- -Determination and comparison the effects of hydroalcoholic herbal extract and placebo on blood glucose status (FBS, HbA1c) in patients with type 2 diabetes
-Determining and comparison the effects of hydroalcoholic herbal extract and placebo on lipid profile (TC, TG, LDL-C, HDL-C) in patients with type 2 diabetes
-Determining and comparing the effects of hydroalcoholic herbal extract and placebo on anthropometric indices (weight, body mass index, waist circumference, hip circumference) in patients with type 2 diabetes
Design
Triple-blinded randomized clinical trial
Settings and conduct
Patients with diabetes who referred to clinics affiliated to Tehran University of Medical Sciences and are treated with hydroalcoholic herbal extract. The extract and container intended for placebo will be exactly the same size and color as the hydroalcoholic herbal extract, and a dark container will be selected for the extract and placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diabetic patients
Exclusion criteria: Insulin or liraglutide injection - people under 20 and over 70 years - having chronic cardiovascular diseases, major depression, chronic liver and kidney disease, chronic thyroid disorders and malignancies including cancer - taking neuroleptics and Psychotropic, herbal medicines or herbs to control blood sugar over the past 6 months - Patients being treated with a special diet such as vegetarianism or a specific exercise program. People with food or seasonal allergies - Pregnant and lactating women
Intervention groups
Intervention group: Receiving hydroalcoholic herbal extract (3 times a day and 20 drops in a cup of lukewarm water, half an hour before meals)
Control group: placebo daily (3 times a day and 20 drops in a cup of lukewarm water, half an hour before meals)
Main outcome variables
Fasting blood glucose
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110314006065N2
Registration date:2021-10-13, 1400/07/21
Registration timing:registered_while_recruiting
Last update:2021-10-13, 1400/07/21
Update count:0
Registration date
2021-10-13, 1400/07/21
Registrant information
Name
Nazli Namazi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 9630
Email address
nazli.namazi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-09, 1400/07/17
Expected recruitment end date
2022-02-09, 1400/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of hydroalcoholic herbal extract on glycemic status and lipid profile in patients with type ۲ diabetes
Public title
Herbal extract & diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes mellitus
Age 30 to 70 years
Exclusion criteria:
Insulin or liraglutide injection
People under 30 and over 70
Chronic cardiovascular disease, major depression, chronic liver and kidney disease, chronic thyroid disorders and malignancies including cancer
Neuroleptics, medical Herbs or herbs to control blood sugar over the past 6 months
Patients being treated with a special diet such as vegetarian diets or a specific exercise program.
People with food or seasonal allergies
Pregnant and lactating women
Age
From 30 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible subject be selected with convenience sampling and be randomly assigned into 2 groups of 30 subjects as intervention or placebo with block sizes of 2 with proportion 1:1. A person from research team not involved in the recruitment and assignment of participants will generate allocation sequence using the web site of www.Randomization.com.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants will be randomly assigned to one of two groups: 1) receiving a hydro-alcoholic plant extract, 2) receiving a placebo, and will be examined for 8 weeks. The extract and container intended for placebo will be exactly the same size and color as the plant hydroalcoholic extract, and a dark container will be selected for the extract and placebo.A person from research team not involved in the recruitment and assigning participants generate allocation sequence using web site of www.Randomization.com.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Endocrinology & Metabolism Research Institute
Street address
Endocrinology & Metabolism Research Institute, Shariati Hospital, North Kargar Avenue
City
Tehran
Province
Tehran
Postal code
1411713137
Approval date
2021-07-07, 1400/04/16
Ethics committee reference number
IR.TUMS.EMRI.REC.1400.052
Health conditions studied
1
Description of health condition studied
Type 2 diebetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
fasting blood sugar
Timepoint
Baseline, after 8 weeks of the intervention (At the end of the intervention)
Method of measurement
Autoanalyzer
Secondary outcomes
1
Description
Total cholesterol
Timepoint
Baseline, after 8 weeks of the intervention (At the end of the intervention)
Method of measurement
Autoanalyzer
2
Description
low-density lipoprotein
Timepoint
Baseline, after 8 weeks of the intervention (At the end of the intervention)
Method of measurement
Autoanalyzer
3
Description
High-density lipoprotein
Timepoint
Baseline, after 8 weeks of the intervention (At the end of the intervention)
Method of measurement
Autoanalyzer
4
Description
triglyceride
Timepoint
Baseline, after 8 weeks of the intervention (At the end of the intervention)
Method of measurement
Autoanalyzer
5
Description
HbA1c
Timepoint
Baseline, after 8 weeks of the intervention (At the end of the intervention)
Method of measurement
Chromatography
Intervention groups
1
Description
Intervention group: Receiving hydroalcoholic herbal extract (3 times a day and 20 drops in a cup of lukewarm water, half an hour before meals) for 8 weeks.
Category
Treatment - Other
2
Description
Control group: placebo which is a mixture of water and permitted dietary color (3 times a day and 20 drops in a cup of lukewarm water, half an hour before meals) for 8 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology and Metabolism Research Institute
Full name of responsible person
Nazli Namazi
Street address
Endocrinology & Metabolism Research Institute, Shariati Hospital, North Kargar Avenue
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 21 8863 1298
Email
nazli.namazi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Akbar Fotuhi
Street address
Vice Chancellor of Research and Technology Tehran University of Medical Sciences, Ghods Street, Keshavarz Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 21 8863 1298
Email
nazli.namazi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Nazli Namazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Endocrinology & Metabolism Research Institute, Shariati Hospital, North Kargar Avenue
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 919 241 4658
Email
nazli.namazi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nazli Namazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Endocrinology & Metabolism Research Institute, Shariati Hospital, North Kargar Avenue
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 919 241 4658
Email
nazli.namazi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nazli Namazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Endocrinology & Metabolism Research Institute, Shariati Hospital, North Kargar Avenue
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 919 241 4658
Email
nazli.namazi@yahoo.com
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