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

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

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis; Overweight and Obesity
• Intervention / Treatment: Dietary supplement: Epigenorm Antivir; Procedure: Acupuncture

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ivan Shirinsky, MD, PhD; Phone Number: +73832282547; Email: ivan.shirinsky@gmail.com
• Study Contact Backup: Name: Valery Shirinsky, Professor; Phone Number: +73832282547; Email: valery.shirinsky@gmail.com

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630047
    • Recruiting
    • Laboratory of Clinical Immunopharmacology
    • Contact: Ivan Shirinsky, MD, PhD; Phone Number: +73832282547; Email: ivan.shirinsky@gmail.com
    • Contact: Valery Shirinsky, Professor; Phone Number: +73832282547; Email: valery.shirinsky@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epigenorm Antivir and acupuncture arm; 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; 1 capsule of Epigenorm Antivir twice daily for 3 months; Procedure: Acupuncture; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
• Investigators: Principal Investigator: Ivan Shirinsky, MD, PhD, Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2018
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: June 29, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Overweight
• Other Study ID Numbers: LCI002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No