Comparative Efficacy and Tolerability of No7 in Osteoarthritis of the Knee

NCT03442153 | Unknown

• 1 other identifier: Ambrosia
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the effect of dietary supplement Solgar No7 in 76 adult Osteoarthritis of the Knee Patients, while the other half will receive placebo.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

  Self reported pain intensity in the scale 1-10

  Pain intensity Reported to the Doctor after one month of the treatment. Each item is scored 0-10 (0=no pain; 10=pain as bad as can be), yielding a total between 0 and 30.

Secondary Outcomes (3)

• Knee Stiffness

  nee Stiffness checked by the Doctor after one month of treatment. Each item is scored 0-10 (0=no pain; 10=pain as bad as can be), yielding a total between 0 and 30

• Non Steroidal Anti Inflammatory Drugs Usage

  Pain Medication Usage as Reported to the Doctor after one month of treatment. Each item is scored as a number of the dose units that were used during the all period (0=no medications, 1=only one dose of medication etc)

• Adverse Reactions

  Adverse Reactions as Reported to the Doctor over the period of the treatment. Each item is scored as a number of the dose units that were used during the all period (0=no adverse reactions, 1=only one adverse reaction etc)

Study Arms (2)

Solgar No7

EXPERIMENTAL

Aflapin 100 mg and Collagen UC2 40 mg by mouth every 24 hours for 90 days

Dietary Supplement: Solgar No7 Complex

Placebo for Solgar No7

PLACEBO COMPARATOR

Placebo 1 Capsule by mouth, every 24 hours for 90 days

Dietary Supplement: placebo

Interventions

Solgar No7 Complex DIETARY_SUPPLEMENT

Solgar No7 Capsules

Solgar No7

placebo DIETARY_SUPPLEMENT

Placebo tablets Cellulose

Also known as: Placebo for Solgar No7

Placebo for Solgar No7

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Osteoarthritis (at least 2-nd grade according to Kellgren Classification)
• Ability to walk independently
• Pain Intensity of 4 or more according to Visual Analogue Scale
• NSAIDs usage of 5 times or more per month during 3 months before the intervention
• Ability to understand the benefits and risks of the proposed treatment and can provide answers to the required questions and fill out a questionnaire in Hebrew
• Early consent of participants not to start a new treatment for Osteoarthritis including medication, surgery, physiotherapy, laser therapy, etc. during the period of the study (3 months) - except for a clear medical need (should report to the investigators immediately)

You may not qualify if:

• Inflammatory Arthropathy, Severe Rheumatoid Arthritis, Psoriatic Arthritis or Gout
• History of injection of pharmacological material (steroids, anesthetic, hyaluronic acid or any other pharmacological substance) into the knee joint during the six months prior to the start of the study
• Taking of biological drugs that may affect inflammatory conditions (such as anti-TNF- alpha, etc.) or oral PO steroids - even if given to another disease, for more than 5 days during 3 months prior to the start of the study
• Chronic administration of any anti-inflammatory drug during the study period and / or at least one month prior to commencement of the study.
• Chronic administration of medical cannabis
• Use of analgetics in a formulation that provides a half-life of over 24 hours (eg, Butrans, Fentanyl)
• Chronic use of vitamin K antagonists, Heparin, Enoxaparin
• Injury to the knee during six months prior to the experiment
• Expectations of surgical intervention, physiotherapy or other treatment of osteoarthritis before the end of the study period
• Significant irregularities in renal or liver function, active malignant disease in the last 3 years, heart failure, uncontrolled hypertension, active peptic ulcer, hematologic diseases, severe neurological diseases, and mental illness with seizures in the last two years.
• Peripheral neuropathy that treated by any drug
• High alcohol consumption (over 2 standard doses per day)
• Sensitivity to one of the ingredients and / or sensitivity to NSAIDs. It is Possible to include a patient who is sensitive to a specific drug from the family of NSAIDs, but can take other drugs from this family.
• Any medical condition or treatment which, in the opinion of the investigators, may mask the results of the study and / or interfere with the research questions and / or terminate the research properly and / or endanger the participant in any way during the course of the study.

Sponsors & Collaborators

• Ambrosia - SupHerb Ltd.: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Guy Rubin

  HaEmek Medical Center, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evgeny Vaysberg, Pharmacist

CONTACT

+972506670597; evgenyiw@solgar.co.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The product in not drug or medical device (but a dietary supplement). There are 76 participants divided inti 2 groups : experimental group (38) and Placebo group (38). The period of the intervention: 90 days

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: February 22, 2018
• Study Start: March 1, 2018
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: February 22, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share