This is a phase II, single armed, trial of Safety and Efficacy of Neurotec, a herbal extract. After signing a consent form 14 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.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138705221044N1
Registration date:2008-09-05, 1387/06/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2008-09-05, 1387/06/15
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
Pars Roos Company, Tehran, Iran
Expected recruitment start date
2008-08-01, 1387/05/11
Expected recruitment end date
2008-08-10, 1387/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy of oral form of Neurotec in reduction of pain in patients with diabetic neuropathy, A phase II clinical trial
Public title
Safety and efficacy of oral form of Neurotec in reduction of pain in patients with diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
having diabetic I or II
having pain and paresthesia interfering with every day activities
Diminished anckle reflex
Abnormal 128 Hz vibration test
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
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
14
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
1
Registry name
ANZCTR
Secondary trial Id
ACTRN12608000388314
Registration date
2008-04-08, 1387/01/20
Ethics committees
1
Ethics committee
Name of ethics committee
Endocrine and Metablism research Centre Ethic committee
Street address
5th Floor, Shariati Hospital, North Karegar street, Tehran, Iran
City
Tehran
Postal code
14114
Approval date
empty
Ethics committee reference number
E-0005
Health conditions studied
1
Description of health condition studied
Diabetic neuropathy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain measured by Visual Analogos Scale(VAS)
Timepoint
baseline, 2, 4, 8, 12, 16 and 24 weeks
Method of measurement
measured by Visual Analogos Scale(VAS)
Secondary outcomes
1
Description
Michigan Diabetic Neuropathy score
Timepoint
baseline, 2, 4, 8, 12, 16 and 24 weeks
Method of measurement
Questionaire
2
Description
UK Diabetic Neuropathy score
Timepoint
baseline, 2, 4, 8, 12, 16 and 24 weeks
Method of measurement
Questionaire
3
Description
Semmes-Weinstein monofilament test for peripheral sensory neuropathy
Timepoint
baseline, 2, 4, 8, 12, 16 and 24 weeks
Method of measurement
Monofilament test
Intervention groups
1
Description
Oral form of drug Neurotec 120 mg capsules, 2 capsules a day for 16 weeks and 1 capsule a day for another 8 weeks
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrine and Metablism research Centre
Full name of responsible person
Dr.Pezhman madani
Street address
5th Floor, Shariati Hospital, North Karegar street, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Endocrine and Metablism research Centre
Full name of responsible person
Ramin Heshmat
Street address
5th Floor, Shariati Hospital, North Karegar street, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocrine and Metablism research Centre
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
EMRC
Full name of responsible person
Ramin Heshmat
Position
Epidemiologist
Other areas of specialty/work
Street address
5th Floor, Shariati Hospital, North Karegar street,Tehran, Iran
City
Tehran
Postal code
14114
Phone
+98 21 8490 2786
Fax
+98 21 8802 9399
Email
pezhman@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
EMRC
Full name of responsible person
pezhman madani
Position
Medical physics and rahbilitation specialist
Other areas of specialty/work
Street address
5th Floor, Shariati Hospital, Tehran, Iran
City
Tehran
Postal code
14114
Phone
+98 21 8490 2786
Fax
+98 21 8802 9399
Email
pezhman@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
EMRC
Full name of responsible person
Dr.pezhman madani
Position
Medical physics and rehabilitation specialist
Other areas of specialty/work
Street address
5th Floor, Shariati Hospital, North Karegar street, Tehran, Iran
City
Tehran
Postal code
14114
Phone
+98 21 8490 2786
Fax
+98 21 8802 9399
Email
pezhman@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)