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

NCT ID: NCT03540186

Last Updated: 2018-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-29

Study Completion Date

2018-11-30

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.

Conditions

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Osteoarthritis Overweight and Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Epigenorm Antivir

Intervention Type DIETARY_SUPPLEMENT

1 capsule of Epigenorm Antivir twice daily for 3 months

Acupuncture

Intervention Type PROCEDURE

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

Interventions

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Epigenorm Antivir

1 capsule of Epigenorm Antivir twice daily for 3 months

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type PROCEDURE

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology

OTHER

Sponsor Role lead

Responsible Party

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Ivan Shirinsky, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ivan Shirinsky, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology

Locations

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Laboratory of Clinical Immunopharmacology

Novosibirsk, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Ivan Shirinsky, MD, PhD

Role: CONTACT

+73832282547

Valery Shirinsky, Professor

Role: CONTACT

+73832282547

Facility Contacts

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Ivan Shirinsky, MD, PhD

Role: primary

+73832282547

Valery Shirinsky, Professor

Role: backup

+73832282547

Other Identifiers

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LCI002

Identifier Type: -

Identifier Source: org_study_id

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