Determining and comparing the mean score of neuropathy severity in study groups: topical Nigella Sativa product, placebo (topical) and gabapentin capsule
Design
A randomized controlled clinical trial with parallel, double-blind, randomized groups
Settings and conduct
The study will be conducted at the Yazd Diabetes Research Center. Patients will be diagnosed by a neurologist. We then randomly divide the participants into three groups. The first group will receive topical Nigella Sativa (ointment), the second group topical placebo and the last group will receive gabapentin 300 mg capsules.
Patients will be followed for 8 weeks. The first follow-up is at the end of the second week (to check for complications and adherence of patients) and the second follow-up is at the end of the fourth week and the third follow-up is at the end of the 8 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
Type 2 diabetes mellitus
with diabetic neuropathy diagnosed by neurologist
resident of Yazd
controlled glucose (HbA1c less than 9)
exclusion criteria :
Spinal Disorders and Discopathy
Heart disorder
Renal disorder
Liver disorder
Active foot ulcer
Autoimmune diseases
mental illnesses
Drug and alcohol addiction
Skin diseases in the area of drug use
Severe foot vascular disorders
Intervention groups
The first group : topical Nigella Sativa (ointment)
The second group : topical placebo (ointment)
The last group : gabapentin 300 mg
Main outcome variables
Severity of neuropathy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160221026684N2
Registration date:2022-02-22, 1400/12/03
Registration timing:retrospective
Last update:2022-02-22, 1400/12/03
Update count:0
Registration date
2022-02-22, 1400/12/03
Registrant information
Name
Seyed Ali Khodaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3728 0215
Email address
sa.khodaei@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of topical Nigella Sativa product and gabapentin capsule on diabetic peripheral neuropathy
Public title
The effect of Nigella Sativa on diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes mellitus
with diabetic neuropathy diagnosed by neurologist
resident of Yazd
controlled glucose (HbA1c less than 9)
Exclusion criteria:
Spinal Disorders and Discopathy
Heart disorder
Renal disorder
Liver disorder
Active foot ulcer
Autoimmune diseases
mental illnesses
Drug and alcohol addiction
Skin diseases in the area of drug use
Severe foot vascular disorders
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Random method: Simple random
Random double blind
Referral by a neurologist
120 envelopes: 40 pieces A (treatment), 40 pieces B (placebo), 40 pieces C (gabapentin) sealed and closed, in front of the secretary. Upon arrival, each patient is given a random envelope. The secretary only provides packages containing materials A, B and C to patients and does not know their contents.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, only the principal investigator and outcome assessor are aware of the contents of the envelope. Patients and others involved in the design have no information about the type of material in the envelopes. Drug and placebo are similar in shape, color, odor, packaging, and appearance, and blinding has been performed between them. Gabapentin capsule group is the standard treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahid sadoughi university of medical sciences
Street address
Diabetes Research Center, Talar-e-Honar Alley, Shahid Sadoughi Blvd, Yazd
City
yazd
Province
Yazd
Postal code
8917693571
Approval date
2019-07-30, 1398/05/08
Ethics committee reference number
IR.SSU.REC.1398.077
Health conditions studied
1
Description of health condition studied
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
Severity of peripheral neuropathy
Timepoint
before intervention and 2, 4 , 8 weeks after intervention
Method of measurement
MICHIGAN NEUROPATHY SCREENING INSTRUMENT
Secondary outcomes
1
Description
HbA1c
Timepoint
before intervention and 8 weeks after intervention
Method of measurement
Chromatography (HPLC)
Intervention groups
1
Description
First intervention group: topical Nigella Sativa product. This product is prepared from aqueous extract of black seed and base cream in the form of 10% ointment, used twice a day (morning and night before bed) and for 8 weeks on both patients' feet. The amount of ointment used each time is the size of a fingertip, which is massaged from top to bottom. The drug is formulated in Behdanebaran pharmaceutical company.
Category
Treatment - Drugs
2
Description
Control group: topical placebo- This product is prepared from a base cream and black paint in the form of an ointment, used twice a day (morning and night before bed) and for 8 weeks on both patients' feet. The amount of ointment used each time is the size of a fingertip, which is massaged from top to bottom. The placebo is formulated in Behdanebaran pharmaceutical company
Category
Placebo
3
Description
Second intervention group: Gabapentin 300 mg capsules- In this group, patients receive a 300 mg gabapentin capsule orally every night before bed for 8 weeks. Capsules are manufactured by JALINOUS Pharmaceutical Company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Research Center
Full name of responsible person
seyedalikhodaie
Street address
Talar-e-Hanar Alley, North Shahid Sadoughi Blvd
City
yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3728 0215
Fax
+98 35 3728 0216
Email
dr.seyedalikhodaie@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Talar-e-Hanar Alley, North Shahid Sadoughi Blvd
City
yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Fax
+98 35 3727 9898
Email
masoud_mirzaei@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
seyedalikhodaie
Position
Non-Academic Specialist Physician
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
North Shahid Sadoughi BLVD
City
yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3728 0215
Fax
+98 35 3728 0216
Email
dr.seyedalikhodaie@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
seyedalikhodaie
Position
Non-Academic Specialist Physician
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
North Shahid Sadoughi Blvd
City
yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3728 0215
Fax
+98 35 3728 0216
Email
dr.seyedalikhodaie@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
maryam askari
Position
master of science
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Yazd Diabetes Research Center, Talar-e-Honar Alley, Shahid Sadoughi Blvd
City
yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3728 0215
Email
askarim204@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
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
Nigella Sativa data
Data on the main outcome will be made available to other researchers with the permission of the first executor.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
Coordinate with project analyzer
From where data/document is obtainable
dr seyed ali khodaie :03537280215
dr.seyedalikhodaie@yahoo.com
What processes are involved for a request to access data/document
Request data from Yazd University of Medical Sciences, approval of the director of the Diabetes Research Center, approval of the first executor of the project