Evaluation of the effects of chamomile infusion consumption on metabolic responses and renal function biomarkers in patients with type 2 diabetes with diabetic participants who do not receive this intervention .
This study was designed to evaluate the effects of chamomile flower infusion on serum lipids، blood glucose and kidney functions in patients with type 2 diabetes. In this clinical trial, 40 volunteers with type 2 diabetes (male and female) aged 30–70 years will randomly allocate in two groups: intervention or control group. The intervention group will consume chamomile herbal tea (10g/100 ml hot water) two times per day before meals (lunch and dinner) for 4 weeks. No intervention will be done in control group. Exclusion criteria will include insulin treatment, history of diseases including liver, kidney and cancer, following a specific diet, regular exercise and having allergy to chamomile plant. Fasting blood glucose, 2 hour postprandial blood glucose, total cholesterol, triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, creatinine and urea will evaluate at the baseline and at the end of the trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014120918329N2
Registration date:2015-07-26, 1394/05/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-26, 1394/05/04
Registrant information
Name
Fatemeh Kaseb
Name of organization / entity
Diabetes Research Center, Shahid Sadoughi University of medical sciences, Yazd, Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 3821 5197
Email address
fkaseb@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Diabetes Research Center, Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of chamomile infusion consumption on metabolic responses and renal function biomarkers in patients with type 2 diabetes with diabetic participants who do not receive this intervention .
Public title
Effect of chamomile infusion on blood glucose, lipid profile and serum kidney functions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with type 2 diabetic aged over the 30 years; not having a history of gastrointestinal, renal, hepatic and heart disorders or allergic reactions to chamomile plant; not being under insulin therapy.
Exclusion criteria: consuming less than 30 % of the packed chamomile; changing the dose of medicines within the last 6 months or during the intervention; following a specific diet and changing their physical activity.
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)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of medical sciences
Street address
Talare Honar Alley, Shahid Sadoughi Blvd.
City
Yazd
Postal code
Approval date
2014-08-17, 1393/05/26
Ethics committee reference number
پ/17/1/102014
Health conditions studied
1
Description of health condition studied
type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Fasting blood glucose
Timepoint
At the start of intervention and 4 weeks after the intervention
Method of measurement
Blood biochemical tests
2
Description
2hour postprandial blood glucose
Timepoint
At the start of intervention and 4 weeks after the intervention
Method of measurement
Blood biochemical tests
3
Description
Total cholesterol
Timepoint
At the start of intervention and 4 weeks after the intervention
Method of measurement
Blood biochemical tests
4
Description
Triglyceride
Timepoint
At the start of intervention and 4 weeks after the intervention
Method of measurement
Blood biochemical tests
5
Description
Low density lipoprotein
Timepoint
At the start of intervention and 4 weeks after the intervention
Method of measurement
Blood biochemical tests
6
Description
High density lipoprotein
Timepoint
At the start of intervention and 4 weeks after the intervention
Method of measurement
Blood biochemical tests
Secondary outcomes
1
Description
Creatinine
Timepoint
At the start of intervention and 4 weeks after the intervention
Method of measurement
Blood biochemical tests
2
Description
Urea
Timepoint
At the start of intervention and 4 weeks after the intervention
Method of measurement
Blood biochemical tests
Intervention groups
1
Description
Intervention group: This group will consume one cup of chamomile herbal tea (10 grams of chamomile flowers infuse for 10 min in 100 mL hot water without sugar) two times a day before meals (lunch and dinner) for 4 weeks. The chamomile flowers will procure from the local market of Yazd.
Category
Other
2
Description
Control group: No intervention will be done in this group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Research Center, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Zeinab Zare
Street address
Talare Honar Alley, Shahid Sadoughi Blvd.
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shahid Sadoughi University of medical sciences, Yazd, Iran
Full name of responsible person
Nasim Namiranian (The contact person of the vice chalentor for research)
Street address
Talare Honar Alley, Shahid Sadoughi Blvd.
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Shahid Sadoughi University of medical sciences, Yazd, Iran
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 Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Zeinab Yazdanpanah
Position
MSc student of Health Sciences in Nutrition
Other areas of specialty/work
Street address
Department of Health, Imam Reza Institute, Student Blvd, Imam Hossein Sq.
City
Yazd
Postal code
Phone
+98 35 3526 3237
Fax
Email
yazd456@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Shahid Sadughi University of Medical Sciences
Full name of responsible person
Fatemeh Kaseb
Position
PhD in Nutrition
Other areas of specialty/work
Street address
Department of paramedicine, Imam Reza Institute, Student Blvd, Imam Hossein Sq.
City
Yazd
Postal code
Phone
+98 35 3624 0696
Fax
Email
fkaseb@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Zeinab Yazdanpanah
Position
MSc student of Health Sciences in Nutrition
Other areas of specialty/work
Street address
Department of Health, Imam Reza Institute, Student Blvd, Imam Hossein Sq.
City
Yazd
Postal code
Phone
+98 35 3526 3237
Fax
Email
yazd456@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)