Protocol summary

Summary
Objective: Study on effects of Cynara scolymus L. leaf extract in treatment of hypercholesterolemic type 2 diabetic patients. Study population: Hypercholesterolemic type 2 diabetic patients attending the diabetes clinic. Sample size: 60 patients. Inclusion criteria: Iranian male and female type 2 diabetic outpatients, patients aged 40 to 60 years, patients with fasting serum glucose levels from 150 mg/dl to 200 mg/dl, patients with blood HbA1c levels from 7% to 9% despite taking two 5 mg glyburide tablets and two 500 mg metformin tablets every day, patients using two 5 mg glyburide tablets and two 500 mg metformin tablets every day, patients with fasting serum LDL levels from 100 mg/dl to 150 mg/dl. Exclusion criteria: Patients taking other anti-hyperglycemic and anti-hyperlipidemic agents, patients receiving insulin, patients with cardiac, renal, hepatic, hematological diseases, hypothyroidism, tachycardia, vertigo and seizure, patients with a history of gallstones or gall bladder surgery, patients using estrogen, steroid, beta-blocker and thiazide, pregnant women, women planning pregnancy, breast-feeding women. Intervention: The artichoke leaf extract is administered to a group of about 30 patients at the dose of one 400 mg capsule every 8 hours for 2 months and one placebo capsule is administered to another group of about 30 patients every 8 hours for 2 months. At the end of the study, the blood levels of fasting glucose, 2 hours postprandial glucose, glycosylated hemoglobin, lipids, creatinine and hepatic enzymes of the patients in the drug group and the placebo group are determined and compared with each other.

General information

Acronym
SECSTHT2DP
IRCT registration information
IRCT registration number: IRCT201112252288N5
Registration date: 2011-12-31, 1390/10/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-12-31, 1390/10/10
Registrant information
Name
Saeed Kianbakht
Name of organization / entity
Iranian Academic Center for Education, Culture and Research Institute of Medicinal Plants
Country
Iran (Islamic Republic of)
Phone
+98 26147640109
Email address
kianbakht@imp.ac.ir
Recruitment status
Recruitment complete
Funding source
Institute of Medicinal Plants affiliated with ACECR
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study on effects of Cynara scolymus L. leaf extract in treatment of hypercholesterolemic type 2 diabetic patients
Public title
Study on effects of artichoke in treatment of hypercholesterolemic type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Iranian male and female type 2 diabetic outpatients, patients aged 40 to 60 years, patients with fasting serum glucose levels from 150 mg/dl to 200 mg/dl, patients with blood HbA1c levels from 7% to 9% despite taking two 5 mg glyburide tablets and two 500 mg metformin tablets every day, patients using two 5 mg glyburide tablets and two 500 mg metformin tablets every day, patients with fasting serum LDL levels from 100 mg/dl to 150 mg/dl. Exclusion criteria: Patients taking other anti-hyperglycemic and anti-hyperlipidemic agents, patients receiving insulin, patients with cardiac, renal, hepatic, hematological diseases, hypothyroidism, tachycardia, vertigo and seizure, patients with a history of gallstones or gall bladder surgery, patients using estrogen, steroid, beta-blocker and thiazide, pregnant women, women planning pregnancy, breast-feeding women.
Age
From 40 years old to 60 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
Avicenna Research Institute affiliated with ACECR
Street address
Shahid Beheshti University, Shahid Chamran Freeway
City
Tehran
Postal code
1117719615
Approval date
2010-09-16, 1389/06/25
Ethics committee reference number
67/22/978

Health conditions studied

1

Description of health condition studied
Diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Fasting glucose serum level
Timepoint
2 months
Method of measurement
Medical laboratory (kit)

2

Description
Glycosylated hemoglobin blood level
Timepoint
2 months
Method of measurement
Medical laboratory (kit)

3

Description
LDL serum level
Timepoint
2 months
Method of measurement
Medical laboratory (kit)

Secondary outcomes

1

Description
SGOT serum level
Timepoint
2 months
Method of measurement
Medical laboratory (kit)

2

Description
SGPT serum level
Timepoint
2 months
Method of measurement
Medical laboratory (kit)

3

Description
Total cholesterol serum level
Timepoint
2 months
Method of measurement
Medical laboratory (Kit)

4

Description
VLDL serum level
Timepoint
2 months
Method of measurement
Medical laboratory (kit)

5

Description
HDL serum level
Timepoint
2 months
Method of measurement
Medical laboratory (kit)

6

Description
Triglyceride serum level
Timepoint
2 months
Method of measurement
Medical laboratory (kit)

7

Description
Creatinine serum level
Timepoint
2 months
Method of measurement
Medical laboratory (kit)

8

Description
2 hours postprandial glucose serum level
Timepoint
2 months
Method of measurement
Medical laboratory (kit)

Intervention groups

1

Description
Artichoke leaf extract at the dose of one 400 mg capsule every 8 hours in addition to daily two 5 mg glyburide tablets and two 500 mg metformine tablets are adminstered to a group of about 30 patients for 2 months.
Category
Treatment - Drugs

2

Description
One placebo capsule every 8 hours in addition to daily two 5 mg glyburide tablets and two 500 mg metformine tablets are adminstered to a group of about 30 patients for 2 months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes clinic
Full name of responsible person
Dr. Behrouz Abasi Alaee
Street address
Number 448, Street Bareghan, Square Azadegan
City
Karaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jahade Daneshgahi
Full name of responsible person
Haji Tarverdi
Street address
Jahade Daneshgahi, Enghelab St.
City
Tehran
Grant name
48-1564
Grant code / Reference number
1564-48
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahade Daneshgahi
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
Institute of Medicinal Plants affiliated with the ACECR
Full name of responsible person
Dr. Saeed Kianbakht
Position
Ph.D. in pharmacology, assistant professor of the department of pharmacology and applied medicine in
Other areas of specialty/work
Street address
Institute of Medicinal Plants, Research Complex of the ACECR, End of Kavosh Boulevard, Kavosh Research Town, 55th Kilometer of Tehran-Gazvin Freeway
City
Karaj
Postal code
2378965473
Phone
+98 26147640109
Fax
+98 26 1476 4021
Email
kianbakht@imp.ac.ir; skianbakht@gmail.com
Web page address
www.imp.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Institute of Medicinal Plants affiliated with the ACECR
Full name of responsible person
Dr. Saeed Kianbakht
Position
Ph.D. in pharmacology, assistant professor of the department of pharmacology and applied medicine in
Other areas of specialty/work
Street address
Institute of Medicinal Plants, Research Complex of the ACECR, End of Kavosh Boulevard, Kavosh Research Town, 55th Kilometer of Tehran-Gazvin Freeway
City
Karaj
Postal code
2378965473
Phone
+98 26147640109
Fax
+98 26 1476 4021
Email
kianbakht@imp.ac.ir; skianbakht@gmail.com
Web page address
www.imp.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Institute of Medicinal Plants affiliated with the ACECR
Full name of responsible person
Dr. Saeed Kianbakht
Position
Ph.D. in pharmacology, assistant professor of the department of pharmacology and applied medicine in
Other areas of specialty/work
Street address
Institute of Medicinal Plants, Research Complex of the ACECR, End of Kavosh Boulevard, Kavosh Research Town, 55th Kilometer of Tehran-Gazvin Freeway
City
Karaj
Postal code
2378965473
Phone
+98 26147640109
Fax
+98 26 1476 4021
Email
kianbakht@imp.ac.ir; skianbakht@gmail.com
Web page address
www.imp.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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