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

Primary Purpose

Osteoarthritis, Overweight and Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Epigenorm Antivir
Acupuncture
Sponsored by
Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Laboratory of Clinical ImmunopharmacologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Epigenorm Antivir and acupuncture arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Intermittent and Constant Osteoarthritis Pain self-report questionnaire
Pain measure: Scale range 0-100 with higher scores indicating worse pain
Changes in serum levels of aggrecan
serum levels of aggrecan measured in ng/ml
Changes in serum levels of antibodies to collagen type II
serum levels of antibodies to collagen type II measured AU/ml
Changes in serum levels of C-reactive protein
serum levels of C-reactive protein (CRP), g/l
Changes in histamine levels
serum levels of histamine in ng/ml
Changes in inflammation biomarkers
serum levels of (CRP), interleukin (IL)-6, IL- 18, adiponectin, IL-10, and interferon (IFN) γ in pg/ml
Changes in lipid biomarkers
serum total cholesterol, HDL, and LDL measured in mmol/L
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.

Full Information

First Posted
May 8, 2018
Last Updated
June 29, 2018
Sponsor
Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
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1. Study Identification

Unique Protocol Identification Number
NCT03540186
Brief Title
Epigenorm Antivir Combined With Acupuncture for the Treatment of Osteoarthritis Patients Who Are Overweight or Obese
Official Title
A Nutritional Supplement Epigenome Antivir Combined With Acupuncture for the Treatment of Osteoarthritis Who Are Overweight or Obese
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 29, 2018 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Overweight and Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epigenorm Antivir and acupuncture arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Epigenorm Antivir
Intervention Description
1 capsule of Epigenorm Antivir twice daily for 3 months
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
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
Primary Outcome Measure Information:
Title
Change From Baseline in Visual Analogue Scale for Pain
Description
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
Secondary Outcome Measure Information:
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Pain
Description
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
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL)
Description
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
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Symptoms
Description
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
Title
Quality of life with the The Short Form (36) Health Survey score
Description
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.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
Intermittent and Constant Osteoarthritis Pain self-report questionnaire
Description
Pain measure: Scale range 0-100 with higher scores indicating worse pain
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
Changes in serum levels of aggrecan
Description
serum levels of aggrecan measured in ng/ml
Time Frame
Baseline, 8 weeks
Title
Changes in serum levels of antibodies to collagen type II
Description
serum levels of antibodies to collagen type II measured AU/ml
Time Frame
Baseline, 8 weeks
Title
Changes in serum levels of C-reactive protein
Description
serum levels of C-reactive protein (CRP), g/l
Time Frame
Baseline, 8 weeks
Title
Changes in histamine levels
Description
serum levels of histamine in ng/ml
Time Frame
Baseline, 8 weeks
Title
Changes in inflammation biomarkers
Description
serum levels of (CRP), interleukin (IL)-6, IL- 18, adiponectin, IL-10, and interferon (IFN) γ in pg/ml
Time Frame
Baseline, 8 weeks
Title
Changes in lipid biomarkers
Description
serum total cholesterol, HDL, and LDL measured in mmol/L
Time Frame
Baseline, 8 weeks
Title
Changes in depression scores measured with Patient Health Questionnaire-9 (PHQ9P)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ivan Shirinsky, MD, PhD
Phone
+73832282547
Email
ivan.shirinsky@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Valery Shirinsky, Professor
Phone
+73832282547
Email
valery.shirinsky@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan Shirinsky, MD, PhD
Organizational Affiliation
Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Clinical Immunopharmacology
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Shirinsky, MD, PhD
Phone
+73832282547
Email
ivan.shirinsky@gmail.com
First Name & Middle Initial & Last Name & Degree
Valery Shirinsky, Professor
Phone
+73832282547
Email
valery.shirinsky@gmail.com

12. IPD Sharing Statement

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

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