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Determination of Apium graveolens L. fruits effect on HbA1C, 2HPP & FBS in type 2 diabetic patients

Protocol summary

Summary
The study was performed as a double-blind clinical trial to examine the effect of Apium graveolens L on the blood glucose in type 2 diabetic patients who referred to the diabetic treatment research center of Yazd. 74 patients diagnosed with diabetes type 2 with the age range of 20-80 are randomly selected and categorized into two groups. The patients do not take insulin, non-conventional medical products, and medicines including Aspirin, Warfarin, Clopidogrel, diuretics and Thyroid drugs as well as they are not pregnant and lactating. In the main group, in addition to their standard treatment, FBS, 2HPP, and HbA1C are measured before they start taking the capsules. Then, if the patients do not need to take insulin and are satisfied to participate and also considering the number of their oral medicines and HbA1C, they are enrolled in the study. Subsequently, along with their standard treatment, the patients take three capsules containing celery fruits per day, half an hour before a meal, within three months. After three months, the blood tests are repeated and FBS, 2HPP, and HbA1C are measured again. In the control group, the same procedure is done using placebo containing cellulose. Finally, the results of the two groups are compared together.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014081718828N1
Registration date: 2017-03-05, 1395/12/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-03-05, 1395/12/15
Registrant information
Name
Alimohammad Ranjbar
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3419
Email address
amranjbar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor research and technology Yazd University of Medical Sciences and researchers
Expected recruitment start date
2017-02-03, 1395/11/15
Expected recruitment end date
2018-03-06, 1396/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of Apium graveolens L. fruits effect on HbA1C, 2HPP & FBS in type 2 diabetic patients
Public title
Determination of Apium graveolens L. fruits effect on diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with diabetes type 2; Patients within the age range 20-80; Patients with the ability to speak Persian; Patients satisfaction with entering the study Exclusion criteria: Taking insulin; Taking common non-medical products; Patients who cannot take celery fruit capsules for any given reason; Patients with diabetes type 1; Pregnant and breastfeeding women; Patients taking Aspirin, Warfarin, Clopidogrel; Patients receiving diuretics or thyroid treatment
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Science
Street address
Talar honar alley, Bahonar square, Yazd, Iran
City
Yazd
Postal code
Approval date
2016-07-16, 1395/04/26
Ethics committee reference number
IR.SSU.REC.1395.70

Health conditions studied

1

Description of health condition studied
type 2 diabete
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Hemoglobin A1c (HbA1c)
Timepoint
3 months after drug use
Method of measurement
Blood test

Secondary outcomes

1

Description
Fasting blood sugar (FBS)
Timepoint
3 months after drug use
Method of measurement
Blood Test

2

Description
2 hour Post Prandial (2hpp)
Timepoint
3 months after drug use
Method of measurement
Blood Test

Intervention groups

1

Description
The participants in control group receive three cellulose capsules per day, 30 min before every meal, for three months along with standard treatments.
Category
Treatment - Drugs

2

Description
The participants in intervention group receive three celery fruit capsules per day, 30 min before every meal, for three months along with standard treatments.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabete Research Center
Full name of responsible person
Masoud Rahmanian
Street address
Talar Honar alley, Bahonar square, Yazd, Iran
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Science
Full name of responsible person
Hooshang Mehrparvar
Street address
Bahonar Square, Yazd, Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Science
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
Yazd University of Medical Sciences
Full name of responsible person
Alimohamad Ranjbar Jamal abadi
Position
PhD
Other areas of specialty/work
Street address
Professor Hesabi Boolvar, Yazd, Iran
City
Yazd
Postal code
Phone
+98 132537089
Fax
Email
amranjbar@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Diabete Research Center
Full name of responsible person
Masoud Rahmanian
Position
Endocorinologist, Assistant Professor
Other areas of specialty/work
Street address
Talare Honar Alley, Bahonar Square, Yazd, Iran
City
Yazd
Postal code
8917693571
Phone
+98 35 3728 0215
Fax
Email
drmasoudrahmanian@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences of Yazd
Full name of responsible person
Negin Ghafar
Position
Student Doctor of Pharmacy
Other areas of specialty/work
Street address
Yazd, Iran
City
Yazd
Postal code
Phone
00
Fax
Email
ghaffar.negin@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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