The effects of standardized ginseng extract panaxs (G115 ®) on inflammatory biomarkers and glycated hemoglobin in patients with diabetes type 2: double blind randomized placebo controlled trial
The aim of this study was to investigate the effect of standardized ginseng extract panax (G115) on glycosylated hemoglobin and inflammatory biomarkers in patients with diabetes type 2.This study is a double blind randomized placebo controlled trial. Patients who have at least 40 years of age, use oral drug for controlling blood glucose, do not inject insulin and have not an allergy to ginseng will be enrolled randomly in 2 groups: ginseng extract and placebo. HBA1C, IL6, hsCRP, TNF are measured before and 8 weeks after the intervention. Ginseng extract group will receive 300 mg of standardized ginseng extract three times a day and every time 100 mg, 30 minutes before breakfast, lunch and dinner. Placebo group will receive placebo capsule (1 gr of Wheat flour) in same protocol with the other group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013040812949N1
Registration date:2013-05-25, 1392/03/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-25, 1392/03/04
Registrant information
Name
Meysam Alipour
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1333 3050
Email address
alipour.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapour University of Medical Sciences
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of standardized ginseng extract panaxs (G115 ®) on inflammatory biomarkers and glycated hemoglobin in patients with diabetes type 2: double blind randomized placebo controlled trial
Public title
Evaluation the effect of standardized ginseng extract on glycated hemoglobin levels and inflammatory biomarkers in patients with diabetes type 2.
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: age between 40 to 60 years, Minimum 2 years experience in diabete, Receiving medication to control blood sugar, Blood glucose≥126mg/dl
exclusion criteria: need to injection insulin, smoking, Pregnancy and lactation, Consumption Non-steroidal anti-inflammatory drugs, Diuretics, Corticosteroids
Age
From 40 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Avenue. Ahvaz
City
Ahvaz
Postal code
6135715794
Approval date
2013-02-28, 1391/12/10
Ethics committee reference number
ETH-712
Health conditions studied
1
Description of health condition studied
diabetes mellitus type 2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
HBA1C %
Timepoint
before and after 8 weeks intervention
Method of measurement
percent of HBA1C
Secondary outcomes
1
Description
inflammatory biomarkers
Timepoint
before and after 8 weeks intervention
Method of measurement
IL6,hsCRP,TNF
Intervention groups
1
Description
ginseng extract group will receive 300 mg of standardized ginseng extract(G115) three times a day and every time 100 mg , 30 minutes before breakfast , lunch and dinner
Category
Other
2
Description
placebo group will receive placeb0(1g Wheat flour) three times a day and every time 100 mg , 30 minutes before breakfast , lunch and dinner
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital Clinic
Full name of responsible person
Dr. Mehrnoosh Zakerkish
Street address
Golestan- Golestan Hospital Clinic
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feqhi
Street address
Golestan Blvd - Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
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, Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Meysam Alipour
Position
Student of MSc. of Nutrition
Other areas of specialty/work
Street address
Golestan Blvd, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 1444 6216
Fax
Email
Alipour.m@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Seyyed Ahmad Hosseini
Position
PhD of Clinical Biochemistry
Other areas of specialty/work
Street address
Golestan Blvd, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 1333 3050
Fax
Email
seyyedahmadhosseini@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Meysam Alipour
Position
Student of MSc. of Nutrition
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Alipour.m@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)