Epigenorm Antivir Combined With Acupuncture for the Treatment of Osteoarthritis Patients Who Are Overweight or Obese

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Nutritional Supplement Epigenome Antivir Combined With Acupuncture for the Treatment of Osteoarthritis Who Are Overweight or Obese

Conditions
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Osteoarthritis, Overweight and Obesity

Intervention / Treatment
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* Dietary Supplement: Epigenorm Antivir
* Procedure: Acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epigenorm Antivir and acupuncture arm<br>Epigenorm Antivir is a dietary supplement containing extracts of glycyrrhiza roots, hippophae rhamnoides leaves, curcumin, green tea, and vitamin C. Acupuncture involves inserting needles at certain points of the body. | Dietary Supplement: Epigenorm Antivir<br>* 1 capsule of Epigenorm Antivir twice daily for 3 months<br>Procedure: Acupuncture<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change 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. | Baseline, 4 weeks, 8 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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 | Baseline, 4 weeks, 8 weeks, 12 weeks | 
| Changes in serum levels of aggrecan | serum levels of aggrecan measured in ng/ml | Baseline, 8 weeks | 
| Changes in serum levels of antibodies to collagen type II | serum levels of antibodies to collagen type II measured AU/ml | Baseline, 8 weeks | 
| Changes in serum levels of C-reactive protein | serum levels of C-reactive protein (CRP), g/l | Baseline, 8 weeks | 
| Changes in histamine levels | serum levels of histamine in ng/ml | 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 | Baseline, 8 weeks | 
| Changes in lipid biomarkers | serum total cholesterol, HDL, and LDL measured in mmol/L | 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. | Baseline, 4 weeks, 8 weeks, 12 weeks |