OsteoarthritisNCT03540186
Epigenorm Antivir Combined With Acupuncture for the Treatment of Osteoarthritis Patients Who Are Overweight or Obese
A study testing Epigenorm Antivir and Acupuncture in people with Osteoarthritis and Overweight and Obesity, run by Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Overweight and Obesity
- What is being tested?
- Epigenorm Antivir and Acupuncture
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteRussia
- Study dates
- 29 Jun 2018to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- osteoarthritis of the knee fulfilling American College of Rheumatology (ACR) criteria
- BMI of 25 or more
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Laboratory of Clinical Immunopharmacology
Novosibirsk, 630047
Ivan Shirinsky, MD, PhD, +73832282547, ivan.shirinsky@gmail.com
Valery Shirinsky, Professor, +73832282547, valery.shirinsky@gmail.com
About this study
Official title: A Nutritional Supplement Epigenome Antivir Combined With Acupuncture for the Treatment of Osteoarthritis Who Are Overweight or Obese
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.
Read the 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.
- Conditions
- Osteoarthritis, Overweight and Obesity
- Being tested
- Epigenorm Antivir, Acupuncture
- Medical subject headings
- Osteoarthritis, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epigenorm AntivirDietary supplement
1 capsule of Epigenorm Antivir twice daily for 3 months
AcupunctureProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Epigenorm Antivir; Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes (12)
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.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Intermittent and Constant Osteoarthritis Pain self-report questionnaire
Pain measure: Scale range 0-100 with higher scores indicating worse pain
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Changes in serum levels of aggrecan
serum levels of aggrecan measured in ng/ml
Measured: Baseline, 8 weeks
Changes in serum levels of antibodies to collagen type II
serum levels of antibodies to collagen type II measured AU/ml
Measured: Baseline, 8 weeks
Changes in serum levels of C-reactive protein
serum levels of C-reactive protein (CRP), g/l
Measured: Baseline, 8 weeks
Changes in histamine levels
serum levels of histamine in ng/ml
Measured: Baseline, 8 weeks
Changes in inflammation biomarkers
serum levels of (CRP), interleukin (IL)-6, IL- 18, adiponectin, IL-10, and interferon (IFN) γ in pg/ml
Measured: Baseline, 8 weeks
Changes in lipid biomarkers
serum total cholesterol, HDL, and LDL measured in mmol/L
Measured: Baseline, 8 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start29 Jun 2018
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Shirinsky, MD, PhD, Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
- Investigators
- Ivan Shirinsky, MD, PhD, Principal investigator, Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540186
- Sponsor's protocol ID
- LCI002
- Status last verified
- Jun 2018
- First submitted
- 8 May 2018
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nutritional Supplement Epigenome Antivir Combined With Acupuncture for the Treatment of Osteoarthritis Who Are Overweight or Obese
- ClinicalTrials.gov ID
- NCT03540186
- Acronym / sponsor ID
- LCI002
- Conditions
- Osteoarthritis, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical ImmunologyUniversity, hospital or other
- Study start
- 29 Jun 2018 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 30 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epigenorm Antivir and acupuncture arm | Experimental | Dietary Supplement: Epigenorm Antivir, Procedure: AcupunctureEpigenorm 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- osteoarthritis of the knee fulfilling American College of Rheumatology (ACR) criteria
- BMI of 25 or more
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epigenorm Antivir1 capsule of Epigenorm Antivir twice daily for 3 months | Dietary supplement | Epigenorm Antivir and acupuncture arm |
| AcupunctureAcupuncture 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 | Procedure or surgery | Epigenorm Antivir and acupuncture arm |
Primary outcome
Change From Baseline in Visual Analogue Scale for Pain
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
The Visual Analogue Scale for Pain varies from 0 to 10 cm. Higher values represent worse outcomes.
12 secondary outcomes
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Pain
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL)
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Symptoms
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Quality of life with the The Short Form (36) Health Survey score
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Intermittent and Constant Osteoarthritis Pain self-report questionnaire
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Changes in serum levels of aggrecan
Time frame: Baseline, 8 weeks
Changes in serum levels of antibodies to collagen type II
Time frame: Baseline, 8 weeks
Changes in serum levels of C-reactive protein
Time frame: Baseline, 8 weeks
Changes in histamine levels
Time frame: Baseline, 8 weeks
Changes in inflammation biomarkers
Time frame: Baseline, 8 weeks
Changes in lipid biomarkers
Time frame: Baseline, 8 weeks
Changes in depression scores measured with Patient Health Questionnaire-9 (PHQ9P)
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivan Shirinsky, MD, PhD principal investigator
Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epigenorm Antivir and Acupuncture in people with Osteoarthritis and Overweight and Obesity, run by Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ivan Shirinsky, MD, PhD (+73832282547, ivan.shirinsky@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Visual Analogue Scale for Pain (time frame: Baseline, 4 weeks, 8 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.