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

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

Status: Unknown

Conditions: Osteoarthritis; Overweight and Obesity

Treatments: Procedure: Acupuncture; Dietary Supplement: Epigenorm Antivir

Study type: Interventional

Funder types: Other

Identifiers

NCT03540186

LCI002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Epigenorm Antivir and acupuncture arm

Experimental group

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.

Treatment:

Procedure: Acupuncture

Dietary Supplement: Epigenorm Antivir