Comparison of the effect of nortriptyline and melatonin on the severity of diabetic polyneuropathy
Design
A randomized, parallel, double-blind, placebo-controlled clinical trial
Settings and conduct
This study will be done on patients referred to endocrinology clinic of Ayatolah Rouhani`s hospital. One group of patients will be given 25 mg of nortriptyline and the other group will be given 3 mg of melatonin. Patients' pain will be assessed at the beginning of the study, at the end of the second week, and at the end of the study based on the VAS (Visual Analogue Scale) scale.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all patients with diabetic neuropathy aged 30-65 years.
Exclusion criteria: pregnancy, metabolic and bone diseases, and drug allergy.
Intervention groups
One group received nortriptyline and one group received melatonin
Main outcome variables
Neuropathic pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191030045277N2
Registration date:2020-10-15, 1399/07/24
Registration timing:retrospective
Last update:2020-10-15, 1399/07/24
Update count:0
Registration date
2020-10-15, 1399/07/24
Registrant information
Name
mohammadali bayani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8284
Email address
bayanima49@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of nortriptyline and melatonin on the severity of diabetic polyneuropathy
Public title
The effect of nortriptyline and melatonin on diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with diabetic neuropathy
Exclusion criteria:
Pregnancy and lactation
Recent Myocardial Infarction
Sensitivity to medications (nortriptyline and melatonin)
History of seizures
Mood disorder
Gastroparesis and diabetic cystopathy,
Liver and Renal failure
hypothyroidism and hyperthyroidism
people with arthritis
Hereditary neuropathies
People with a history of trauma and degenerative bone lesions
Age
From 30 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random block method with block size 4 (AABB) and the number of blocks 15, patients will be randomly divided into two groups. According to www.randomization.com, Block of 4 will be produced 15 times. To group patients, it will be written on a sheet and assigned to patients. Each patient will be randomly assigned to one of the treatment groups (nortriptyline and melatonin) while receiving the drug, according to the sequence obtained.
Blinding (investigator's opinion)
Double blinded
Blinding description
Melatonin and nortriptyline will be prepared in identical opaque capsules and will be placed in exactly the same cans and packages, and the coding will be done according to a random table. None of the participants, principal investigator, health care personnel (physicians, nurses, etc.) will be responsible for patient care (etc.), data collectors and statistical analysts, will not be aware of patient received package and the coding.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganjafruze road, Babol town
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2020-01-18, 1398/10/28
Ethics committee reference number
IR.MUBABOL.HRI.REC.1398.288
Health conditions studied
1
Description of health condition studied
Diabetic polyneuropathy
ICD-10 code
E10.42
ICD-10 code description
Type 1 diabetes mellitus with diabetic polyneuropathy
2
Description of health condition studied
Diabetic polyneuropathy
ICD-10 code
E11.42
ICD-10 code description
Type 2 diabetes mellitus with diabetic polyneuropathy
Primary outcomes
1
Description
Severity of neuropathy
Timepoint
At the beginning of the study (first day) and at the end of the second week and at the end of the study (end of the fifth week).
Method of measurement
Based on the VAS (Visual Analogue Scale)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group : Patients in this group will be treated with nortriptyline 25 mg (Sobhan Pharmaceutical Company). Its duration will be 35 days.
Category
Treatment - Drugs
2
Description
Intervention group: Patients in this group will be treated with 3 mg melatonin (Razak Pharmaceutical Company) daily.Its duration will be 35 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rohani Hospital
Full name of responsible person
Mohammadali Bayani
Street address
Ganj Afrooz Road, Babol Rohani Hospital
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3223 8309
Email
info@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohammadali Bayani
Street address
Ganj Afrooz Road, Babol Rohani Hospital
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3223 8309
Email
Info@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohammadali Bayani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinologist and Metabolism Specialist
Street address
Ganj Afrooz Road, Babol Rohani Hospital
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3223 8309
Email
bayanima49@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohammadali Bayani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinologist and Metabolism Specialist
Street address
Ganj Afrooz Road, Babol Rohani Hospital
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3223 8309
Email
bayanima49@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohammadali Bayani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinologist and Metabolism Specialist
Street address
Ganj Afrooz Road, Babol Rohani Hospital
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3223 8309
Email
bayanima49@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
A portion of the data related to the main topic is displayed.
When the data will become available and for how long
Start of access period 6 months after printing result.
To whom data/document is available
It will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
No special conditions
From where data/document is obtainable
Babol University of Medical Sciences, Internal Education, Dr. Mohammad Ali Bayani
What processes are involved for a request to access data/document
Refer to internal training and talk to Dr. Bayani and access to information