This project aims to investigate the effect of Olibanum Gum, Silybum marianum seed and Urtica dioica leaf extract mixture on fasting blood glucose and glycosylated hemoglobin in patients with type 2 diabetes. Total 60 type 2 diabetic patients aged 40 to 60 years with fasting serum glucose levels of 150 to 180 mg/dL and glycosylated hemoglobin of 7.5 to 8.5 percent, referring to Diabetic Clinic in Baghiyatallah Hospital will be randomly and equally selected into herbal drug and placebo groups. Herbal drug is mixture of Olibanum Gum, Silybum marianum seed and Urtica dioica leaf extracts and placebo is prepared using toast powder. The patients in herbal group will be taken a Herbal drug capsule three times daily for 3 months and placebo group will be taken placebo capsule in the same manner. The patient antidiabetic drugs or other treatments will be continued and unchanged during the study. Before and at end of the study the blood biochemical tests, including fasting blood glucose and glycosylated hemoglobin are determined as primary outcomes and fasting blood triglycerides, cholesterol, low-density lipoprotein, high-density lipoprotein, aspartate aminotransferase, alanine aminotransferase, creatinine and blood urea nitrogen are determined as secondary outcomes. All data of herbal group are compared to placebo group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201502011157N9
Registration date:2015-03-06, 1393/12/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-03-06, 1393/12/15
Registrant information
Name
Hasan Fallah Huseini
Name of organization / entity
Institute of Medicinal Plants
Country
Iran (Islamic Republic of)
Phone
+98 26 3476 4010
Email address
fallah@imp.ac.ir
Recruitment status
Recruitment complete
Funding source
Institute of Medicinal Plants
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Olibanum Gum, Silybum marianum seed and Urtica dioica leaf mixture on type 2 diabetic patients
Public title
To investigate the effect of Olibanum Gum, Silybum marianum seed and Urtica dioica leaf extracts mixture on blood sugar and glycosylated hemoglobin in type 2 diabetic patients: a double blind, randomized, placebo controlled trial.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Type 2 diabetic patients; aged 40 to 60 years; fasting blood glucose levels from 150 to 180 mg/dL; blood glycosylated hemoglobin levels from 7.5 to 8.5 percent; under therapy of oral anti-hyperglycemic drugs maximum 10 mg glyburide and 1000 mg metformin daily. Exclusion criteria: Patients receiving insulin therapy; patients with cardiao vascular, renal, hepatic, hematological, hypothyroidism, vertigo and seizure diseases; patients with a history of gallstones or gall bladder surgery; patients under estrogen, steroid, beta-blocker and thiazide therapy; pregnant women; women planning for pregnancy and breast-feeding women.
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The study will not be conducted in the Ramazan month and Norooz days
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Avicenna Research Institute
Street address
Shariati AVE, Yakhchal street, Avicenna Research Institute Central Building
City
Tehran
Postal code
Approval date
2015-02-20, 1393/12/01
Ethics committee reference number
Under consideration
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E10, E14,
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Fasting blood glucose
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood glucose level will be determined in laboratory by commercially available kit
2
Description
Glycosylated hemoglobin (HbA1c)
Timepoint
At starting of the study and after 3 months
Method of measurement
HbA1c percent will be determined in laboratory by commercially available kit
Secondary outcomes
1
Description
Cholesterol
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood cholesterol level will be determined in laboratory by commercially available kit
2
Description
Triglyceride
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood triglyceride level will be determined in laboratory by commercially available kit
3
Description
High-density lipoprotein (HDL)
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood HDL level will be determined in laboratory by commercially available kit
4
Description
Aspartate aminotransferase (AST)
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood AST level will be determined in laboratory by commercially available kit
5
Description
Alanine aminotransferase (ALT)
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood ALT level will be determined in laboratory by commercially available kit
6
Description
Blood urea nitrogen (BUN)
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood BUN level will be determined in laboratory by commercially available kit
7
Description
Creatinine
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood creatinine level will be determined in laboratory by commercially available kit
8
Description
low-density lipoprotein (LDL)
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood LDL level will be determined in laboratory by commercially available kit
Intervention groups
1
Description
Herbal Drug: 600 mg 3 times a day after food
Category
Treatment - Drugs
2
Description
Placebo: 600 mg 3 times a day after food
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghiatallah Hospital
Full name of responsible person
Dr. Reza Mohtashami
Street address
Baghiatallah Medical College, Mollasadra Street, Vanak Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Institute of Medicinal Plants
Full name of responsible person
Reza Hajiaghaee
Street address
Research Complex of Jahad Daneshgahi, Kavosh Boulevard, Supa Boulevard, 55-kilometer of the Tehran-Qazvin Highway
City
Karaj
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, Institute of Medicinal Plants
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
Full name of responsible person
Hasan Fallah Huseini
Position
Ph.D. in Pharmacology
Other areas of specialty/work
Street address
Research Complex of Jahad Daneshgahi, Kavosh Boulevard, Supa Boulevard, 55-kilometer of the Tehran-Qazvin Highway
City
Karaj
Postal code
13601360
Phone
+98 263476401020
Fax
Email
huseini_fallah@yahoo.com
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. in pharmacology
Other areas of specialty/work
Street address
Research Complex of Jahad Daneshgahi, Kavosh Boulevard, Supa Boulevard, 55-kilometer of the Tehran-Qazvin Highway
City
Karaj
Postal code
13601360
Phone
+98 263476401020
Fax
Email
huseini_fallah@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Institute of Medicinal Plants
Full name of responsible person
Hasan Fallah Huseini
Position
Ph.D. in pharmacology
Other areas of specialty/work
Street address
Research Complex of Jahad Daneshgahi, Kavosh Boulevard, Supa Boulevard, 55-kilometer of the Tehran-Qazvin Highway
City
Karaj
Postal code
13601360
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)