Evaluation anti-hyperlipidemia effect of Pistacia atlantica Desf. ssp. Kurdica versus placebo in diabetic patients: A triple blind randomized clinical trial
Objectives: To assess the anti-hyperlipidemia effect of Pistacia atlantica Desf. ssp. Kurdica versus placebo in diabetic patients.
Design: A triple blind randomized clinical trial.
Setting and conduct: The eligible diabetic patients who will refer to Shahid Beheshti Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 65 years; hypercholesterolemia; HbA1C between 6 to 10.
Exclusion criteria: Renal disease; Liver disorder; gastric problem; heart failure; brain disease; sensitivity to Pistacia Atlantica Kurdica; insulin usage; myopathy.
Intervention group: Tablet Atorvastatin 40 mg once a day for 2 months plus capsule including dried powder of Pistacia Atlantica Kurdica 2 gr once a day for 2 months.
Control group: Tablet Atorvastatin 40 mg once a day for 2 months plus capsule including starch 2 gr once a day for 2 months.
Primary outcome: (a) assessing serum cholesterol before and 1 and 2 months after intervention through laboratory test; (b) assessing blood sugar before and 1 and 2 months after intervention through laboratory test.
Secondary outcome: Assessing side effects including nausea and vomiting 1 and 2 months after intervention through history taking.
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201708109014N178
Registration date:2017-08-13, 1396/05/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-13, 1396/05/22
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation anti-hyperlipidemia effect of Pistacia atlantica Desf. ssp. Kurdica versus placebo in diabetic patients: A triple blind randomized clinical trial
Public title
Evaluation anti-hyperlipidemia effect of Pistacia atlantica Desf. ssp. Kurdica versus placebo in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 65 years; hypercholesterolemia; HbA1C between 6 to 10.
Exclusion criteria: Renal disease; Liver disorder; gastric problem; heart failure; brain disease; sensitivity to Pistacia Atlantica Kurdica; insulin usage; myopathy.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2017-07-08, 1396/04/17
Ethics committee reference number
IR.UMSHA.REC.1396.311
Health conditions studied
1
Description of health condition studied
Hyperlipidemia
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidaemia, unspecified
Primary outcomes
1
Description
assessing serum cholesterol
Timepoint
before and 1 and 2 months after intervention
Method of measurement
through laboratory test
2
Description
assessing blood sugar
Timepoint
before and 1 and 2 months after intervention
Method of measurement
through laboratory test
Secondary outcomes
1
Description
Assessing side effects including nausea and vomiting
Timepoint
1 and 2 months after intervention
Method of measurement
through history taking
Intervention groups
1
Description
Intervention group: Tablet Atorvastatin 40 mg once a day for 2 months plus capsule including dried powder of Pistacia Atlantica Kurdica 2 gr once a day for 2 months.
Category
Treatment - Drugs
2
Description
Control group: Tablet Atorvastatin 40 mg once a day for 2 months plus capsule including starch 2 gr once a day for 2 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Faezeh Safari Majd
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 and Technology, Hamadan 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
School of Pharmacy
Full name of responsible person
Faezeh Safari Majd
Position
Pharmacology Student
Other areas of specialty/work
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
f.safarimajd@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Pharmacy
Full name of responsible person
Dr Dara Dastan
Position
Pharmacologist
Other areas of specialty/work
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
d.dastan@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)