The purpose of this multicentre randomized double-blind placebo controlled phase III trial is to determine the therapeutic effect of Neurotec, a novel herbal drug made by ParsRoos Companyin Iran, in symptomatic diabetic neuropathy. 300 patients with past history of at least 1 year symptomatic diabetic neuropathy will be assigned to one of the following treatment groups through a permuted block randomization method. Group 1 will receive 120 mg (1 capsule) Neurotec two times a day, group 2 will receive Gabapentin 300 mg (1 capsule) two times a day and group 3 will receive placebo (1 identical capsules as active drugs three times a day) for 4 months and 1 capsule a day for another two-month period. Patients will be followed for three months after completion of treatment period. Follow-up visits will be done every other week by a general physician and every month by a Physiatrist or Neurologist. The primary outcome measures of the study are pain and severity of symptoms measured using Neuropathy Symptom Score (NSS). The other outcomes are quality of life, Michigan Neuropathy Score Scale, nerve conduction velocity (NCV), monofilament test, clinician and patient's global impression of change.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138802201044N3
Registration date:2009-10-10, 1388/07/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-10-10, 1388/07/18
Registrant information
Name
Pezhman Madani
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0088
Email address
pezhman@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
ParsRoos Company
Expected recruitment start date
2009-10-10, 1388/07/18
Expected recruitment end date
2010-10-10, 1389/07/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Multi-Centre, Randomised, Double-Blind, Placebo Controlled Trial of the Effect of Neurotec in Symptomatic Diabetic Neuropathy
Public title
Neurotec in Symptomatic Diabetic Neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Pain equivalent to 4 or more on a numerical scale between 0 and 10, Diagnosis of Diabetes Mellitus (Type 1 or 2) defined by American Diabetes Association criteria for at least 3 years, Haemoglobin A1C less than 10%, History of Diabetic Neuropathy for more than a year, Age more than 18 years and less than 60, diagnosis of neuropathy based on Michigan Neuropathy Screening Instrument
Exclusion Criteria:
Presence of uncontrolled or poor controlled DM, Presence of neuropathy due to other causes than DM, Receiving any investigational drug within 30 days prior to screening, Presence of active or infected diabetic wound, Amputation, Presence of any other systemic or chronic diseases such as: Myopathy, Vasculitis, Peripheral Vascular Diseases, Chronic hepatic or renal diseases, clinically complicating pulmonary, Cardiac, Hematologic, Gastrointestinal, Endocrine disease or Malignancy, Symptomatic degenerative joint disease, active radiculopathy or discopathy, spinal stenosis , active degenerative disc diseases, chronic sciatalgia, sacroiliac joint dysfunction or any chronic painful condition involving lower extremities, apparent or diagnosed psychological problem such as anxiety or depression, Diabetic Retinopathy or retinal haemorrhage, Pregnancy or intention of becoming pregnant during the study period (9 months), Inability to give informed consent according to the agreed process, Corticosteroid therapy, Any drug hypersensitivity, Radiotherapy, Chemotherapy or any immuosuppressive drug use, Electrolyte imbalance
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Endocrinology and Metabolism Research Centre
Street address
Fifth floor, Shariati hospital, North Kargar Ave., Tehran, Iran
City
Tehran
Postal code
14114
Approval date
empty
Ethics committee reference number
E-0062
Health conditions studied
1
Description of health condition studied
Diabetic Neuropathy
ICD-10 code
G63.2
ICD-10 code description
Diabetic polyneuropathy
Primary outcomes
1
Description
Pain
Timepoint
Baseline, every other week during treatment period (6 months) and every month during follow-up period (3 months)
Method of measurement
pain during the last 2 weeks prior to study visits through a Visual Alalogue Scale recorded daily by the patients in diary notebook
2
Description
Severity of neuropathy
Timepoint
Baseline, every other week during treatment period (6 months) and every month during follow-up period (3 months)
Method of measurement
Neuropathy symptom score
Secondary outcomes
1
Description
Nurve Conduction Velocity
Timepoint
Baseline, weeks 24 and 36
Method of measurement
Conduction velocity of tibial, proneal and sureal nerves
2
Description
Monofilament test
Timepoint
Baseline, weeks 8, 16, 24 and 36
Method of measurement
Monofilament test
3
Description
Existence and severity of peripheral neuropathy
Timepoint
Baseline, weeks 8, 16, 24 and 36
Method of measurement
Michigan Neuropathy Score
4
Description
Patient's Global Impression of Change (PGIC)
Timepoint
Baseline, every other week during treatment period and every month during follow-up period
Method of measurement
10-point rating scale from very poor condition (1) to very good (10)
5
Description
Quality of life
Timepoint
Baseline, weeks 16, 24 and 36
Method of measurement
SF-12 questionnaire
6
Description
Clinical Global Impression of Change (CGIC)
Timepoint
Baseline, every other week during treatment period and every month during follow-up period
Method of measurement
10-point rating scale from very poor condition (1) to very good (10) determined by the physician
Intervention groups
1
Description
Neurotec 120 mg (1 capsule) two times a day for 4 months and then 120 mg, 1 capsule a day for two month
Category
Treatment - Drugs
2
Description
Gabapentin 300 mg (1 capsule) two times a day for 4 months and then 300 mg, 1 capsule a day for 2 months
Category
Treatment - Drugs
3
Description
Placebo 1 identical capsule as active drug two times a day for 4 months and then 1 capsule a day for 2 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology and Metabolism Research Center, Tehram University of Medical Sciences