Comparative Efficacy and Tolerability of No7 in Osteoarthritis of the Knee

NCT ID: NCT03442153

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-31
• Study Completion Date: 2018-05-31

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.

Detailed Description

Solgar No7 is a Dietary Supplement marketed in Israel on a regular basis with the approval of the Israeli Ministry of Health. The product is based on Herbal Extracts and Vitamins. The individual components of the product were effective in some studies in relieving pain and inflammation in such patients. This Study evaluates the effect of these components as a complex.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Solgar No7

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

Group Type: EXPERIMENTAL

Solgar No7 Complex

Intervention Type: DIETARY_SUPPLEMENT

Solgar No7 Capsules

Placebo for Solgar No7

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo tablets Cellulose

Interventions

Solgar No7 Complex

Solgar No7 Capsules

Intervention Type: DIETARY_SUPPLEMENT

placebo

Placebo tablets Cellulose

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Placebo for Solgar No7

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ambrosia - SupHerb Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guy Rubin

Role: PRINCIPAL_INVESTIGATOR

HaEmek Medical Center, Israel

Central Contacts

Evgeny Vaysberg, Pharmacist

Role: CONTACT

evgenyiw@solgar.co.il

+972506670597

Other Identifiers

Ambrosia

Identifier Type: -

Identifier Source: org_study_id