Assessment and compression of the influence of traditional medicine based food regime and behavior on anthropometric indexes, blood tests, and mental health in adult fasting Muslims in Shiraz
The purpose of this study is a comparison between traditional medicine based food regime and behavior and a regular one in adult fasting Muslims at Ramadan in a selected population of Shiraz city. Finally, if traditional medicine based diet regime and behavior are more effective than a regular one on the mental and physical health of adult Muslims, we can recommend it to them and thus improve the quality of fasting and promote the spiritual and psychological well-being of the community. The main inclusion criteria are age and having physically affordable, and the main exclusion criteria are having critical underlying diseases, Pregnant and lactating mothers and having very low or high BMI. The study population included all fasting people in Shiraz during Ramadan. In this double-blind study, the participants will be randomly assigned into two groups of 100 people with computer software. Traditional medicine tips training will be done in Intervention group. So a booklet which published by Office of Traditional Medicine of the Ministry of Health of Iran will be given to this group. For the control group, Traditional medicine tips training and consultation will not be done.(No action) then two groups in three-time sections including before Ramadan, after Ramadan and three months after Ramadan will be assessed through anthropometric indexes, blood tests, and mental health.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017070434897N1
Registration date:2017-10-15, 1396/07/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-15, 1396/07/23
Registrant information
Name
Seyed Hossein Owji
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3624 7985
Email address
owji_h@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2017-05-23, 1396/03/02
Expected recruitment end date
2017-05-26, 1396/03/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment and compression of the influence of traditional medicine based food regime and behavior on anthropometric indexes, blood tests, and mental health in adult fasting Muslims in Shiraz
Public title
effect of the traditional medicine on health during fasting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Ages between 18 to 60 years which can afford fasting; People who tend to fast during Ramadan and this Ramadan is not their first fasting time.
Exclusion criteria:
having uncontrolled hypertension or malignant hypertension; having severe neurological disease (depression, schizophrenia, and addiction); having severe medical disease (diabetes, hyperlipidemia, cancer and rheumatologic disorder); Pregnant and lactating mothers; having swallowing problem, under therapeutic regime or having body mass index under 20 or above 40 kilograms per square meters; having history of at least 15 days fasting during 2mouths before Ramadan; having at least 5 days not fasting during Ramadan
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of medical sciences
Street address
Shiraz University of medical sciences, Zand street, Shiraz
City
Shiraz
Postal code
Approval date
2017-05-20, 1396/02/30
Ethics committee reference number
IR.SUMS.REC.1396.34
Health conditions studied
1
Description of health condition studied
traditional medicine based food regime and behavior
ICD-10 code
Y98
ICD-10 code description
Lifestyle-related condition
Primary outcomes
1
Description
Blood urea nitrogen(BUN)
Timepoint
before Intervention, after Intervention
Method of measurement
by standard device- in mg/dl
2
Description
Height
Timepoint
before Intervention, after Intervention, three mouths after Intervention
Method of measurement
By meter, in cm
3
Description
weight
Timepoint
before Intervention, after Intervention, three mouths after Intervention
Method of measurement
By balance, in kg
4
Description
blood Pressure
Timepoint
before Intervention, after Intervention, three mouths after Intervention
Method of measurement
by Mercury barometric- in mm Hg
5
Description
Round the abdomen
Timepoint
before Intervention, after Intervention, three mouths after Intervention
Method of measurement
By meter, in cm
6
Description
Hip circumference
Timepoint
before Intervention, after Intervention, three mouths after Intervention
Method of measurement
By meter, in cm
7
Description
Mental Health Indicators
Timepoint
before Intervention, after Intervention, three mouths after Intervention
Method of measurement
By questionnaires: WQ5، HAD5، IPAQ، HQ28
8
Description
fasting blood suger
Timepoint
before Intervention, after Intervention
Method of measurement
by standard device- in mg/dl
9
Description
cholesterol
Timepoint
before Intervention, after Intervention
Method of measurement
by standard device- in mg/dl
10
Description
triglyceride
Timepoint
before Intervention, after Intervention
Method of measurement
by standard device- in mg/dl
11
Description
LDL cholesterol
Timepoint
before Intervention, after Intervention
Method of measurement
by standard device- in mg/dl
12
Description
HDL cholesterol
Timepoint
before Intervention, after Intervention
Method of measurement
by standard device- in mg/dl
13
Description
AST
Timepoint
before Intervention, after Intervention
Method of measurement
by standard device- in u/L
14
Description
ALT
Timepoint
before Intervention, after Intervention
Method of measurement
by standard device- in u/L
15
Description
creatinine
Timepoint
before Intervention, after Intervention
Method of measurement
by standard device- in mg/dl
Secondary outcomes
empty
Intervention groups
1
Description
Type of intervention in Intervention group:
Traditional medicine tips training will be done through a booklet which published by Office of Traditional Medicine of the Ministry of Health of Iran in person within half an hour in Intervention group. In this booklet there are many tips about Less consuming sweets and industrial foods, consumption of warm liquid in breakfast time, avoiding Eating different foods at the same time, Full food chewing on meals, avoiding consumption of water and food Simultaneously.
Category
Lifestyle
2
Description
Type of intervention in control group:
For the control group, Traditional medicine tips training and consultation will not be done. (No action)
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
8 large mosques of Shiraz from different regions - including the holy Mosque of Fatemeh Zahra
Full name of responsible person
Seyed Hossein Owji
Street address
8 different addresses from different parts of the city - including the Fatemeh Zahra Mosque in the Zand street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Pasalar
Street address
Medical School, Imam Hossein Square, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Hossein Owji
Position
Medical Student
Other areas of specialty/work
Street address
Imam Hossein Square- Medical School
City
Shiraz
Postal code
Phone
+98 000
Fax
Email
owji_h@sums.ac.irs.h.owji.j.e@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Pasalar
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Hossein Square- Medical School
City
Shiraz
Postal code
Phone
+98 71 3233 8476
Fax
Email
pasalar@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Hossein Owji
Position
Medical Student
Other areas of specialty/work
Street address
Imam Hossein Square- Medical School
City
Shiraz
Postal code
Phone
00
Fax
Email
owji_h@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)