Protocol summary

Summary
Objectives: The effect of oral administration of Spirulina Platensis (cultured Iranian type) on the blood glucose and glycosylated Hemoglobin in type II diabetes mellitus patients. Design: the participants will be selected from male and female type 2 diabetics admitted to the Diabetes Research Center (with the range of 30 to 60 years old, and 5-10 years history of oral anti-diabetic therapy). After completing the relevant questionnaire, at least 50 cases (non-randomized) with fasting blood glucose between 126-300 mgr/dl and HbA1c >7 mgr/ dl will be selected. However, smokers, patients with underlying diseases as well as pregnant and breastfeeding women will be excluded from the study. Setting and Intervention: The patients will be divided into two groups: a control group (only receiving oral anti-diabetic medications) and a treatment group who will receive Spirulina platensis powder concentrate 8 grams per day (In three divided doses every 8 hours) in addition to their previous treatment. These patients will be monitored for 90 days. Main Outcome Measures: The patients’ blood glucose level will be measured (after 12 hours fasting) at 0, 30, 60 and 90 days after the intervention; their HbA1c levels will be recorded both at the beginning and at the end of study.

General information

Acronym
-------------------
IRCT registration information
IRCT registration number: IRCT2016052528067N1
Registration date: 2016-08-22, 1395/06/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-08-22, 1395/06/01
Registrant information
Name
Hamideh Ghodrati azadi
Name of organization / entity
Ferdowsi University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3880 5631
Email address
ghodrati@um.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancelator for research of Ferdowsi University of Mashhad - Nano chemical cell company (Manufacturer and provider of Spirulina platensis powder)
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of oral administration of Spirulina Platensis (cultured Iranian) on blood glucose and glycosylated Hemoglobin blood in type II diabetes mellitus patients
Public title
Effect of Spirulina in the treatment of Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The age range of 30-60 years old; Type II Diabetic patients ; Disease duration 5-10 years ; Fasting blood glucose 126-300 milligram per deciliter ; Hemoglobin A1c more than 7 Exclusion criteria: Smoking; Develop other underlying medical condition ; Pregnancy and Breastfeeding
Age
From 30 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is performed on patients of 10 diabetes centers in Mashhad by Non-random method .

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committees of Ferdowsi University of Mashhad and Mashhad University of Medical Sciences
Street address
pardis of Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Postal code
917751793
Approval date
2015-05-23, 1394/03/02
Ethics committee reference number
IR.MUMS.REC.1394.16

Health conditions studied

1

Description of health condition studied
Diabetes type2
ICD-10 code
IV
ICD-10 code description
E11

Primary outcomes

1

Description
Plasma glucose
Timepoint
0 and 30 days and 60 days and 90 days after intervention
Method of measurement
milligrams per deciliter by Autoanalyser

2

Description
Hemoglubin A1c
Timepoint
At 0 and 90 days after intervention
Method of measurement
milligrams per deciliter by NycoCard

Secondary outcomes

1

Description
Liver function tests
Timepoint
every 3 month
Method of measurement
Auto analyzer kits

Intervention groups

1

Description
Treatment group will receive Spirulina concentrate powder, product of Nano chemical cell company, at dose of 8 grams in 3 divided dose per day for 3 months in addition to their previous drugs.
Category
Treatment - Drugs

2

Description
Control group recieve their previous diabetes drugs.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid ghodsi health center in Mashhad
Full name of responsible person
Melika Beihaghi
Street address
Sanabad Street
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Ferdowsi University of Mashhad
Full name of responsible person
Hamideh Ghodrati Azadi
Street address
Faculty of Veterinary Medicine, Pardis of Ferdowsi University of Mashhad, Azadi square
City
Mashhad
Grant name
3
Grant code / Reference number
33219
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Ferdowsi University of Mashhad
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
Ferdowsi University of Mashhad
Full name of responsible person
Melika Beihaghi
Position
Master of Sciences
Other areas of specialty/work
Street address
Faculty of Veterinary Medicine, Ferdowsi University of Mashhad , Azadi square
City
Mashhhad
Postal code
9177948974
Phone
+98 985137629475
Fax
Email
melika.beihaghi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Hamideh Ghodrati Azadi
Position
Ph.D in Biochemistry
Other areas of specialty/work
Street address
Faculty of Veterinary Medicine, Ferdowsi University of Mashhad , Azadi square
City
Mashhad
Postal code
9177948974
Phone
+98 51 3880 5631
Fax
Email
ghodrati@um.ac.ir; hamidehga@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Melika Beihaghi
Position
Clinical biochemistry (MSc)
Other areas of specialty/work
Street address
Faculty of Veterinary Medicine, Ferdowsi University of Mashhad , Azadi square
City
Mashhad
Postal code
9177948974
Phone
+98 51 3762 9475
Fax
Email
melika.beihaghi@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
Loading...