The objective of this study is to investigate the effects of Tribulus terrestris (TT) extract on blood glucose and lipid parameters in patients with type 2 diabetes mellitus.The study was carried out as a randomized double-blind, placebo controlled trial. Major inclusion criteria were not to use herbal remedies at least for a month before the study; not to be treated with hormonal compounds; to be controlled with oral hypoglycemic drugs; not to have any other chronic disease such as renal, hepatic or cardiovascular diseases, not to use vasodilators; negative family history of breast cancer; no diagnosed complication of diabetes or uncontrolled hypertension.
Through the study,100 diabetic women will be divided into two equal groups (drug and placebo). Blood samples for blood sugar and lipid levels will be get before and after the intervention. The relevant information will be collected and statistical analysis will be conducted.
The intervention group will receive 1 gram of TT extract divided in two doses for three consecutive months. In the control group, placebo will be given in similar amount and duration. Main outcome measures will be fasting blood glucose, 2 hours postprandial glucose, glycated hemoglobin, triglycerides, total cholesterol, low density lipoprotein and high density lipoprotein
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062922971N1
Registration date:2015-12-02, 1394/09/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-02, 1394/09/11
Registrant information
Name
Nasrin Babadaei Samani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1111 1111
Email address
babadaei@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2014-12-20, 1393/09/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Tribulus terrestris hydroalcoholic extract on blood glucose and lipids profile in 40 to 60 years old women with Diabetes Type II
Public title
Effect of Tribulus terrestris extract on blood glucose and lipids profile
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: Willingness to cooperate and participate in the study; give written informed consent by the patient; not to use herbal remedies at least for a month before the study; not to be treated with hormonal compounds; to be controlled with oral hypoglycemic drugs; not to have any other chronic disease such as renal, hepatic or cardiovascular diseases, not to use vasodilators; negative family history of breast cancer; no diagnosed complication of diabetes or uncontrolled hypertension.
Exclusion criteria: insulin therapy; non-compliance to the study protocol; Any sensitivity to TT or unusual drug side effects.
Age
From 40 years old to 60 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
randomization using permutation block
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences, Zand street, Shiraz
City
Shiraz
Postal code
71345-1978
Approval date
2014-11-05, 1393/08/14
Ethics committee reference number
9378-7208
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
HbA1c
Timepoint
Before the intervention, three months after intervention
Method of measurement
According mg/dl using lab kit
2
Description
FBS
Timepoint
Before the intervention, three months after intervention
Method of measurement
According mg/dl using lab kit
3
Description
TG
Timepoint
Before the intervention, three months after intervention
Method of measurement
According mg/dl using lab kit
4
Description
Cholesterol
Timepoint
Before the intervention, three months after intervention
Method of measurement
According mg/dl using lab kit
5
Description
HDL
Timepoint
Before the intervention, three months after intervention
Method of measurement
According mg/dl using lab kit
6
Description
LDL
Timepoint
Before the intervention, three months after intervention
Method of measurement
According mg/dl using lab kit
7
Description
2hpp
Timepoint
Before the intervention, three months after intervention
Method of measurement
According mg/dl using lab kit
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: Tribulus Terrestris, capsules 500 mg twice daily for three months.
Category
Treatment - Drugs
2
Description
control group: Cellulose, 500 mg, twice daily for three months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Shahid Motahari clinic
Full name of responsible person
Nasrin Babadaei Samani
Street address
next to Namazi Hospital, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Dr Seyed Basir Hashemi
Street address
Central Building of University of Medical Sciences, Zand Ave, Shiraz.
City
Shiraz
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 of Shiraz 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
Shiraz Medical Science University
Full name of responsible person
Nasrin Babadaei Samani
Position
Master of Science
Other areas of specialty/work
Street address
Central Building of University of Medical Sciences, Zand street, Shiraz
City
Shiraz
Postal code
00
Phone
00
Fax
Email
samani_nasrin@yahoo.com; babadaei@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz Medical Science University
Full name of responsible person
Azam Jokar
Position
master of science
Other areas of specialty/work
Street address
Central Building of University of Medical Sciences, Zand Ave, Shiraz