Safety and Efficacy of Neuromultivit in Treatment of Vertebrogenic Radiculopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-11-30

Brief Summary

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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.

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Detailed Description

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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:

* Voltaren (100 mg prolonged-released film-coated tablets once daily) for 20 days
* Sirdalud (2 mg tablets three times a day) for 20 days

Conditions

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Vertebrogenic Radiculopathy L5, S1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neuromultivit +Voltaren+Sirdalud

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.

Group Type EXPERIMENTAL

Neuromultivit

Intervention Type DRUG

Voltaren

Intervention Type DRUG

Sirdalud

Intervention Type DRUG

Voltaren+Sirdalud alone

Voltaren 100mg per os once a day for 20 days Sirdalud 2 mg per os three times a day for 20 days

Group Type ACTIVE_COMPARATOR

Voltaren

Intervention Type DRUG

Sirdalud

Intervention Type DRUG

Interventions

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Neuromultivit

Intervention Type DRUG

Voltaren

Intervention Type DRUG

Sirdalud

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* diagnosed vertebrogenic radiculopathy L5, S1
* radicular pain syndrome
* changes in the low back CT and MRI scans
* minimum 40 mm intensity of spontaneous back pain, rated on the VA scale
* 1 month exacerbation phase; nonuse of any B-group vitamins before the trial
* negative urine pregnancy test; Patient Informed Consent

Exclusion Criteria

* tumors, inflammatory infections, any neurological diseases, imitating the symptoms of radiculopathy
* concomitant life-threatening medical conditions
* simultaneous administration of acetylsalicylic acid, levodopa, prednisolone; any psychiatric diseases
* epilepsy, alcohol and drug addiction
* pregnancy and breast-feeding
* any condition preventing CT and MRI tests, including obesity and special devices
* participation in any other clinical study 1 month before enrollment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No