Neuropathic pain is a chronic and progressive pain which is associated with the Neuropathic pain is a chronic disorder associated with the impairment and damage of nervous system. Overall 1% of the human population around the world and totally 2-8% of adolescents suffer from this disorder. In the management, various medications and interventions are applied. But according to the nature of the disorder which is commonly chronic, patient has to handle long period of management. Therefore, topical medication may have more advantages compared to the systemic drugs.
Accordingly, current study aimed to evaluate the effectiveness Ajwain cream in neuropathic foot burn via a double-blind randomized placebo-controlled clinical trial. Seed oil of Ajwain is considered as a potent medicament for neurological disorders in Traditional Persian Medicine.
Simple randomization was done for a sample of 92 patients as two groups (placebo and Ajwain). Patients were introduced to either placebo or Ajwain group. Inclusion criteria: nonpregnant adults with neuropathic pain diagnosis; diabetic neuropathy; postsurgical/posttraumatic neuropathic pain; pain persisted for 6 months or longer and presence of dynamic allodynia in the site of pain. Exclusion criteria: patients suffering from another type of pain; psychiatric disorder requires special intervention; history of hypersensitivity or allergic reactions to herbal medicament; pregnant volunteer. Intervention included Ajwain placebo group. Primary outcomes were considered as feet burn, allodynia, paraesthesia and numbness in patient’s feet while feet burn is the most important parameter. Analysis was based on using the Visual Analog Scale on a 0 to 10 Cm scale. Patients were asked to fulfill the questionnaire before starting the new drug, in the middle of the procedure and ending point (day30).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201248815N1
Registration date:2012-06-12, 1391/03/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-06-12, 1391/03/23
Registrant information
Name
Mohammad Mehdi Zarshenas
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1242 4255
Email address
zarm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-04-21, 1391/02/02
Expected recruitment end date
2012-10-23, 1391/08/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Ajwain cream in patients with neuropathic foot, a double blind randomized controlled clinical trial
Public title
Evaluation of Ajwain cream in patients with neuropathic foot
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria for this study were encompassing nonpregnant adults with neuropathic pain diagnosis; diabetic neuropathy; postsurgical/posttraumatic neuropathic pain; moderate to severe pain persisted for 6 months or longer and presence of dynamic tactile allodynia or hyperalgesia in the site of pain in patients with normal cognitive and cooperation.
In contrast, patients suffering from another type as severe as the above pain; a major depression or psychiatric disorder requiring special intervention; patients with history of hypersensitivity or allergic reactions to the essential oils or herbal medicament; children and pregnant volunteers and anybody who does not have the ability to participate were excluded.
Age
No age limit
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences
City
Zand Street
Postal code
Approval date
2011-10-09, 1390/07/17
Ethics committee reference number
CT 90 5802
Health conditions studied
1
Description of health condition studied
Neuropathic pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Change or any declines in foot burn in neuropathic foot
Timepoint
The first day of addmision, middle of the trial (the day 15) and the end (the day 30)
Method of measurement
visual analoge scale (from 0 to 10)
Secondary outcomes
empty
Intervention groups
1
Description
A double-blind randomized placebo-controlled clinical trial
Group of Ajwain cream:
Cream is an oil in water semisolid formulation which is made up of almond oil (10%), Beeswax (5%), Vaseline (10%), Tween 80 (1%), and essential oil of Carum copticum (10%).
Patients are introduced to apply 5cm of cream of cream on the affected area of their feet twice a day for 30 days.
Category
Treatment - Drugs
2
Description
double-blind randomized placebo-controlled clinical trial
Group of placebo cream
Placebo cream is an oil in water semisolid formulation which is made up of almond oil (20%), Beeswax (5%), Vaseline (10%) and Tween 80 (1%). Patients are introduced to apply 5cm of cream of cream on the affected area of their feet twice a day for 30 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Pharmacy, Shiraz University of Medical Sciences
Full name of responsible person
Mohammad M. Zarshenas
Street address
City
Shiraz
2
Recruitment center
Name of recruitment center
Imam Reza Cinic
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Gholamreza Hatam
Street address
Vice Chancellor for Research, 7th floor, Shiraz Univercity of Medical Sciences, Zand st
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, 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
Faculty of Pharmacy, Shiraz University of Medical Sciences
Full name of responsible person
Mohammad M. Zarshenas
Position
PhD candidate
Other areas of specialty/work
Street address
Department of Traditional Pharmact, faculty of Pharmacy, shiraz University of Medical Sciences, Rokn abad street, Shiraz
City
Shiraz
Postal code
Phone
+98 71124242468
Fax
Email
zarm@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Pharmacognosy
Full name of responsible person
Mahmoodreza Moein
Position
PhD in Pharmacognosy
Other areas of specialty/work
Street address
Rokn abad street, Faculty of Pharmacy
City
Shiraz
Postal code
Phone
+98 71124242468
Fax
Email
mrmoein@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Traditional Pharmacy, Faculty of Pharmacy, Shiraz
Full name of responsible person
Mohammad M. Zarshenas
Position
PhD candidate
Other areas of specialty/work
Street address
Roknabad Street
City
Shiraz
Postal code
Phone
+98 71124242468
Fax
Email
zarm@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)