Study of the effect of hydroalcholic extract of lavandula officinalis on some biochemical factors in blood and urine in diabetic patients
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2-3 on 80 patients. Random allocation software was used for randomization.
Settings and conduct
The present study was performed in Imam Ali Clinic affiliated to Shahrekord University of Medical Sciences in 1398.
Participants/Inclusion and exclusion criteria
Diabetic patients between the ages of 30 and 60 years without significant concomitant underlying disease and no insulin intake
Intervention groups
The drug group received two lavender capsules daily for 2 months
and the control group received two placebo capsules daily for 2 months.
Tests checked twice before and after taking the medication.
Main outcome variables
FBS, lipid profile, BUN, Cr, HbA1C, urine protein and urine sugar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200826048534N1
Registration date:2020-09-12, 1399/06/22
Registration timing:retrospective
Last update:2020-09-12, 1399/06/22
Update count:0
Registration date
2020-09-12, 1399/06/22
Registrant information
Name
Sanaz Hojatyar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3263 2006
Email address
sanazhojatyar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
2019-05-22, 1398/03/01
Actual recruitment end date
2019-08-06, 1398/05/15
Trial completion date
2019-10-23, 1398/08/01
Scientific title
Study of the Effect of Hydroalcholic Extract of Lavandula Officinalis on Some Biochemical Factors in Blood and Urine in Diabetes.
Public title
Effect of Lavandula Officinalis in treatment of diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of diabetes
Patients aged 30 to 60 years
Fasting blood sugar ≥126 mg / dl
Intravenous blood serum glucose 200 mg/dl, 2 hours after ingestion of 75 g of oral glucose
Not receiving insulin
HbA1C from 7 to 8.5
Diagnosis of diabetes is less than 10 years
Use only oral antihyperglycemic drugs(Metformin,Glibenclamide)
A total of 80 diabetic patients referred to Imam Ali Clinic in Shahrekord according to the number of patients referred (diagnosis number) and grouping A and B (which was not clear to patients and the person responsible for patient selection , which group of drugs and which placebo) through Random Allocaton statistical software related to simple randomization method was obtained and entered into each of the relevant groups (with random numbers Computer software that divided the numbers 1 to 80 into simple groups A and B by simple randomization. It was determined which number of patient be in which group A or B.)
Blinding (investigator's opinion)
Double blinded
Blinding description
None of the patients knew in which group (drug or control) they were.
The person responsible for patient selection was also unaware of which of A or B group was the drug or placebo group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Shahrekord, Kashani Blvd., University Headquarters, Building No. 2
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2018-05-26, 1397/03/05
Ethics committee reference number
IR.SKUMS.REC.1397.044
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E10-E14
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Fasting blood sugar
Timepoint
At the beginning of the study and 2 months after consumption of drugs
Method of measurement
With special kits by an autoanalyzer system
2
Description
HbA1C
Timepoint
At the beginning of the study and 2 months after consumption of drugs
Method of measurement
With special kits by an autoanalyzer system
3
Description
Cholestrol
Timepoint
At the beginning of the study and 2 months after consumption of drugs
Method of measurement
With special kits by an autoanalyzer system
4
Description
Very low density lipoprotein
Timepoint
At the beginning of the study and 2 months after consumption of drugs
Method of measurement
With special kits by an autoanalyzer system
5
Description
Low density lipoprotein
Timepoint
At the beginning of the study and 2 months after consumption of drugs
Method of measurement
With special kits by an autoanalyzer system
6
Description
High density lipoprotein
Timepoint
At the beginning of the study and 2 months after consumption of drugs
Method of measurement
With special kits by an autoanalyzer system
7
Description
Triglyceride
Timepoint
At the beginning of the study and 2 months after consumption of drugs
Method of measurement
With special kits by an autoanalyzer system
8
Description
Alanine transaminase
Timepoint
At the beginning of the study and 2 months after consumption of drugs
Method of measurement
With special kits by an autoanalyzer system
9
Description
Aspartate aminotransferase
Timepoint
At the beginning of the study and 2 months after consumption of drugs
Method of measurement
With special kits by an autoanalyzer system
10
Description
Blood urea nitrogen
Timepoint
At the beginning of the study and 2 months after consumption of drugs
Method of measurement
With special kits by an autoanalyzer system
11
Description
Creatinine
Timepoint
At the beginning of the study and 2 months after consumption of drugs
Method of measurement
With special kits by an autoanalyzer system
12
Description
Urine sugar
Timepoint
At the beginning of the study and 2 months after consumption of drugs
Method of measurement
With urine strip dip stick
13
Description
Urine protein
Timepoint
At the beginning of the study and 2 months after consumption of drugs
Method of measurement
With urine strip dip stick
14
Description
Body mass index
Timepoint
At the beginning of the study and 2 months after consumption of drugs
Method of measurement
It was measured and calculated with a tape measure and Ska scale (weight in kilograms divided by height to the power of 2 in square meters).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 40 diabetic patients who, in addition to routine medications used by diabetic patients (Metformin, Glibenclamide), received 2, 500 mg capsules containing Lavender extract daily, 2 times in the morning and at night.
Category
Treatment - Drugs
2
Description
Control group: 40 diabetic patients who, in addition to routine medications(Metformin,Glibenclamide) used by diabetic patients, received 2 placebo capsules twice daily before meals.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Clinic
Full name of responsible person
Sanaz Hojatyar
Street address
Shahrekord, Shariati Boulevard, Imam Ali Specialized Clinic
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3224 2696
Email
info@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehraban Sadeghi
Street address
Shahrekord, Kashani Blvd., University Headquarters, Building No. 2
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 2414
Email
vcrt@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Leila Mahmudnia
Position
Aَssistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shahrekord, Rahmatieh, Shahrekord University of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8158166356
Phone
+98 38 3333 9940
Email
mahmudnia.L@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Leila Mahmudnia
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shahrekord, Rahmatieh, Shahrekord University of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8158166356
Phone
+98 38 3333 9940
Email
mahmudnia.L@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Leila Mahmudnia
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shahrekord, Rahmatieh, Shahrekord University of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8158166356
Phone
+98 38 3333 9940
Email
mahmudnia.L@skums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available