Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000388314
Ethics application status
Approved
Date submitted
20/07/2008
Date registered
4/08/2008
Date last updated
6/10/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety and efficacy of Neurotec in reducing pain in patients with diabetic neuropathy - a single armed phase II trial
Scientific title
Safety and efficacy of Neurotec in reducing pain in patients with diabetic neuropathy - a single armed phase II trial
Secondary ID [1] 632 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Neuropathy 3426 0
Condition category
Condition code
Metabolic and Endocrine 3581 3581 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral 120 mg capsules of Neurotec twice a day for 12 weeks and once a day for another 4 weeks - a herbal exract
Intervention code [1] 3157 0
Treatment: Drugs
Comparator / control treatment
There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4483 0
Pain measured by Visual Analogos Scale(VAS)
Timepoint [1] 4483 0
baseline, 2, 4, 8, 12, 16 and 24 weeks
Secondary outcome [1] 7583 0
Michigan Diabetic Neuropathy score
Timepoint [1] 7583 0
baseline, 2, 4, 8, 12, 16 and 24 weeks
Secondary outcome [2] 7584 0
UK Diabetic Neuropathy score
Timepoint [2] 7584 0
baseline, 2, 4, 8, 12, 16 and 24 weeks
Secondary outcome [3] 7585 0
Semmes-Weinstein monofilament test for peripheral sensory neuropathy
Timepoint [3] 7585 0
baseline, 2, 4, 8, 12, 16 and 24 weeks

Eligibility
Key inclusion criteria
having diabetic I or II
having pain and paresthesia interfering with every day activities
Diminished anckle reflex
Abnormal 128 Hz vibration test
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unwilling to sign a written consent
Non-diabetic neuropathy
Wound infection or infection in extremities
ischaemic heart disease
Heart failure
reeiving immunosuppresive drugs, corticosteroids, chemotherapy, radiotherapy
Alcohol and substance misuse
Electrolyte disturbances
History of known hypersensitivity to drugs
Haemodialysis

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 1045 0
Iran, Islamic Republic Of
State/province [1] 1045 0
Tehran

Funding & Sponsors
Funding source category [1] 3613 0
Commercial sector/Industry
Name [1] 3613 0
ParsRoos
Country [1] 3613 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Tehran University of Medical Sciences
Address
Ghods St.,
Keshavars beulevard,
Tehran, Iran
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 3246 0
Hospital
Name [1] 3246 0
Shariati Hospital
Address [1] 3246 0
North Karegar street,
Tehran, Iran
Country [1] 3246 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5660 0
Endocrine and Metablism research Centre Ethic committee
Ethics committee address [1] 5660 0
5th Floor, Shariati Hospital, North Karegar street, Tehran, Iran
Ethics committee country [1] 5660 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 5660 0
29/03/2008
Approval date [1] 5660 0
29/04/2008
Ethics approval number [1] 5660 0
E-0005

Summary
Brief summary
This is a phase II, single armed, trial of Safety and Efficacy of Neurotec, a herbal extract. After signing a consent form 10 paients will be recruited into this trial during which they will recieve oral capsules of Neurotec twice a day for 12 weeks and once a day for another 4 weeks. Every 2 weeks a detailed clinical and laboratory examination will be carried out. this will continue up to 24 weeks. Primary outcome measure is pain which will be measured on 2 week intervals. Secondary outcome measures are michigan and UK diabetic neuropathy score.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28765 0
Address 28765 0
Country 28765 0
Phone 28765 0
Fax 28765 0
Email 28765 0
Contact person for public queries
Name 11922 0
Ramin Heshmat
Address 11922 0
5th Floor,
Shariati Hospital,
North Karegar street,
Tehran, Iran
Country 11922 0
Iran, Islamic Republic Of
Phone 11922 0
0098-21-84902786
Fax 11922 0
0098-21-88029399
Email 11922 0
[email protected]
Contact person for scientific queries
Name 2850 0
pezhman madani
Address 2850 0
5th Floor,
Shariati Hospital,
North Karegar street,
Tehran, Iran
Country 2850 0
Iran, Islamic Republic Of
Phone 2850 0
0098-21-84902786
Fax 2850 0
0098-21-88029399
Email 2850 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.