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Investigating the effect of a supplement of hydroalcoholic extract of Eryngium on the metabolic marker in type 2 diabetic patients

Protocol summary

Study aim
Determination of the effect of a supplement of hydro-alcoholic extract of Eryngium on the metabolic marker in type 2 diabetic patients
Design
The clinical trial with two groups (intervention and control), pragmatic, double-blind, randomized
Settings and conduct
This study was conducted to evaluate the effect of hydroalcoholic extract of Eryngium on the metabolic marker in type 2 diabetic patients in the Diabetes Clinic of Sabzevar University of Medical Sciences.Clinical observant and participants will be unaware of how they are grouped. Patients will be randomized in the intervention group (hydroalcoholic extract of Eryngium) and in the control (placebo). The response to treatment is evaluated by metabolic markers at the end of the third month after the intervention for both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Type 2 diabetes for at least 2 years, HbA1C less than 8.5, Patients aged 20-60 years, Non-insulin treated diabetic patients. Exclusion criteria: Pregnancy and breastfeeding, Renal and cardiovascular disorders and chronic underlying disease, Insulin therapy, Micro and macro-vascular diabetic complications, Use of other herbal medicines that have an effect on diabetes, Smoking or alcohol abuse within a month before the study
Intervention groups
Intervention group: Patients in this group are treated with Hydroalcoholic extract of Eryngium (10 drops 3 times a day) for 3 months. (Each ml (28 drops) of this drug contains 924 mg of dry Eryngium). Control group: Patients in this group are treated with placebo (10 drops 3 times a day) for 3 months.
Main outcome variables
Determination of FBS, HbA1C, Triglyceride, cholesterol, LDL, HDL, creatinine, urea, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase levels

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181006041252N7
Registration date: 2019-01-25, 1397/11/05
Registration timing: registered_while_recruiting

Last update: 2019-01-25, 1397/11/05
Update count: 0
Registration date
2019-01-25, 1397/11/05
Registrant information
Name
Mohammad Sahebkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 8337
Email address
sahebkarm@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of a supplement of hydroalcoholic extract of Eryngium on the metabolic marker in type 2 diabetic patients
Public title
Investigating the effect of a supplement of hydroalcoholic extract of Eryngium on the metabolic marker in type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes for at least 2 years HbA1C less than 8.5 Patients aged 20-60 years Non-insulin treated diabetic patients
Exclusion criteria:
Pregnancy and breastfeeding Renal and cardiovascular disorders and chronic underlying disease Insulin therapy Micro and macro-vascular diabetic complications Use of other herbal medicines that have an effect on diabetes Smoking or alcohol abuse within a month before the study.
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was conducted based on a permutation block, Accordingly, 42 blocks were allocated to patients, in each block, 2 were from following groups, treatment group A and group B. Eventually, after completing the blocks, Group A and B were treated with hydroalcoholic extract of Eryngium and Placebo tablet, respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
Each person will be assigned a study code A and B, which will only be known to the researcher of the type of groups. The clinical observant and the participants are unaware of the groups. It should be noted that hydroalcoholic extract of Eryngium and placebo have been similar in appearance, color, and packaging.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences, Tohid Blvd, Sabzevar city
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2019-01-19, 1397/10/29
Ethics committee reference number
IR.MEDSAB.REC.1397.099

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
Determine Fasting Blood Sugar (FBS)
Timepoint
At the beginning of the study (before the intervention) and 3 months after starting the intervention
Method of measurement
Use of Auto-Analyzer machine and Spectrophotometric method

2

Description
Determination level of Glycosylated Hemoglobin (HbA1C)
Timepoint
At the beginning of the study (before the intervention) and 3 months after starting the intervention
Method of measurement
Use of Auto-Analyzer machine and Spectrophotometric method

3

Description
Determination level of Triglyceride
Timepoint
At the beginning of the study (before the intervention) and 3 months after starting the intervention
Method of measurement
Use of Auto-Analyzer machine and Spectrophotometric method

4

Description
Determination level of Cholesterol
Timepoint
At the beginning of the study (before the intervention) and 3 months after starting the intervention
Method of measurement
Use of Auto-Analyzer machine and Spectrophotometric method

5

Description
Determination level of Low-density Lipoprotein (LDL)
Timepoint
At the beginning of the study (before the intervention) and 3 months after starting the intervention
Method of measurement
Use of Auto-Analyzer machine and Spectrophotometric method

6

Description
Determination level of High-density Lipoprotein (HDL)
Timepoint
At the beginning of the study (before the intervention) and 3 months after starting the intervention
Method of measurement
Use of Auto-Analyzer machine and Spectrophotometric method

7

Description
Determination level of Creatinine
Timepoint
At the beginning of the study (before the intervention) and 3 months after starting the intervention
Method of measurement
Use of Auto-Analyzer machine and Spectrophotometric method

8

Description
Determination level of Urea
Timepoint
At the beginning of the study (before the intervention) and 3 months after starting the intervention
Method of measurement
Use of Auto-Analyzer machine and Spectrophotometric method

9

Description
Determination level of Alkaline Phosphatase
Timepoint
At the beginning of the study (before the intervention) and 3 months after starting the intervention
Method of measurement
Use of Auto-Analyzer machine and Spectrophotometric method

10

Description
Determination level of Aspartate Aminotransferase (AST) (SGOT)
Timepoint
At the beginning of the study (before the intervention) and 3 months after starting the intervention
Method of measurement
Use of Auto-Analyzer machine and Spectrophotometric method

11

Description
Determination level of Alanine Aminotransferase (ALT) (SGPT)
Timepoint
At the beginning of the study (before the intervention) and 3 months after starting the intervention
Method of measurement
Use of Auto-Analyzer machine and Spectrophotometric method

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in this group are treated with Hydroalcoholic extract of Eryngium (10 drops 3 times a day) for 3 months. (Each ml (28 drops) of this drug contains 924 mg of dry Eryngium)
Category
Treatment - Drugs

2

Description
Control group: Patients in this group are treated with placebo (10 drops 3 times a day) for 3 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Clinic of Sabzevar University of Medical Sciences
Full name of responsible person
Maede Salehabadi
Street address
Vasei Hospital, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1014
Email
maede.salehabadi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Fereshte Ghorat
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8319
Email
Drghorat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Fereshte Ghorat
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8337
Email
Drghorat@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Fereshte Ghorat
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8337
Email
Drghorat@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Maede Salehabadi
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8337
Email
maede.salehabadi@gmail.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
Not applicable
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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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