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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solgar No7 | Experimental | Aflapin 100 mg and Collagen UC2 40 mg by mouth every 24 hours for 90 days |
|
| Placebo for Solgar No7 | Placebo Comparator | Placebo 1 Capsule by mouth, every 24 hours for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solgar No7 Complex | Dietary Supplement | Solgar No7 Capsules |
| |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evgeny Vaysberg, Pharmacist | Contact | +972506670597 | evgenyiw@solgar.co.il |
| Name | Affiliation | Role |
|---|---|---|
| Guy Rubin | HaEmek Medical Center, Israel | Principal Investigator |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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
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| placebo |
| Dietary Supplement |
Placebo tablets Cellulose |
|
|
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) |
| D012216 |
| Rheumatic Diseases |