NCT03540186

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

June 29, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

4 months

First QC Date

May 8, 2018

Last Update Submit

June 29, 2018

Conditions

OsteoarthritisOverweight and Obesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Pain

    Baseline, 4 weeks, 8 weeks, 12 weeks

  • Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL)

    Baseline, 4 weeks, 8 weeks, 12 weeks

  • Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Symptoms

    Baseline, 4 weeks, 8 weeks, 12 weeks

  • Quality of life with the The Short Form (36) Health Survey score

    Baseline, 4 weeks, 8 weeks, 12 weeks

  • Intermittent and Constant Osteoarthritis Pain self-report questionnaire

    Baseline, 4 weeks, 8 weeks, 12 weeks

  • +7 more secondary outcomes

Study Arms (1)

Epigenorm Antivir and acupuncture arm

EXPERIMENTAL

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 AntivirProcedure: Acupuncture

Interventions

Epigenorm AntivirDIETARY_SUPPLEMENT

1 capsule of Epigenorm Antivir twice daily for 3 months

Epigenorm Antivir and acupuncture arm
AcupuncturePROCEDURE

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

Epigenorm Antivir and acupuncture arm

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • osteoarthritis of the knee fulfilling American College of Rheumatology (ACR) criteria
  • BMI of 25 or more

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Clinical Immunopharmacology

Novosibirsk, 630047, Russia

RECRUITING

MeSH Terms

Conditions

OsteoarthritisOverweightObesity

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Ivan Shirinsky, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivan Shirinsky, MD, PhD

CONTACT

+73832282547ivan.shirinsky@gmail.com

Valery Shirinsky, Professor

CONTACT

+73832282547valery.shirinsky@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 8, 2018

First Posted

May 30, 2018

Study Start

June 29, 2018

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

July 2, 2018

Record last verified: 2018-06

Locations

RU(1)