Nowadays, people show an increasing interest in using natural products. In this study the effect of Diabetan pill that is a blend of Saliva officinalis, Trigonella foenum and Ginseng will be investigated on blood glucose of diabetic patients.
Methods: In a double-blind clinical trial 80 diabetic patients referred to endocrine and metabolism clinic in Shahrekord (Iran) will be selected and randomly designated into two groups of case and control. The case group will receive Diabetan and the control group will receive placebo tablets three times a day for three months. Glycosylated hemoglobin, lipid profile, fasting blood sugar (FBS) and 2 hours postprandial (2hpp) will be measured at the beginning and every 2 weeks, for three months. Hepatic enzymes will also evaluated and compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011112696N2
Registration date:2010-12-18, 1389/09/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-12-18, 1389/09/27
Registrant information
Name
Mahmoud Rafieian-kopaei
Name of organization / entity
Shaharekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1334 6692
Email address
rafieian@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Gol Daru Company
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2011-02-20, 1389/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Diabetan and Saliva officinalis L tablets on blood glucose levels of patients with type 2 DM.
Public title
Effects of Diabetan and Saliva officinalis L tablets on blood glucose levels of patients with type 2 DM.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: 1-Having type 2 diabetes based on internal criteria with FBS=126 or more and blood glucose 200 or more in daytime. 2- HbA1C more than 7% and less than 9% 3-Not having side effects of DM 4-Non- insulin dependent 5-Willing to participate in the trial 6-Not having a crucial illness 7- psychologically normal 8- Not using any other drugs for other diseases. Excluding Criteria: 1- Hyperglycemia with HbA1C more than 250 2-2hpp more than 9% and less than 7% 3-Pragnancy and lactation 4- Using insulin 5- Not willing to enter the trial 6- Having side effects of DM 7- Cardiovascular, hepatic, renal and other major systemic diseases 8- psychologically abnormal 9- Using drugs for other illnesses 10- Type 1 DM 11- Age less than 30 years
Age
From 30 years old to 149 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
N/A
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
ٍEthical commitee of Shahrekord University of Medical Sciences
Street address
Shahrekord, kashani St, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Approval date
2010-04-11, 1389/01/22
Ethics committee reference number
87-11-2
Health conditions studied
1
Description of health condition studied
Diabetes Melitus (DM)
ICD-10 code
E10, E11,
ICD-10 code description
Diabetes Melitus
Primary outcomes
1
Description
HbA1C
Timepoint
At the beginning and at the end of trial (in 3 months
Method of measurement
Laboratory mg/ dl
2
Description
Lipid profile
Timepoint
At the beginning and end of the trial (in 3 months)
Method of measurement
mg/dl through lab methods
3
Description
Liver and kidney parameters
Timepoint
At the beginning and end of the trial (in 3 months)
Method of measurement
mg/dl through lab methods
4
Description
FBS and HbA1C
Timepoint
at the beginning of trial and every 2 weeks
Method of measurement
mg/dl
Secondary outcomes
empty
Intervention groups
1
Description
Diabetan tablet will be prescribed for them 3 times per day for three months
Category
Treatment - Drugs
2
Description
Placebo tablet will be prescribed 3 times per day for three months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Metabolism clinic of Shahrekord University of Medical Sciences
Full name of responsible person
Mohamad Saeed Behradmanesh
Street address
Metabolism clinic of Shahrekord University of Medical Sciences
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gol Daru Co.
Full name of responsible person
Dr Falamarzian
Street address
Isfahan-Sofeh Shahrak-Gol Daru
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gol Daru Co.
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
Shahrekord University of Medical Sciences
Full name of responsible person
Dr Mohamad Saeed Behradmanesh
Position
Specialist
Other areas of specialty/work
Street address
Sharekord, Shahrekord University of Medical Sciences,
City
Shahrekord
Postal code
Phone
+98 38 1333 0709
Fax
+98 38 1333 0709
Email
behradmanesh@skums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr Mohamad Saeed Behradmanesh
Position
Specialist
Other areas of specialty/work
Street address
Shahrekord Univercity of Medical Sciences, Kashani St,
City
Shahrekord
Postal code
Phone
+98 38 1333 0709
Fax
+98 38 1333 0709
Email
behradmanesh@skums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr Mohamad Saeed Behradmanesh
Position
Specialist
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38 1333 0709
Fax
+98 38 1333 0709
Email
behradmanesh@skums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)