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| ID | Type | Description | Link |
|---|---|---|---|
| 224 | Registry Identifier | registration study |
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| Name | Class |
|---|---|
| Valeant Russia, LLC | UNKNOWN |
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The purpose of the study is to assess the efficacy and safety of Neuromultivit (solution for injections) in treatment of vertebrogenic radiculopathy L5, S1 in comparison with standard therapy. The patients are randomised into two groups: standard therapy group and standard therapy plus Neuromultivit group.
Group 1 (50 patients) receive Neuromultivit (2 ml per day, i.m.) for 7 days, then -Neuromultivit (2 ml per day, i.m.) every other day for 10 days and standard therapy for 20 days.
Group 2 (50 patients) receive only standard therapy for 20 days.
Standard therapy involves:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuromultivit +Voltaren+Sirdalud | Experimental | Neuromultivit 2ml i.m. once a day for 7 days, then 2 ml i.m. one time every other day for 10 days. Voltaren 100mg per os once a day for 20 days. Sirdalud 2 mg per os three times a day for 20 days. |
|
| Voltaren+Sirdalud alone | Active Comparator | Voltaren 100mg per os once a day for 20 days Sirdalud 2 mg per os three times a day for 20 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromultivit | Drug |
| ||
| Voltaren |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Pain Intensity at Rest and with Activity in Visual Analoguе Scale | Self reported pain intensity over the last 24 hours. The amount of pain is marked on a horizontal line at a certain point which reflects pain perception best: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). | baseline and 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Pain Quality and Intensity in McGill Pain Questionnaire | Self reported quality and intensity of pain, described by selecting 7 words, which reflect pain perception best, from 20 groups: three words from groups 1-10, two words from groups 11-15, a single word from group 16, one word from groups 17-20. | baseline and 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Systolic Blood Pressure at 10 Days | baseline and 10 days | |
| Change from Baseline in Systolic Blood Pressure at 3 weeks | baseline and 3 weeks | |
| Change from Baseline in Heart Rate and Rhythm (Electrocardiogram) at 3 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Farit Khabirov, MD, DSc, Prof | State Autonomous Institution Republican Clinical Centre of Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Autonomous Institution Republican Clinical Centre of Neurology | Kazan' | Tatarstan Republic | 420021 | Russia |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| C023754 | tizanidine |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Sirdalud | Drug |
|
| Change from Baseline in Low Back Pain Intensity in Aberdeen Back Pain Scale | Self reported effect of pain on body functions and daily activities. The scores of responses to 19 questions (6 multiple choice questions and 13 single choice questions) are summed, yielding a total between 0 and 100 with higher values representing greater disability. | baseline and 3 weeks |
| Change from Baseline in Low Back Pain Intensity in Quebec Back Pain Disability Scale | Self reported pain related functional limitations to 20 activities. The degree of difficulty in performing these daily activities is scored from 0-5 (0 = no effort, 5 = not able to), yielding a total between 0 and 100 with higher values representing greater disability. | baseline and 3 weeks |
| baseline and 3 weeks |
| Change from Baseline in Full Blood Count at 3 weeks | baseline and 3 weeks |
| Change from Baseline in Urine Test at 3 weeks | baseline and 3 weeks |