This cross-over, double-blind study investigated the effect of decoction leaves fig tree on controlling type 2 diabetes. In this study 28 patients with type 2 diabetic were randomly assigned into two groups, 21-day study in two phases between these phases is interrupted for a week (rest period) is done be. At the first phase, the intervention group received decoction fig leaf and the control group received green tea and vice versa in the second phase. Blood glucose, glucose blood after fasting, Fructosamine, glycated hemoglobin, peptides c, SGOT and SGPT are measured at the beginning and the end of Phase I and Phase II of the rate parameters.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901123611N1
Registration date:2010-12-01, 1389/09/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-12-01, 1389/09/10
Registrant information
Name
Sadegh Ahmadi Mazhin
Name of organization / entity
Ahvaz Jundishapour University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 8223
Email address
sadeghahmadi2009@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2010-09-20, 1389/06/29
Expected recruitment end date
2010-11-08, 1389/08/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of fig leaf decoction on control of type 2 diabetes
Public title
The effect of fig leaf decoction on control of blood sugar in type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of type 2 diabetes, willing to participate to study, age 40-60 years, HbA1c between 7-8.5, usual daily activity,
Exclusion criteria: presence of any chronic diseases or any other diseases affecting the trial, inability to participate, any change in diet or exercise program, consumption of any affecting blood sugar, change in daily activity, any change in treatment plan, any change in mental condition
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University Of Medical sciences
Street address
University Square., Golestan Ave,
City
Ahvaz
Postal code
61537-15794
Approval date
2010-07-03, 1389/04/12
Ethics committee reference number
پ/8/20/د/1093
Health conditions studied
1
Description of health condition studied
Diabetes type 2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
2hpp BS
Timepoint
Baseline and days 21 and 49
Method of measurement
blood biochimecal test
2
Description
fructosamine
Timepoint
Baseline and days 21 and 49
Method of measurement
blood biochimecal test
3
Description
HbA1c
Timepoint
Baseline and days 21 and 49
Method of measurement
blood biochimecal test
4
Description
C peptide
Timepoint
Baseline and days 21 and 49
Method of measurement
blood biochimecal test
5
Description
SGOT
Timepoint
Baseline and days 21 and 49
Method of measurement
blood biochimecal test
6
Description
SGPT
Timepoint
Baseline and days 21 and 49
Method of measurement
blood biochimecal test
7
Description
FBS
Timepoint
Baseline and days 21 and 49
Method of measurement
blood biochimecal test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: fig leaf decoction, 13 gr, daily for 21 days
Category
Treatment - Drugs
2
Description
Control group: green tea, 13 g, daily, for 21 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic Of Golestan Hospital
Full name of responsible person
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy, Ahvaz Jundishapur University Of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
University Square, Golestan Ave.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy, 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 Jundihapur University Of Medical Sciences
Full name of responsible person
Sadegh Ahmadi Mazhin
Position
M.s student
Other areas of specialty/work
Street address
Day St., Golestan ave.
City
Ahvaz
Postal code
Phone
+98 935 910 5446
Fax
Email
apspa@yahoo.comsadeghahmadi2009@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences
Full name of responsible person
Marzieh Asadizaker
Position
M.s on Nursing Education
Other areas of specialty/work
Street address
Faculty of Nursing, Ahvaz Jondishapur University Of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 916 615 9157
Fax
Email
marziehasadizaker@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Sadegh Ahmadi Mazhin
Position
Other areas of specialty/work
Street address
City
Ahvaz
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)