Protocol summary
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Study aim
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To assess the effect of coenzyme Q10 versus placebo as an adjuvant therapy on pain in patients with painful diabetic neuropathy
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Design
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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
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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 8 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 8 hours for 8 weeks
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Main outcome variables
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Primary outcome:
Mean score of painو ئean score of sleep disorder
General information
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Reason for update
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Change in dose of under study medication
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120215009014N385
Registration date:
2021-02-21, 1399/12/03
Registration timing:
prospective
Last update:
2022-04-19, 1401/01/30
Update count:
1
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Registration date
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2021-02-21, 1399/12/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-05-05, 1400/02/15
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Expected recruitment end date
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2022-02-04, 1400/11/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of coenzyme Q10 versus placebo as an adjuvant therapy on pain in patients with painful diabetic neuropathy: a double-blind randomized clinical trial
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Public title
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Effect of coenzyme Q10 versus placebo as an adjuvant therapy on pain in patients with painful diabetic neuropathy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 70 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
116
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-11-07, 1399/08/17
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Ethics committee reference number
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IR.UMSHA.REC.1399.678
Health conditions studied
1
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Description of health condition studied
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Painful diabetic neuropathy
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ICD-10 code
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E08.40
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ICD-10 code description
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Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified
Primary outcomes
1
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Description
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Mean score of pain
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Timepoint
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Before the intervention and at weeks 2 and 4 and 8 after the intervention
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Method of measurement
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using Visual Analog Scale (VAS)
2
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Description
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Mean score of sleep disorder
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Timepoint
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Before the intervention and at weeks 2 and 4 and 8 after the intervention
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Method of measurement
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Using the Patient Global Impression of Change (PGIC) and Clinical Global Impression of Change (CGIC) questionnaires
Intervention groups
1
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Description
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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 8 hours for 8 weeks
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Category
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Treatment - Drugs
2
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Description
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Control group: Pregabalin tablet 75 mg (manufactured by Golden Life Pharmaceutical Co.) every 8 hours for 8 weeks plus placebo tablet including starch (manufactured by laboratory of School of Pharmacy, Hamadan) every 12 hours for 8 weeks
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hamedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available