The evaluation of the topical effect of Chamomile Oil on improving neuropathy symptoms in controlleddiabetic patients attend Shiraz diabetes clinic in 2022 A randomized double-blinded controlled clinical trial
Determining the effectiveness of chamomile oil in improving neuropathy indicators in patients with controlled diabetes
Design
The study is conducted in the form of a double-blind controlled randomized clinical trial on 72 patients with diabetic neuropathy who referred to the clinic. Randomization is done by restricted randomization method.
Settings and conduct
The location of study is the diabetes section of Milad Clinic in Shiraz.
The patients are randomly divided into two separate groups and one group of patients is given chamomile oil based on sesame oil and the other group is given a placebo (paraffin). Patients after 2 months of using drug-placebo topically, twice a day; are evaluated and if the results of the final study are obtained, otherwise a secondary evaluation will be done at the end of 3 months. After three months, the Michigan questionnaire and DN4 questionnaire will be administered again for neurosimetry patients.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Over 18 years with diabetic neuropathy, controlled diabetes, treated with routine medications, neurothesiometer results between 15-25
Exclusion Criteria: Dissatisfaction, having wounds due to causes other than diabetes, suffering from other influential diseases
Intervention groups
The traditional product of chamomile oil based on sesame oil as a complementary medicine and paraffin oil as a placebo is given to two groups of cases and controls for three months and 15 drops are used topically twice a day in the morning and in the evening each time.
Main outcome variables
Sensitivity to vibration, Michigan questionnaire score, DN4 questionnaire score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240611062090N1
Registration date:2024-08-06, 1403/05/16
Registration timing:registered_while_recruiting
Last update:2024-08-06, 1403/05/16
Update count:0
Registration date
2024-08-06, 1403/05/16
Registrant information
Name
Mohammad Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3631 6885
Email address
dr.mohammad.amiri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-05, 1403/05/15
Expected recruitment end date
2024-09-05, 1403/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the topical effect of Chamomile Oil on improving neuropathy symptoms in controlleddiabetic patients attend Shiraz diabetes clinic in 2022 A randomized double-blinded controlled clinical trial
Public title
The evaluation of the topical effect of Chamomile Oil on improving neuropathy symptoms
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People over 18 years old with diabetic neuropathy
Being treated with routine medications to treat diabetes
The patient has controlled diabetes. (In controlled diabetes, the patient's HbA1c is less than 7)
Patients should be on gabapentin for diabetic neuropathy
The neurothesiometer results should be greater than 15 and less than 25
Having at least reading and writing literacy
Exclusion criteria:
The patient does not agree to participate in the study
Patients not receiving modern treatment for diabetes or abandoning treatment
The patient use other topical, oral or injectable drugs effective on neuropathy
The patient has skin allergy
The patient have other diseases affecting the results (lumbar disc, sciatica, radiculopathy, peripheral vascular disease, MS, nerve damage diseases such as tarsal tunnel syndrome, etc.).
Patients with foot or finger ulcers are excluded from the study due to the distortion of neurosimetry results
Use other treatments such as physiotherapy, ultrasound therapy and laser therapy.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
1- Random number sequence for random block numbers will be done using random number generator
2. Limitation will be used in this study. Mild and moderate neuropathy cases will be included in the study.
3. In this study, we will use the restricted randomization method (Stratified block randomization) with an allocation ratio of 1:1. The size of the blocks will be 4 and 6. The exclusive code of the blocks and the random assignment of each code will be at the disposal of the statistician.
Blinding (investigator's opinion)
Double blinded
Blinding description
Bottles containing oil are designed as non-transparent and look exactly the same, the information printed on the bottles will be exactly the same. The evaluation of entry and exit criteria is done by the treating doctor, and the treating doctor, nurse and other health service providers to the patient do not know about the assigned oil bottles and their contents. The random assignment of the unique codes printed on the oil bottles will not be revealed until the end of the study and evaluation of all patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences Central Building, Zand Street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2022-12-12, 1401/09/21
Ethics committee reference number
Ir.SUMS.MED.REC.1401.487
Health conditions studied
1
Description of health condition studied
Diabetic Neuropathy
ICD-10 code
E11.40
ICD-10 code description
Type 2 diabetes mellitus with diabetic neuropathy, unspecified
Primary outcomes
1
Description
Sensitivity to vibration
Timepoint
Before the intervention, 2 and 3 months after the start
Method of measurement
Neurothesiometer
2
Description
Michigan questionnaire score
Timepoint
Before the intervention, 2 and 3 months after the start
Method of measurement
Questionnaire
3
Description
DN4 questionnaire score
Timepoint
Before the intervention, 2 and 3 months after the start
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Fasting Blood Sugar (FBS)
Timepoint
Befor and After intervention
Method of measurement
Blood Test
Intervention groups
1
Description
Intervention group: The patients of the intervention group use chamomile oil in the base of sesame oil topically twice a day for 3 months.
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group use placebo (paraffin oil) topically twice a day for three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Milad Clinic
Full name of responsible person
Mohammad Amiri
Street address
West Ghodoosi
City
Shiraz
Province
Fars
Postal code
7186615869
Phone
+98 71 3630 2065
Email
milaad.clinic@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempur
Street address
Research and Technology Deputy, 7th Floor, Shiraz University of Medical Sciences Central Building, Zand Street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
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
50
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
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Amiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Unit 6, 3rd Floor, No. 48, 16 Alley, Afif Abad,Shiraz
City
Shiraz
Province
Fars
Postal code
7183835499
Phone
+98 71 3136 6885
Email
dr.mohammad.amiri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Ebrahim Zohali Nejad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Shiraz University of Medical Sciences Central Building, Zand Street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
zohalinm@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Amiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Unit 6, 3rd Floor, No. 48, 16 Alley, Afif Abad,Shiraz
City
Shiraz
Province
Fars
Postal code
7183835499
Phone
+98 71 3631 6885
Email
dr.mohammad.amiri@gmail.com
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available