This study is double blind randomized clinical trial that is planned for the comparison of the effects of topical capsaicin and topical amitriptyline in pain reduction of patients with painful diabetic neuropathy. The study population consists of type two diabetic patients. Patients with painful diabetic neuropathy with visual analogue scale equal and grater than four will be included. Patients with hepatic or renal failure, use of other drugs for pain reduction and HA1C≥9 will be excluded. After signing the informed consent, the eligible patients (100 patients) will be assigned randomly into two different groups: Capsaicin and amitriptyline. Patients in capsaicin group will receive 0.75% capsaicine cream three times a day on the feet. Patients in amitriptyline group will receive 2% amitriptyline cream three times a day on the feet. The primary outcome is pain reduction and will be assed by visual analogue scale at the end of each month up to three month. At the end of the study mean pain reduction will be compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201209238308N2
Registration date:2012-09-28, 1391/07/07
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-09-28, 1391/07/07
Registrant information
Name
Javad Kiani
Name of organization / entity
College of Medical Sciences, Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0155
Email address
javadkiani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2012-11-01, 1391/08/11
Expected recruitment end date
2013-05-01, 1392/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparsion of topical amitriptyline and topical capsaicn in pain reduction of painful diabetic neuropathy of type2 diabetic patients
Public title
Comparsion of amitriptyline and capsaicn in painful diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Type two diabetic patients with Painfull diabetic neuropathy Exclusion criteria: Duration of diabetes less than one year; Age <30 or >70 years; VAS<4; Type one diabetes; Other causes of neuropathy other than diabetes; Opiom or alcohol users; Use of other drugs for pain reduction; Hepatic or renal failure; HA1C≥9; Pregnancy or lactation; Ulcer or infection of foot; Hypersensitivity to pepper
Age
From 30 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committee
Street address
Hamedan University of Medical Scinces, Shahid fahmide street
City
Hamedan
Postal code
Approval date
2012-06-30, 1391/04/10
Ethics committee reference number
D/P/16/35/9/1282
Health conditions studied
1
Description of health condition studied
Painfull Diabetic Polyneuropathy
ICD-10 code
G63.2
ICD-10 code description
Diabetic polyneuropathy
Primary outcomes
1
Description
Pain intensity
Timepoint
At baseline, one, two and three month later
Method of measurement
Visual Analouge Scale
Secondary outcomes
1
Description
Any adverse effect
Timepoint
one, two and three month later
Method of measurement
Questioner
Intervention groups
1
Description
Intervention 1 : Capsaicin cream 0.75% three times a day on the feet (nearly 1 gram each time) for three month.
Category
Treatment - Drugs
2
Description
Intervention 2 : amitriptyline cream 2% three times a day on the feet (nearly 1 gram each time) for three month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Clinic
Full name of responsible person
Street address
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor of Research and Technology,Hamedan university of Medical Sciences
Full name of responsible person
Heydar Tavilani
Street address
Shahid Fahmideh Street, Hamedan university of Medical Sciences
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor of Research and Technology,Hamedan university of Medical Sciences
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
College of Medical Sciences, Hamedan University of Medical Sciences
Full name of responsible person
Javad Kiani
Position
Assistant Proffesor of Endocrinology
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Blv., Hamedan
City
Hamedan
Postal code
Phone
+98 81 1838 0704
Fax
Email
javadkiani@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
College of Medical Sciences, Hamedan University of Medical Sciences
Full name of responsible person
Javad Kiani
Position
Assistant Proffesor of Endocrinology
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Blv., Hamedan
City
Hamedan
Postal code
Phone
+98 81 1838 0704
Fax
Email
javadkiani@umsha.ac.ire
Web page address
Person responsible for updating data
Contact
Name of organization / entity
College of Medical Sciences, Hamedan University of Medical Sciences
Full name of responsible person
Javad Kiani
Position
Assistant Proffesor of Endocrinology
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Blv., Hamedan
City
Hamedan
Postal code
Phone
+98 81 1838 0704
Fax
Email
javadkiani@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)