Osteoarthritis, KneeNCT03442153
Comparative Efficacy and Tolerability of No7 in Osteoarthritis of the Knee
A study testing Solgar No7 Complex in people with Osteoarthritis, Knee, run by Ambrosia - SupHerb Ltd..
Trial 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 more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Solgar No7 Complex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 14Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Solgar No7 Complex, placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solgar No7 ComplexDietary supplement
Solgar No7 Capsules
placeboDietary supplement
Also called Placebo for Solgar No7
Placebo tablets Cellulose
| Study group | Role | What they receive |
|---|---|---|
| Solgar No7 | Experimental | Aflapin 100 mg and Collagen UC2 40 mg by mouth every 24 hours for 90 days Receives: Dietary Supplement: Solgar No7 Complex |
| Placebo for Solgar No7 | Placebo comparator | Placebo 1 Capsule by mouth, every 24 hours for 90 days Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Self reported pain intensity in the scale 1-10
Measured: 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 (3)
Knee Stiffness
The stiffness of the knee according to the doctor evaluation
Measured: 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
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study startMar 2018 (estimated)
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ambrosia - SupHerb Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guy Rubin, Principal investigator, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442153
- Sponsor's protocol ID
- Ambrosia
- Status last verified
- Feb 2018
- First submitted
- 9 Jan 2018
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy and Tolerability of No7 in Osteoarthritis of the Knee: A Double Blind, Randomized, Placebo Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT03442153
- Acronym / sponsor ID
- Ambrosia
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Ambrosia - SupHerb Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2018 (estimated)
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Solgar No7 | Experimental | Dietary Supplement: Solgar No7 ComplexAflapin 100 mg and Collagen UC2 40 mg by mouth every 24 hours for 90 days |
| Placebo for Solgar No7 | Placebo comparator | Dietary Supplement: placeboPlacebo 1 Capsule by mouth, every 24 hours for 90 days |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solgar No7 ComplexSolgar No7 Capsules | Dietary supplement | Solgar No7 |
| placeboAlso: Placebo for Solgar No7Placebo tablets Cellulose | Dietary supplement | Placebo for Solgar No7 |
Primary outcome
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
3 secondary outcomes
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
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Rubin principal investigator
HaEmek Medical Center, Israel
Questions about this trial
What is this clinical trial studying?
A study testing Solgar No7 Complex in people with Osteoarthritis, Knee, run by Ambrosia - SupHerb Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evgeny Vaysberg, Pharmacist (+972506670597, evgenyiw@solgar.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.