Comparative Efficacy and Tolerability of No7 in Osteoarthritis of the Knee

Comparative Efficacy and Tolerability of No7 in Osteoarthritis of the Knee: A Double Blind, Randomized, Placebo Controlled Clinical Study

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Dietary supplement: Solgar No7 Complex; Dietary supplement: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Evgeny Vaysberg, Pharmacist; Phone Number: +972506670597; Email: evgenyiw@solgar.co.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Solgar No7; Aflapin 100 mg and Collagen UC2 40 mg by mouth every 24 hours for 90 days	Dietary supplement: Solgar No7 Complex; Solgar No7 Capsules
Placebo Comparator: Placebo for Solgar No7; Placebo 1 Capsule by mouth, every 24 hours for 90 days	Dietary supplement: placebo; Placebo tablets Cellulose; Other Names: Placebo for Solgar No7

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Stiffness	The stiffness of the knee according to the doctor evaluation	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	Self reported 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	Self reported 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)

Collaborators and Investigators

• Sponsor: Ambrosia - SupHerb Ltd.
• Investigators: Principal Investigator: Guy Rubin, HaEmek Medical Center, Israel

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2018
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): February 22, 2018
• Last Update Submitted That Met QC Criteria: February 20, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Ambrosia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No