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Diabetes Explanation & Evaluation the Effect of Ziabitos capsule consumption on Blood Glucose Control, in Patients with Type 2 Diabetes, in Traditional Iranian medicine.

Protocol summary

Summary
The study is a clinical trial of patients (Before & After Study). the aim of clarifying the effect of Ziabitos capsule consumption on Blood Glucose Control, in Patients with Type 2 Diabetes. In this study, 40 patients referred to the endocrine clinic and laboratories in martyr Mostafa Khomeini hospital and shahed traditional medicine clinic With uncontrolled diabetes (HbA1c> 7%) and treated with oral diabetes medications (one or more Pharmaceutical group) are being studied. study period in this study is Four-week.Ziabitos capsule consumption is three times daily, immediately before the meal and the dose of each capsules is 500 mg (1500 mg in day). At the beginning and end of study for all patients; Cr, BUN, Na, K, SGPT, SGOT, TG, CHOL, FRUCTOSAMINE, BS (2hpp), FBS, CBC,serum Alb, HbA1c (in beginning of study) and GFR levels are measured.before and after quantitative variables are compared with paired Studen's t test.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201108107286N1
Registration date: 2011-11-06, 1390/08/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-11-06, 1390/08/15
Registrant information
Name
Majid Asghari
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 5527 7400
Email address
asghari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed university
Expected recruitment start date
2011-10-12, 1390/07/20
Expected recruitment end date
2011-12-06, 1390/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Diabetes Explanation & Evaluation the Effect of Ziabitos capsule consumption on Blood Glucose Control, in Patients with Type 2 Diabetes, in Traditional Iranian medicine.
Public title
Ziabitos capsule effect on blood glucose control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- Age: 30 – 70 years 2- Uncontrolled Type 2 Diabetes: (HbA1c >7%) 3- Treated with oral diabetes medications (one or more Pharmaceutical group) 4- Over at least a month, since the addition of anti-diabetic drug dosage or prescribe a new anti-diabetic drug ٍExclusion criteria: 1- GFR (Glomerular Filtration Rate) < 60 ml/mi 2- Serum Alb < 4 gr/dl 3 - High SGOT and SGPT: more than three times the normal
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahed University
Street address
Shahed university, Opposite the Shrine of Imam Khomeini, Freeway at Tehran - Qom, Tehran.
City
Tehran
Postal code
3319118751
Approval date
2011-05-31, 1390/03/10
Ethics committee reference number
4/112251

Health conditions studied

1

Description of health condition studied
Diabet
ICD-10 code
E10-E14
ICD-10 code description
Diabetes Mellitus

Primary outcomes

1

Description
2h postparandial blood suger
Timepoint
Before and four weeks after Intervention
Method of measurement
Mg per deciliter and a lab kit

2

Description
Serum Fructosamine
Timepoint
Before and four weeks after Intervention
Method of measurement
Micromol per liter and a lab kit

3

Description
Fasting Blood Sugar
Timepoint
Before and four weeks after Intervention
Method of measurement
Mg per deciliter and a lab kit

Secondary outcomes

1

Description
Triglycerid
Timepoint
Before and four weeks after Intervention
Method of measurement
Mg per deciliter and a lab kit

2

Description
Total cholestrol
Timepoint
Before and four weeks after Intervention
Method of measurement
Mg per deciliter and a lab kit

3

Description
Aspartat Aminotransferase
Timepoint
Before and four weeks after Intervention
Method of measurement
unit per liter and a lab kit

4

Description
Blood Urea Nitrogen
Timepoint
Before and four weeks after Intervention
Method of measurement
Meq per liter and a lab kit

5

Description
Cratinin
Timepoint
Before and four weeks after Intervention
Method of measurement
Meq per liter and a lab kit

6

Description
Alanin Aminotransferase
Timepoint
Before and four weeks after Intervention
Method of measurement
unit per liter and a lab kit

7

Description
Sodium (Na)
Timepoint
Before and four weeks after Intervention
Method of measurement
Meq per liter and a lab kit

8

Description
Potasium(K)
Timepoint
Before and four weeks after Intervention
Method of measurement
Meq per liter and a lab kit

9

Description
Serum Albumin
Timepoint
Before and four weeks after Intervention
Method of measurement
gr per deciliter and a lab kit

10

Description
Glumerolar Filteration Rate (GFR)
Timepoint
Before and four weeks after Intervention
Method of measurement
Ml Per Min And Glomerular filtration rate calculated using the formula

11

Description
Complit Blood Count (CBC)
Timepoint
Before and four weeks after Intervention
Method of measurement
Based on the number And Lab kit

12

Description
Hemoglobin A1c Glycosilate (HbA1c)
Timepoint
Before of Intervention(in beginning of study)
Method of measurement
per cent and a lab kit

Intervention groups

1

Description
Ziabitos, 500 mg oral capsule, three times daily, for four weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Martyr Mostafa Khomeini Hospital and Shahed Traditional medicine clinic
Full name of responsible person
Majid Asghari
Street address
Martyr Mostafa Khomeini Hospital And Salamat clinic, the streets of Italy, Tehran.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University Research
Full name of responsible person
Mohsen Naseri
Street address
Salamat clinic, next to martyr Mostafa Khomeini hospital, Italy street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University Research
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
Shahed University
Full name of responsible person
Majid Asghari
Position
Assistant Phd doctorate in traditional medicine in Iran
Other areas of specialty/work
Street address
Salamat clinic, next to martyr Mostafa Khomeini Hospital, the streets of Italy, Tehran
City
Tehran
Postal code
14166
Phone
+98 21 8895 4412
Fax
+98 21 8896 7573
Email
Asghari@Razi.Tums.ac.ir Asghari@Shahed.ac.ir
Web page address
www.shahed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
shahed university
Full name of responsible person
Majid Asghari
Position
Phd Condidate in Traditional Medicine in Iran
Other areas of specialty/work
Street address
Salamat clinic, next to martyr Mostafa Khomeini Hospital, the streets of Italy, Tehran.
City
Tehran
Postal code
14166
Phone
+98 21 8895 4412
Fax
+98 21 8896 7573
Email
Asghari@Razi.Tums.ac.ir Asghari@Shahed.ac.ir
Web page address
www.shahed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Majid Asghari
Position
PhD Candidate in Traditional Medicine in Iran
Other areas of specialty/work
Street address
Salamat clinic, Next to martyr Mostafa Khomeini Hospital, Italy st., Tehran
City
Tehran
Postal code
14166
Phone
+98 21 8895 4412
Fax
+98 21 8896 7573
Email
asghari@Razi.Tums.ac.ir asghari@shahed.ac.ir
Web page address
WWW.shahed.ac.ir

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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