The aim of the present study is to find a combination herbal formulation of Aloe vera gel and fenugreek seeds for improving symptoms of diabetes type 2. After quality and quantity control of herbal materials and pharmacological study (in vivo), antidibetic effects of the herbal product is evaluated during clinical trial. A total of 60 patients with diagnosed diabetes mellitus type 2 randomly assigned to take either drug or placebo in a double-blind design. For two month, the patients should receive one tablet orally per day. Changes in blood glucose and plasma insulin levels are monitored at the 4th and 8th weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109207602N1
Registration date:2015-01-06, 1393/10/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-06, 1393/10/16
Registrant information
Name
Parisa Sarkhail
Name of organization / entity
Pharmaceutical Sciences Research Centerو Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6412 2326
Email address
sarkhail@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran's National Elites Foundation (INEF)
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of a new herbal formulation for improving blood sugar control in patients with type 2 diabetes mellitus.
Public title
The effect of herbal supplement in type 2 diabetes treatment.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:newly diagnosed diabetes according to ADA 2014 (FPG=>126 mg/dl or HgA1C=>6.4% or BS=>200 mg/dl after OGTT or random BS =>200 and hyperglycemic symptoms); age 30-65 years; signed consent form.
Exclusion criteria: Diabetes type 1; insulin injection during 8 weeks ago; serious infectious diseases; renal failure (GFR< 50 cc/min/); liver failure ( high ALTor/and AST more than 3 times above normal range); cardiac failure; pregnancy and/or breast feeding; past history of seizure or epilepsy.
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Vice- Chancellor for Research,Tehran University of Medical Sciences
Street address
Blv. Keshavarz, Ghods St.
City
Tehran
Postal code
Approval date
2011-10-19, 1390/07/27
Ethics committee reference number
90/د/130/1305
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
Blood Glucose
Timepoint
In the beginning and at the end of 4th and 8th weeks of the trial.
Method of measurement
Blood test
Secondary outcomes
1
Description
Blood insulin
Timepoint
In the beginning and at the end of 4th and 8th weeks of the trial.
Method of measurement
Blood test
2
Description
Cholesterol and triglyceride
Timepoint
In the beginning and at the end of 8th week of the trial.
Method of measurement
Blood test
Intervention groups
1
Description
The placebo will be prescribed one tablet orally per day to the control group for two months.
Category
Treatment - Drugs
2
Description
The herbal formulation will be prescribed one tablet orally per day to the intervention group for two months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology & Metabolism Research Institute,Tehran University of Medical Sciences
Full name of responsible person
Ensieh Nasli-Esfahani
Street address
Diabetes Research Center, Shahrivar St., North Kargar Avenue,
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran's National Elites Foundation (INEF)
Full name of responsible person
Masood Yonesian
Street address
Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Tehran University of Medical Sciences, 16th Azar St.,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran's National Elites Foundation (INEF)
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
Pharmaceutical Sciences Research Center
Full name of responsible person
Parisa Sarkhail
Position
Pharm D. and Ph.D in Pharmacognosy/Assistant Prof.
Other areas of specialty/work
Street address
Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, 16th Azar St.,
City
Tehran
Postal code
Phone
+98 21 6412 2326
Fax
Email
sarkhail@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pharmaceutical Sciences Research Center
Full name of responsible person
Parisa Sarkhail
Position
Ph. D. in Pharmacognosy/ Assistant Prof.
Other areas of specialty/work
Street address
Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, 16th Azar St.,
City
Tehran
Postal code
Phone
+98 21 6412 2326
Fax
Email
sarkhail@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pharmaceutical Sciences Research Center
Full name of responsible person
Parisa Sarkhail
Position
Ph. D. in Pharmacognosy/ Assistant Prof.
Other areas of specialty/work
Street address
Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, 16th Azar St.,
City
Tehran
Postal code
Phone
+98 21 6412 2326
Fax
Email
sarkhail@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)