Evaluation of the efficacy of viabet capsule as adjunctive therapy in the treatment of type 2 diabetes
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
The study will be conducted on patients referred to Ghaem Hospital in Mashhad. In this study, patients, treating physician, pharmacy student, and clinical pharmacist will be blinded to which patient receives the drug or placebo.
Participants/Inclusion and exclusion criteria
inclusion
Type 2 diabetes according to the 2019 ADA Guideline; Only take metformin tablets; BMI between 25 - 32
Exclusion
Pregnancy and lactation; Sensitivity to drug; Taking other diabetes; medications except metformin; taking drugs that affect blood sugar such as glucocorticoids; Other serious illnesses such as heart failure; Stomach or duodenal ulcer; Use of anticoagulants such as heparin
Intervention groups
Viabet 500mg capsule three times daily in the intervention group and placebo capsule; Contains all ingredients in capsule viabet except active ingredients three times a day for three months
Main outcome variables
weight; FBS and HbA1c; blood pressure; Fat and liver profile; creatinine and BUN; Possible side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191015045124N1
Registration date:2020-02-17, 1398/11/28
Registration timing:registered_while_recruiting
Last update:2020-02-17, 1398/11/28
Update count:0
Registration date
2020-02-17, 1398/11/28
Registrant information
Name
Omid Tanzifi roodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5423 1891
Email address
tasnifio931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-07, 1398/10/17
Expected recruitment end date
2020-05-18, 1399/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of viabet capsule, a herbal formulation, as an adjuvant treatment for diabetes mellitus type 2
Public title
Evaluation of viabet capsule, a herbal formulation, as an adjuvant treatment for diabetes mellitus type 2
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes according to the 2019 ADA Guideline
Only take metformin tablets
BMI between 25 - 32
Exclusion criteria:
Pregnancy and lactation
Sensitivity to drug
Taking other diabetes medications except metformin
taking drugs that affect blood sugar such as glucocorticoids
Other serious illnesses such as heart failure
Stomach or duodenal ulcer
Use of anticoagulants such as heparin
Age
From 40 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
With the help of a randomization list provided by randomization.com site, patients will receive code 1 or 2 and will be included in placebo or medication group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The viabet and placebo formulations will be packaged by the manufacturer in identical-looking bottle and delivered to medicine specialist. Patients who meet the inclusion criteria are selected by medicine specialist to be included in the study, randomly assigned to a drug or placebo group and given a bottle with A or B mark. Patients will be evaluated in the course of treatment by an medicine specialist and a pharmacy student. Data collection and analysis are performed by the pharmacy student and clinical pharmacist. All of them will be unaware that A or B is on medication or placebo until the end of the study and data analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
daneshgah street; Qureshi Building
City
mashhad
Province
Razavi Khorasan
Postal code
1394491388
Approval date
2019-10-02, 1398/07/10
Ethics committee reference number
IR.MUMS.REC.1398.192
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
Fasting blood sugar
Timepoint
Starting Study; One month later; Two months later; End of study
Method of measurement
Measurement of serum level in the laboratory
2
Description
Hemoglobin A1C
Timepoint
Starting Study; End of study
Method of measurement
Measurement of serum level in the laboratory
Secondary outcomes
1
Description
Serum creatinine
Timepoint
starting Study; End of study
Method of measurement
Measurement of serum level in the laboratory
2
Description
Blood Urea Nitrogen
Timepoint
starting Study; End of study
Method of measurement
Measurement of serum level in the laboratory
3
Description
Aspartate aminotransferase
Timepoint
starting Study; End of study
Method of measurement
Measurement of serum level in the laboratory
4
Description
Alanine aminotransferase
Timepoint
starting Study; End of study
Method of measurement
Measurement of serum level in the laboratory
5
Description
Triglyceride
Timepoint
starting Study; End of study
Method of measurement
Measurement of serum level in the laboratory
6
Description
Cholesterol
Timepoint
starting Study; End of study
Method of measurement
Measurement of serum level in the laboratory
7
Description
Low-density lipoprotein
Timepoint
starting Study; End of study
Method of measurement
Measurement of serum level in the laboratory
8
Description
High-density lipoprotein
Timepoint
starting Study; End of study
Method of measurement
Measurement of serum level in the laboratory
9
Description
Weight
Timepoint
Starting Study; One month later; Two months later; End of study
Method of measurement
by scale
10
Description
Blood pressure
Timepoint
Starting Study; One month later; Two months later; End of study
Method of measurement
By manometer
Intervention groups
1
Description
Intervention group: viabet 500 mg three times a day for 3 months
Category
Treatment - Drugs
2
Description
Control group: viabet placebo three times a day for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital of Mashhad University of Medical Sciences
Full name of responsible person
Sepideh Elyasi
Street address
Vakilabad Boulevard; Ferdowsi University; Faculty of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3180 1588
Email
elyasis@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vakilabad Boulevard; Ferdowsi University; Faculty of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3180 1337
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
50
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
2
Sponsor
Name of organization / entity
Pharmaceutical Company Essential Oil Dr Soleimani
Full name of responsible person
Ala Soleimani
Street address
Valiasr Aven.
City
Gorgan
Province
Golestan
Postal code
09117018040
Phone
+98 17 3233 9999
Email
giahessence@gmail.com
Web page address
https://www.giahessence.com/fa-IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pharmaceutical Company Essential Oil Dr Soleimani
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Omid Tanzifi Roodi
Position
دانشجوی دکتری عمومی داروسازی
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Vakilabad Boulevard; Ferdowsi University; Faculty of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3180 1588
Email
tasnifio9331@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sepideh Elyasi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Vakilabad Boulevard; Ferdowsi University; Faculty of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3180 1588
Email
elyasis@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Omid tanzifi roodi
Position
دانشجوی دکتری عمومی داروسازی
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Vakilabad Boulevard; Ferdowsi University; Faculty of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
17871 91886
Phone
+98 51 3180 1588
Email
tasnifio931@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The information will be published as an article
When the data will become available and for how long
The article will be available through Infinite Journal
To whom data/document is available
Anyone who needs them can access
Under which criteria data/document could be used
The data not published in this article will be provided in coordination with all project partners and research assistants of Mashhad University of Medical Sciences
From where data/document is obtainable
Send an Email to Scientific Officer
What processes are involved for a request to access data/document
The consent of all research associates of Mashhad University of Medical Sciences should be obtained