity
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTEpigenorm Antivir
1 capsule of Epigenorm Antivir twice daily for 3 months
PROCEDUREAcupuncture
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
Sponsors
Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* osteoarthritis of the knee fulfilling American College of Rheumatology (ACR) criteria * BMI of 25 or more
Exclusion criteria
* use of NSAIDs one month prior to study entry (paracetamol is allowed) * pregnancy and lactation * increased sensitivity to the study drug * clinically significant renal function impairment * use of antidepressants * diagnosis of bipolar disorder * use of symptomatic slow acting drugs of OA (SYSADOA) one month prior to study entry * any condition which may lead to difficulties to participation in the study from the viewpoint of Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Visual Analogue Scale for Pain | Baseline, 4 weeks, 8 weeks, 12 weeks | The Visual Analogue Scale for Pain varies from 0 to 10 cm. Higher values represent worse outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL) | Baseline, 4 weeks, 8 weeks, 12 weeks | 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. |
| Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Symptoms | Baseline, 4 weeks, 8 weeks, 12 weeks | 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. |
| Quality of life with the The Short Form (36) Health Survey score | Baseline, 4 weeks, 8 weeks, 12 weeks | 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. |
| Intermittent and Constant Osteoarthritis Pain self-report questionnaire | Baseline, 4 weeks, 8 weeks, 12 weeks | Pain measure: Scale range 0-100 with higher scores indicating worse pain |
| Changes in serum levels of aggrecan | Baseline, 8 weeks | serum levels of aggrecan measured in ng/ml |
| Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Pain | Baseline, 4 weeks, 8 weeks, 12 weeks | 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. |
| Changes in serum levels of C-reactive protein | Baseline, 8 weeks | serum levels of C-reactive protein (CRP), g/l |
| Changes in histamine levels | Baseline, 8 weeks | serum levels of histamine in ng/ml |
| Changes in inflammation biomarkers | Baseline, 8 weeks | serum levels of (CRP), interleukin (IL)-6, IL- 18, adiponectin, IL-10, and interferon (IFN) γ in pg/ml |
| Changes in lipid biomarkers | Baseline, 8 weeks | serum total cholesterol, HDL, and LDL measured in mmol/L |
| Changes in depression scores measured with Patient Health Questionnaire-9 (PHQ9P) | Baseline, 4 weeks, 8 weeks, 12 weeks | 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. |
| Changes in serum levels of antibodies to collagen type II | Baseline, 8 weeks | serum levels of antibodies to collagen type II measured AU/ml |
Countries
Russia
Contacts
Primary ContactIvan Shirinsky, MD, PhD
Backup ContactValery Shirinsky, Professor
Outcome results
None listed