Clinical trial NCT03442153: Comparative Efficacy and Tolerability of No7 in Osteoarthritis of the Knee
Official title: Comparative Efficacy and Tolerability of No7 in Osteoarthritis of the Knee: A Double Blind, Randomized, Placebo Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Ambrosia - SupHerb Ltd.
Sponsor class: INDUSTRY
First posted: 2018-02-22
Enrollment: 76
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Pain Intensity
timeFrame: 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:
measure: Knee Stiffness
timeFrame: 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
measure: Non Steroidal Anti Inflammatory Drugs Usage
timeFrame: 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)
measure: Adverse Reactions
timeFrame: 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)
Other outcomes:
Locations:
Study officials:
affiliation: HaEmek Medical Center, Israel
name: Guy Rubin
role: PRINCIPAL_INVESTIGATOR
References: