the aim of this study is investigating the factors determining the temperaments and the change of blood electrolyte and thyroid hormones after using hot traditional medicine. this study is an not-blind , non-placebo study of 50 healthy individuals between 18-70 y/o who is not pregnant or breastfeed and do not have any acute liver , kidney or heart disease. before and after using hot traditional medicine everyone gave a blood sample to measure the blood electrolyte, thyroid hormones, metanephrine and normetanephrine.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016101030246N1
Registration date:2017-09-22, 1396/06/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-22, 1396/06/31
Registrant information
Name
Iman Karimzadeh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3242 4128
Email address
karimzadee@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
government budget
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
investigating Blood electrolyte changes with the use of hot traditional medicine in healthy people
Public title
investigating factors determining the temperament of individuals
Purpose
Diagnostic
Inclusion/Exclusion criteria
inclusion criteria : general health , age 18-70 y/o ,
exclusion criteria : pregnancy , breastfeeding , any kind of acute liver , kidney or heart disease
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Shiraz University of Medical Sciences
Street address
Kharimkhanzand street-Beside Red Crescent
City
Shiraz
Postal code
Approval date
2016-05-29, 1395/03/09
Ethics committee reference number
IR.SUMS.REC.1395.35
Health conditions studied
1
Description of health condition studied
Temperament
ICD-10 code
Z00.0
ICD-10 code description
General medical examination
Primary outcomes
1
Description
peripheral blood electrolytes
Timepoint
befor and 1 week after intervention
Method of measurement
biochemistry methods
2
Description
peripheral thyroid hormones
Timepoint
befor and 1 week after intervention
Method of measurement
RIA
3
Description
metanephrine and nor metanephrine in peripheral blood
Timepoint
befor and 1 week after intervention
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
capsules containing Cuminum cyminum , 3 times a day after meal for 7 days for all individuals
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
emaddodin shirazi healthcare
Full name of responsible person
maryam roodaki
Street address
City
shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
shiraz university of medical sciences - research assistanc
Full name of responsible person
zohre abolhasanzadeh
Street address
next to red Crescent - Zand street - 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 - research assistanc
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
maryam roodaki
Position
pharmacy student
Other areas of specialty/work
Street address
collage of pharmacy - Karafarin street - 5 km after darvazeh qoran - shiraz
City
shiraz
Postal code
Phone
+7 132424128
Fax
Email
mrm.roodaki@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
iman karimzadeh
Position
PhD
Other areas of specialty/work
Street address
collage of pharmacy - Karafarin street- 5km after darvazeh qoran - shiraz
City
shiraz
Postal code
Phone
+98 71 3242 4128
Fax
Email
karimzadee@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
maryam roodaki
Position
pharmacy student
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)