Effect of Trigonella foenum-graecum, Vaccinium arctostaphylos, Cichorium intybus, Urtica dioica and Curcuma longa extracts mixture on blood sugar control in type 2 diabetic patients
Effect of Fenugreek, Caucasian whortleberry, Cichorium, Nettle and Turmeric extracts mixture on type 2 diabetes
Design
This double-blind, phase 2 clinical trial is performed in 86 type II diabetic patients divided equally in herbal and placebo groups. The herbal drug and placebo with code A or B who no one except laboratory expert aware of its contents are prescribed to patients for 3 months.
Settings and conduct
The type 2 diabetic patients referring to Baghiatallah Hospital according to inclusion criteria randomly divided three groups. َAfter selection the patients are given any of herbal drug or placebo capsule boxes by nurse with an identification code of A or B which are recorded in the patient's medical records. Physician, nurse, patients, data collector and who evaluate the outcome are unaware of the drug and placebo group. Only laboratory expert knows the types of the groups. Patients are aware that they are either in the herbal drug or placebo groups, but they are not aware of the type of group they are in.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Type II diabetic patients; 40 to 60 years old; fasting blood glucose levels 130 to170 mg/dL; glycosylated hemoglobin 7.5 to 8.5%
Exclusion criteria: Patients with a diabetic foot ulcer, gangrene or any severe illness and who tend to change their exercise program or diet
Intervention groups
Intervention group: Patients in this group receive a 500 mg capsule of herbal drug once a day after breakfast.
Control group: Patients in this group receive a 500 mg capsule of placebo once a day after breakfast.
Main outcome variables
ّFasting blood glucose and glycosylated hemoglobin levels are determined at baseline and after three months as a main outcome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001157N14
Registration date:2018-12-12, 1397/09/21
Registration timing:prospective
Last update:2018-12-12, 1397/09/21
Update count:0
Registration date
2018-12-12, 1397/09/21
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
Expected recruitment start date
2019-01-19, 1397/10/29
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Trigonella foenum-graecum, Vaccinium arctostaphylos, Cichorium intybus, Urtica dioica and Curcuma longa extracts mixture on blood sugar control in type 2 diabetic patients
Public title
Effect of Fenugreek, Caucasian whortleberry, Cichorium, Nettle and Turmeric extracts mixture on type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild to moderate type 2 diabetes
40 to 60 years old
Have diabetes for at least two years
Under treatment with a maximum daily dose of 1000 mg metformin and 10 mg glibenclamide
Fasting blood glucose levels between 130 to 170 mg/dL
Glycosylated hemoglobin between 7.5 to 8.5%
Exclusion criteria:
Patients with diabetic foot ulcer, gangrene, or any severe illness
Painful diabetic neuropathy and depressed patients
Smokers and alcoholic patients
Patients who tend to change their exercise program or diet
Age
From 40 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, a random number table and block randomization method is used. In this method the patients are assigned into blocks of 2 patients (total 43 blocks). Then, each of the 2 patients entered the block of herbal drug or placebo, with 43 patients assigned to each group. There is no significant difference in fasting blood glucose and glycosylated hemoglobin in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Package for herbal and placebo is labeled with code B or A. Other specifications on the labels are identical. Physicians, nurses, patients, data collectors and those who evaluate the outcome are unaware of the drug and placebo group. Only laboratory expert knows the types of the groups. Patients are aware that they are either in the herbal drug or placebo groups, but they are not aware of the type of group they are in.
Blood glucose level will be determined in laboratory by commercial standard kit
2
Description
Glycosylated hemoglobin
Timepoint
At starting of the study and after 3 months
Method of measurement
Glycosylated hemoglobin will be determined in laboratory by commercial standard kit
Secondary outcomes
1
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
2
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
3
Description
low-density lipoprotein
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood low-density lipoprotein level will be determined in laboratory by commercially available kit
4
Description
High-density lipoprotein
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood High-density lipoprotein level will be determined in laboratory by commercially available kit
5
Description
Aspartate aminotransferase
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood aspartate aminotransferase level will be determined in laboratory by commercially available kit
6
Description
Alanine aminotransferase
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood alanine aminotransferase level will be determined in laboratory by commercially available kit
7
Description
Blood urea nitrogen
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood blood urea nitrogen level will be determined in laboratory by commercially available kit
8
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
9
Description
Alkalin phosphatase
Timepoint
At starting of the study and after 3 months
Method of measurement
Blood Alkalin phosphatase level will be determined in laboratory by commercially available kit
Intervention groups
1
Description
Intervention group: Patients in this group receive a 500 mg capsule of herbal drug once a day after breakfast.The herbal drug capsule contains mixture of mentioned herbal extract powder and will be prepared in the pharmacognosy department of the Institute of Medicinal Plants, Jahad-e-daneshgahi.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group receive a 500 mg capsule of placebo once a day after breakfast.The placebo capsule contains toasted flour and will be prepared in the pharmacognosy department of the Institute of Medicinal Plants, Jahad-e-daneshgahi.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah University of Medical Sciences
Full name of responsible person
Reza Mohtashami
Street address
Vanak square, Molasadra Ave
City
Tehran
Province
Tehran
Postal code
1484958693
Phone
+98 21 8806 8923
Fax
+98 21 8806 8923
Email
rmohtashami@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Reza Hajiaghaee
Street address
Institute of Medicinal Plants, Kavosh Blvd., Supa Blvd., Poleh Kordan
City
karaj
Province
Alborz
Postal code
3365166571
Phone
+98 26 3476 4010
Fax
+98 26 3476 4021
Email
rhajiaghaee@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Fallah Huseini Hasan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Institute of Medicinal Plants, Kavosh Blvd., Supa Blvd., Poleh Kordan
City
Karaj
Province
Alborz
Postal code
3365166571
Phone
+98 26 3476 4010
Fax
+98 26 3476 4021
Email
h.fallah@acecr.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Hasan Fallah Huseini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Institute of Medicinal Plants, Kavosh Blvd., Supa Blvd., Poleh Kordan
City
Karaj
Province
Alborz
Postal code
3365166571
Phone
+98 26 3476 4010
Fax
+98 26 3476 4021
Email
h.fallah@acecr.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Hasan Fallah Huseini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Institute of Medicinal Plants, Kavosh Blvd., Supa Blvd., Poleh Kordan
City
Karaj
Province
Alborz
Postal code
3365166571
Phone
+98 26 3476 4010
Fax
+98 26 3476 4021
Email
h.fallah@acecr.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available