80 type II diabetic patients aged between 30 to 60 years, with fasting blood glucose between 150-220 mg/dl and HbA1c 7.5-10% taking two metformin 500 mg or two glibenclamid 5 mg tablets daily, with minimum two year history of diabetes that not changed antidiabetic regimen before 3 months were selected. The patients signed the written informed consent and randomly allocated into C. colocynthis and placebo group. The patients will continue their standard anti-diabetic therapy without any change during the study. The patients in C. colocynthis group were treated by C. colocynthis capsules of 100 mg 3 times a day and other group with placebo capsule in same manner for 4 month. At end of the study the fasting blood glucose, glycosylated haemoglobin, cholesterol, LDL, HDL, triglyceride, aspartate aminotransferase, alanine aminotransferase and creatinine levels were measured in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013010211984N1
Registration date:2014-07-03, 1393/04/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-03, 1393/04/12
Registrant information
Name
Maryam Yaghoobi
Name of organization / entity
Zahedan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 341 3296
Email address
yaghoobi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University Of Medical Sciences and
Institute of Medicinal Plants, ACECR, Karaj, Iran
Expected recruitment start date
2012-12-26, 1391/10/06
Expected recruitment end date
2013-06-20, 1392/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of citrullus colocynthis fruit extract on blood sugar in type II diabetic patients: a double blind clinical trial
Public title
Effect of citrullus colocynthis on Type II diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 30 to 60 years; fasting blood glucose between 180-220 mg/dl; HbA1c 7.5-9%; taking two metformin 500 mg or two glibenclamid 5 mg tablets daily; with minimum two year history of diabetes that not changed antidiabetic regimen before 3 months.
Exclusion criteria:Insulin therapy; severe kidney, liver, cardiovascular and infectious disease; pregnant and breast feeding woman.
Age
From 30 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ethic committee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences, Daneshgah Ave. Dr. Hesabi square,
City
Zahedan
Postal code
16743463
Approval date
2012-12-04, 1391/09/14
Ethics committee reference number
1432
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
Blood sugar
Timepoint
At baseline and after four months
Method of measurement
Fasting blood glucose was measured by commercial kit in laboratory
2
Description
Glycosylated haemoglobin
Timepoint
At baseline and after four months
Method of measurement
Blood HbA1C was determined in laboratory by commercially available kit
Secondary outcomes
1
Description
LDL
Timepoint
At baseline and after four months
Method of measurement
Blood LDL level was determined in laboratory by commercially available kit
2
Description
HDL
Timepoint
At baseline and after four months
Method of measurement
Blood HDL level was determined in laboratory by commercially available kit
3
Description
Cholesterol
Timepoint
At baseline and after four months
Method of measurement
Blood cholesterol level was determined in laboratory by commercially available kit
4
Description
Triglyceride
Timepoint
At baseline and after four months
Method of measurement
Blood triglyceride level was determined in laboratory by commercially available kit
5
Description
AST (aspartate aminotransferase)
Timepoint
At baseline and after four months
Method of measurement
Blood AST level was determined in laboratory by commercially available kit
6
Description
ALT (alanine aminotransferase)
Timepoint
At baseline and after four months
Method of measurement
Blood ALT level was determined in laboratory by commercially available kit
7
Description
Creatinine
Timepoint
At baseline and after four months
Method of measurement
Blood creatinine level was determined in laboratory by commercially available kit
Intervention groups
1
Description
Citrullus colocynthis capsule 100mg/TDS for 4 months
Category
Treatment - Drugs
2
Description
Placebo capsule100mg/TDS for 4 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Asghar diabetic clinic
Full name of responsible person
Maryam Yaghoobi
Street address
Ali Asghar clinic, Azadi street
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan University of Medical Sciences
Full name of responsible person
Mahmodzadeh Saqeb Hamid Reza
Street address
Zahedan University of Medical Sciences, Daneshgah Ave. Dr. Hesabi square
City
Zahedan
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, Zahedan University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Vice chancellery for research, Institute of medicinal plants
Full name of responsible person
Reza Hajiaghaee
Street address
Jahad daneshgahi research society, Kavosh blvd, Tehran-Qazvin highway, Karaj, Iran.
City
Karaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellery for research, Institute of medicinal plants
Proportion provided by this source
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
Zahedan University of Medical Sciences
Full name of responsible person
Maryam Yaghoobi
Position
M.Sc.
Other areas of specialty/work
Street address
Dr. Hesabi square, Daneshgah Ave.
City
Zahedan
Postal code
16743463
Phone
+98 54 1244 2482
Fax
+98 915 244 2481
Email
yaghoobi@zaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Institute of Medicinal Plants
Full name of responsible person
Hasan Fallah Huseini
Position
Ph.D.
Other areas of specialty/work
Street address
Research Complex of Jahad Daneshgahi, ACECR, Kavosh Boulevard, Supa Boulevard, Karaj-Qazvin Highway
City
Karaj
Postal code
13601360
Phone
+98 26 3476 4010
Fax
+98 26 3476 4021
Email
huseini_fallh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Maryam Yaghoobi
Position
M.Sc.
Other areas of specialty/work
Street address
Nursing and midwifery collegue
City
Zahedan
Postal code
16743463
Phone
+98 54 1244 2482
Fax
+98 54 1244 2481
Email
yaghoobi@zaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)