Clinical trial NCT03540186: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Overweight and Obesity
Lead sponsor: Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline in Visual Analogue Scale for Pain
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Pain
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Symptoms
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Quality of life with the The Short Form (36) Health Survey score
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Intermittent and Constant Osteoarthritis Pain self-report questionnaire
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Changes in serum levels of aggrecan
timeFrame: Baseline, 8 weeks
measure: Changes in serum levels of antibodies to collagen type II
timeFrame: Baseline, 8 weeks
measure: Changes in serum levels of C-reactive protein
timeFrame: Baseline, 8 weeks
measure: Changes in histamine levels
timeFrame: Baseline, 8 weeks
measure: Changes in inflammation biomarkers
timeFrame: Baseline, 8 weeks
measure: Changes in lipid biomarkers
timeFrame: Baseline, 8 weeks
measure: Changes in depression scores measured with Patient Health Questionnaire-9 (PHQ9P)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Laboratory of Clinical Immunopharmacology
Study officials:
affiliation: Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
name: Ivan Shirinsky, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: