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Status unknownNCT03442153Updated Feb 22, 2018

Comparative Efficacy and Tolerability of No7 in Osteoarthritis of the Knee

An interventional study of Solgar No7 Complex and placebo in Osteoarthritis, Knee, sponsored by Ambrosia - SupHerb Ltd.. Status unknown. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-02-22.

Sponsored by Ambrosia - SupHerb Ltd. · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
45 Years to 75 Years
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Osteoarthritis, Knee
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Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
76 participants (estimated)

Study arms

  • Experimental
    Solgar No7

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

    Dietary Supplement: Solgar No7 Complex

  • Placebo comparator
    Placebo for Solgar No7

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

    Dietary Supplement: placebo

Interventions

  • Dietary supplementSolgar No7 Complex

    Solgar No7 Capsules

  • Dietary supplementplacebo

    Placebo tablets Cellulose

    Also known as: Placebo for Solgar No7

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What researchers measure

Primary outcomes

  1. Pain Intensity

    Self reported pain intensity in the scale 1-10

    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.

Secondary outcomes

  1. Knee Stiffness

    The stiffness of the knee according to the doctor evaluation

    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

  2. Non Steroidal Anti Inflammatory Drugs Usage

    Self reported 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)

  3. Adverse Reactions

    Self reported 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)

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03442153
Lead sponsor
Ambrosia - SupHerb Ltd.
Responsible party
Sponsor
First posted
Feb 22, 2018
Start date
Mar 2018 (estimated)
Primary completion
May 2018 (estimated)
Completion
May 2018 (estimated)
Last update
Feb 22, 2018

Study contacts

Evgeny Vaysberg, Pharmacist
Contact
evgenyiw@solgar.co.il
+972506670597
Guy Rubin
principal investigator · HaEmek Medical Center, Israel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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