Evaluation of topical Citrullus colocynthis fruit oil efficacy in the pain, electrodiagnostic findings and quality of life of patients with painful peripheral diabetic neuropathy
aim of study:
Evaluation of topical Citrullus colocynthis fruit oil efficacy in treatment of painful peripheral diabetic neuropathy
Study design:
Randomized double blind placebo-controlled clinical trial
Study population:
Patients with painful diabetic neuropathy attending SUMS endocrinology clinic
Inclusion criteria:
Patients with diabetes mellitus with painful neuropathy
Exclusion criteria:
Another painful condition that was difficult to distinguish from painful diabetic peripheral neuropathy
Sample size:
60 patients (two groups)
Interventions:
Topical Citrullus colocynthis fruit oil/ vehicle oil
Time period:
12 week
Outcome measures:
Neuropathic Pain Scale (NPS) score
WHOQOL-BREF questionnaire score
Nerve Conduction velocity values
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108117297N1
Registration date:2015-01-19, 1393/10/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-19, 1393/10/29
Registrant information
Name
Mojtaba Heydari
Name of organization / entity
Shiraz university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 71 1235 7679
Email address
mheydari@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of topical Citrullus colocynthis fruit oil efficacy in the pain, electrodiagnostic findings and quality of life of patients with painful peripheral diabetic neuropathy
Public title
Topical Citrullus colocynthis fruit oil in painful peripheral diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Controlled type 1 or 2 diabetes mellitus;
Painful Peripheral diabetic neuropathy for more than 3 months;
Age more than 18 years old;
Patients consent on enrolling study and admitting study protocol
Exclusion criteria:
Other causes of pain in lower extremities like lumbar disk herniation;
Ulcerative lesions in lower extremities;
Dermatitis;
Pregnancy;
Lactation;
Citrullus colocynthis allergy;
Unstable cardiac, neurological or renal disease;
Diagnosed other types of neuropathy.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization type: Block randomization
Blinding with use of vehicle oil as placebo
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Vice chancellor for research, Shiraz University of Medical Sciences, Zand street, Shiraz, Iran.
City
Shiraz
Postal code
Approval date
2014-04-14, 1393/01/25
Ethics committee reference number
CT-9377-7007
Health conditions studied
1
Description of health condition studied
Painful diabetic polyneuropathy
ICD-10 code
G63.2
ICD-10 code description
Diabetic polyneuropathy
Primary outcomes
1
Description
Neuropathic Pain Scale (NPS) score
Timepoint
Before the study and 12 weeks after the intervention
Method of measurement
Visual Scale
Secondary outcomes
1
Description
Nerve Conduction velocity
Timepoint
Before the study and 12 weeks after the intervention
Method of measurement
m/s by NCV
2
Description
WHOQOL-BREF score
Timepoint
Before the study and 12 weeks after the intervention
Method of measurement
Questionnaire (standard)
Intervention groups
1
Description
Citrullus colocynthis fruit oil:
1cc three times per day, application on the plantar and dorsal foot surface , without massage
Category
Treatment - Drugs
2
Description
Vehicle oil (Sesame oil):
1cc three times per day, application on the plantar and dorsal foot surface , without massage
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences
Full name of responsible person
Mojtaba Heydari
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maohammad Hosein Dabaghmanesh
Street address
Vice chancellor for research, Shiraz University of Medical Sciences, Zand Street, Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mojtaba Heydari
Position
PhD candidate
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand Street, Shiraz, Iran
City
Shiraz
Postal code
7135744661
Phone
+98 71 1233 6541
Fax
+98 71 1233 6541
Email
meshkat_114@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mesbah Shams
Position
Assistant professor
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand Street, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 1233 7589
Fax
Email
shams@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mojtaba Heydari
Position
PhD candidate
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand Street, Shiraz, Iran
City
Shiraz
Postal code
0711
Phone
+98 23 36541
Fax
Email
meshkat_114@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)