Determining the effect of oral Clonidine on the symptoms of peripheral neuropathy in diabetic patients.
Design
In this clinical trial, 70 patients will be selected based on the inclusion criteria and will be randomly divided into experimental and control groups. Relevant questionnaires for each patient at the beginning of the study and 2, 4 and 8 weeks after the intervention. Will be filled in and then the information obtained will be evaluated. The study will use the Michigan Questionnaire, the McGill Pain Scale.
Settings and conduct
This study is performed among diabetic patients referred to Yasuj Diabetes Clinic who have neuropathy. Patients and the researcher of this study who has the task of examining patients unaware of how patients are treated and grouped. Patients are evaluated for 2 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. Patients with type 2 diabetes who have symptoms related to peripheral neuropathy.
2. No chronic diseases such as (cardiovascular disease, kidney disease and severe thyroid disorder), neurology or psychiatry
3. Are not pregnant or breastfeeding.
4. Do not take drugs that are effective in exacerbating or alleviating neuropathy
5. Age between 30 and 60 years old
Exclusion criteria
Having neuropathy for proven reasons other than diabetes
Severe hypersensitivity to clonidine
Intervention groups
In this study, patients were divided into two experimental groups who, in addition to receiving the usual treatment for diabetic neuropathy, (took gabapentin) from clonidine at a dose of 0.2 mligram.The control group will also receive the usual treatment.
Main outcome variables
Severity of neuropathy, pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211106052983N1
Registration date:2022-01-14, 1400/10/24
Registration timing:prospective
Last update:2022-01-14, 1400/10/24
Update count:0
Registration date
2022-01-14, 1400/10/24
Registrant information
Name
soraya bagheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 3707
Email address
psyhosein67@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-16, 1400/10/26
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral Clonidine on the symptoms of peripheral neuropathy in diabetic patient. Randomized clinical trial.
Public title
The effect of oral Clonidine on the treatment of diabetic neuropathy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes who have symptoms associated with peripheral neuropathy.
No chronic illness (cardiovascular, renal and thyroid disorders), severe neurology or psychiatry.
Do not be pregnant or breastfeeding.
Not taking medications that are effective in exacerbating or alleviating neuropathy.
Age between 30 and 60 years old.
Exclusion criteria:
Having severe sensitivity to Clonidine
Having neuropathy with proven reasons except Diabetes
Age
From 30 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
They will be randomly divided into experimental and control groups. Randomization is by envelops or Cards shuffling method.
In this method, a number of cards selected by the researcher as the first group and the same number of cards for the next groups are considered; Then, by merging the cards with each other, a card is picked up and its allocation is recorded, and that card is returned to the total of the other cards. The cards are then merged again and another card is picked up. This process continues until a random sequence is reached according to the sample size. Also, the number of cards is not necessarily equal to the total number of samples. For example, in a three-group study with a sample size of 300 people and a ratio of 1: 1 groups, 3 cards can be prepared for each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher performs clinical examination and registers information without knowing the group of patients
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yasouj University of Medical Sciences
Street address
No. 1, First floor dormitory complex, Saheli Street, in front of Imam Sajjad Hospital.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591683677
Approval date
2021-04-08, 1400/01/19
Ethics committee reference number
.1400.008 .IR. YUMS. REC
Health conditions studied
1
Description of health condition studied
Diabet- Diabetic neuropathy.
ICD-10 code
E11.40
ICD-10 code description
Type 2 diabetes mellitus with diabetic neuropathy, unspecified.
Primary outcomes
1
Description
Severity of neuropathy in this study based on the Michigan Questionnaire, pain based on the McGill Pain Questionnaire.
Timepoint
Before the start of the study and 14, 28, 56 days later.
Method of measurement
The Michigan Questionnaire, the McGill Questionnaire, and the researcher-designed questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with diabetic neuropathy will be treated with Gabapentin 100 mg every night and clonidine 0.2 mg every morning
Category
Treatment - Drugs
2
Description
Control group: Patients with diabetic neuropathy will be treated with gabapentin 100 mg capsule every night.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofateh Clinic - Diabetes Clinic
Full name of responsible person
Soraya Bagheri
Street address
Second floor, Diabetes Clinic, Mofteh Clinic,Army Boulevard.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591683677
Phone
+98 74 3323 3707
Email
Psyhosein67@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Amir Hossein Dousti Mtlagh
Street address
Yasuj University of Medical Sciences, School of Medicine
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591683677
Phone
+98 74 3334 6079
Email
psyhosein67@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Soraya Bagheri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No. 1 dormitory complex in front of Imam Sajjad Hospital, Saheli Street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591683677
Phone
+98 74 3323 3707
Email
psyhosein67@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Majid Ahmadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Yasuj, Montazeri Street, in front of the electricity office
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591738841
Phone
+98 74 3322 3645
Email
majidahmadi1385@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Soraya Bagheri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No. 1, First Floor, Specialist doctors building, Dormitory complex , In front of Imam Sajad Hospital, Saheli Street, Yasuj City
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591683677
Phone
+98 74 3323 3707
Fax
Email
psyhosein67@gmail.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be 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
Not applicable
Title and more details about the data/document
The spss data file includes groups, main variables and demographic variables
When the data will become available and for how long
After publishing the article extracted from the plan
To whom data/document is available
Those who have corresponded with the responsible author and have the necessary reason to receive the file
Under which criteria data/document could be used
We have not made a decision in this case and a decision will be made after reviewing the request
From where data/document is obtainable
Seyed Majid Ahmadi
What processes are involved for a request to access data/document
The applicant should send his request via email and after obtaining permission from all project partners, if the partners agree with his request, the data will be sent to him.