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Comparative Efficacy and Tolerability of No7 in Osteoarthritis of the Knee

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ClinicalTrials.gov Identifier: NCT03442153
Recruitment Status : Not yet recruiting
First Posted : February 22, 2018
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Ambrosia - SupHerb Ltd.

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Dietary Supplement: Solgar No7 Complex Dietary Supplement: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Comparative Efficacy and Tolerability of No7 in Osteoarthritis of the Knee: A Double Blind, Randomized, Placebo Controlled Clinical Study
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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 Name: Placebo for Solgar No7




Primary Outcome Measures :
  1. Pain Intensity [ Time Frame: 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. ]
    Self reported pain intensity in the scale 1-10


Secondary Outcome Measures :
  1. Knee Stiffness [ Time Frame: 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 ]
    The stiffness of the knee according to the doctor evaluation

  2. Non Steroidal Anti Inflammatory Drugs Usage [ Time Frame: 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) ]
    Self reported Non Steroidal Anti Inflammatory Drugs Usage

  3. Adverse Reactions [ Time Frame: 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) ]
    Self reported Adverse Reactions



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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442153


Contacts
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Contact: Evgeny Vaysberg, Pharmacist +972506670597 evgenyiw@solgar.co.il

Sponsors and Collaborators
Ambrosia - SupHerb Ltd.
Investigators
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Principal Investigator: Guy Rubin HaEmek Medical Center, Israel

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Responsible Party: Ambrosia - SupHerb Ltd.
ClinicalTrials.gov Identifier: NCT03442153     History of Changes
Other Study ID Numbers: Ambrosia
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases