Effect of coenzyme Q10 versus placebo as an adjuvant therapy on pain in patients with painful diabetic neuropathy: a double-blind randomized clinical trial
To assess the effect of coenzyme Q10 versus placebo as an adjuvant therapy on pain in patients with painful diabetic neuropathy
Design
This is a double-blind randomized clinical trial, phase III, in which 116 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with painful diabetic neuropathy referring to the Imam Khomeini Clinic in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded so that neither patients nor the physician examining the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 70 years,
Type 2 diabetes for at least one year,
Painful diabetic neuropathy,
Exclusion criteria:
Pregnancy or breastfeeding,
Foot ulcer or infection,
Hemoglobin A1C equal to or less than 9,
Cerebrovascular diseases or discopathy,
Taking anti-inflammatory medications,
Using alcohol or opioids
Intervention groups
Intervention group:
Pregabalin tablet 75 mg (manufactured by Golden Life Pharmaceutical Co.) every 12 hours for 8 weeks plus coenzyme tablet Q10 100 mg (manufactured by Reyhaneh Pharmaceutical Co.) every 12 hours for 8 weeks
Control group:
Pregabalin tablet 75 mg (manufactured by Golden Life Pharmaceutical Co.) every 12 hours for 8 weeks plus placebo tablet including starch (manufactured by laboratory of School of Pharmacy, Hamadan) every 12 hours for 8 weeks
Main outcome variables
Primary outcome:
Mean score of painو ئean score of sleep disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N385
Registration date:2021-02-21, 1399/12/03
Registration timing:prospective
Last update:2021-02-21, 1399/12/03
Update count:1
Registration date
2021-02-21, 1399/12/03
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2022-02-04, 1400/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of coenzyme Q10 versus placebo as an adjuvant therapy on pain in patients with painful diabetic neuropathy: a double-blind randomized clinical trial
Public title
Effect of coenzyme Q10 versus placebo as an adjuvant therapy on pain in patients with painful diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 70 years,
Type 2 diabetes for at least one year,
Painful diabetic neuropathy,
Exclusion criteria:
Pregnancy or breastfeeding,
Foot ulcer or infection,
Hemoglobin A1C equal to or less than 9,
Cerebrovascular diseases or discopathy,
Taking anti-inflammatory medications,
Using alcohol or opioids
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2020-11-07, 1399/08/17
Ethics committee reference number
IR.UMSHA.REC.1399.678
Health conditions studied
1
Description of health condition studied
Painful diabetic neuropathy
ICD-10 code
E08.40
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified
Primary outcomes
1
Description
Mean score of pain
Timepoint
Before the intervention and at weeks 2 and 4 and 8 after the intervention
Method of measurement
using Visual Analog Scale (VAS)
2
Description
Mean score of sleep disorder
Timepoint
Before the intervention and at weeks 2 and 4 and 8 after the intervention
Method of measurement
Using the Patient Global Impression of Change (PGIC) and Clinical Global Impression of Change (CGIC) questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pregabalin tablet 75 mg (manufactured by Golden Life Pharmaceutical Co.) every 12 hours for 8 weeks plus coenzyme tablet Q10 100 mg (manufactured by Reyhaneh Pharmaceutical Co.) every 12 hours for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: Pregabalin tablet 75 mg (manufactured by Golden Life Pharmaceutical Co.) every 12 hours for 8 weeks plus placebo tablet including starch (manufactured by laboratory of School of Pharmacy, Hamadan) every 12 hours for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Clinic in Hamadan city
Full name of responsible person
Paryan Amini
Street address
Imam Khomeini Clinic, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3832 1371
Email
paryan.amini@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Paryan Amini
Position
Student of Pharmacy
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
paryan.amini@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Maryam Mehrpooya
Position
Clinical Pharmacologist
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
m_mehrpooya2003@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available