Herbal combination effect of securigera securidaca, vaccinium arctostaphylos, citrullus colocynthis and coriandrium sativum on fasting blood sugar and triglyceride in pre-diabetic elderly the city of Bushehr in 2015
The purpose of the study: the effect of herbal compound of securigera securidaca, vaccinium arctostaphylos, citrullus colocynthis and coriandrium sativum on fasting blood sugar and triglyceride.
Pre-diabetic patients in Bushehr as if this combination herbal fasting blood sugar and triglyceride-lowering effects have as an alternative to oral medications and injections to reduce blood sugar and blood lipid in diabetic patients in health care used.
Inclusion criteria: age between 60-70 years old; fasting blood sugar 100-125 mg/dl؛ Triglyceride between 180-250 mg/dl. Exclusion criteria: history of high blood sugar and using blood fat-lowering drugs two weeks ago؛ active diseases of the cardiovascular system؛ liver diseases. The study is a randomized controlled clinical trial. Samples include 60 pre-diabetic elderly randomly into two groups of 30 test and divided control. The experimental group includes use of a medicinal herb combination (combination securigera securidaca, vaccinium arctostaphylos, citrullus colocynthis and coriandrium sativum ) over a period of one month at a rate of 500 mg in the control group using the placebo. To evaluate the effectiveness of the intervention, patients in both groups before and after the intervention of a blood sample to measure levels of fasting blood sugar and triglyceride levels are taken.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015080822466N2
Registration date:2015-11-13, 1394/08/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-13, 1394/08/22
Registrant information
Name
Shahnaz Pouladi
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 374 0061
Email address
sh.pooladi@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical Sciences and Health Services
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Herbal combination effect of securigera securidaca, vaccinium arctostaphylos, citrullus colocynthis and coriandrium sativum on fasting blood sugar and triglyceride in pre-diabetic elderly the city of Bushehr in 2015
Public title
Herbal combination effect of securigera securidaca, vaccinium arctostaphylos, citrullus colocynthis and coriandrium sativum on fasting blood sugarand triglyceride in pre-diabetic elderly the city of Bushehr in 2015
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 60-70 years old; fasting blood sugar 100-125 mg/dl؛ Triglyceride between 180-250 mg/dl.
Exclusion criteria: history of high blood sugar and using blood fat-lowering drugs two weeks ago؛ active diseases of the cardiovascular system؛ liver diseases.
Age
From 60 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bushehr University of Medical Sciences
Street address
Bushehr-Sbzabad
City
Bushehr
Postal code
Approval date
2015-10-19, 1394/07/27
Ethics committee reference number
bpums.rec.1394.24
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E10
ICD-10 code description
Diabetes Mellitus
Primary outcomes
1
Description
Fasting blood sugar
Timepoint
Before and after the intervention
Method of measurement
An experiment using the enzymatic method
2
Description
Triglyceride
Timepoint
Before and after the intervention
Method of measurement
An experiment using a metering method
Secondary outcomes
1
Description
Gastrointestinal Complications
Timepoint
A week after the intervention and at the end of intervention
Method of measurement
Using a questionnaire
Intervention groups
1
Description
Intervention group: Herbal combination effect of securigera securidaca, vaccinium arctostaphylos, citrullus colocynthis and coriandrium sativum,500 mg oral capsules,Twice a day for one month
Category
Treatment - Drugs
2
Description
Control group:Placebo,500 mg oral capsules,Twice a day for one month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehr Laboratory, Diabetes Center, 7 Tir polyclinic
Full name of responsible person
Zinat Shababi, Nursing Graduate Student
Street address
Bushehr-Sbzabad-Bushehr University of Medical Sciences
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Afshin Ostovar
Street address
Bushehr University of Medical Sciences, Sabzabad
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bushehr 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
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Shahnaz Pouladi
Position
Nursing Ph.D
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Sabzabad
City
Bushehr
Postal code
Phone
+98 77 3345 0178
Fax
Email
pouladi2008@yahoo.com; sh.pooladi@bpums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Shahnaz Pouladi
Position
Nursing Ph.D.
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Sabzabad
City
Busheh
Postal code
Phone
+98 77 3345 0178
Fax
Email
Pouladi2008@yahoo.com; sh.pooladi@bpums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Shahnaz Pouladi
Position
Nursing Ph.D
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Sabzabad
City
Bushehr
Postal code
Phone
+98 77 3345 0178
Fax
Email
Pouladi2008@yahoo.com; sh.pooladi@bpums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)