This research is a clinical trial. The purpose of this research is to determine the effect of henna on saturation pressure Oxygen (spo2), reading by pulse oximetry. Research population includes all healthy and cardio-respiratory patients' women with 20 – 60 years old with normal hemoglobin and normal body temperature that are eligible to study. Research settings are Intensive Care Units and Internal Medicine Ward and Dormitories of Tehran University of Medical Sciences. Samples consist of 40 healthy and young women, living in a Dormitory of Tehran University of Medical Sciences and 40 patients with cardiopulmonary disease. Sampling is convenience. Before intervention plasma sample will be collected from all of participants and body temperature will be measured by thermometer. Individuals will be participated in this study if their Hb is 12-15 gr/dl and body temperatures are between 36.8 -37.4°C. At first demographic data and disease information will be gathered, and then SPO2 will be measured in room temperature by calibrated pulse oximetry. If SPO2 is in the expected range (95-100% in healthy individual and up to 65%in patient group), red henna (Iranian henna) will be put on index finger’s nail of non dominant hand and the other finger of the same hand will be considered as control. Then SPO2 will be measured by two calibrated pulse oximetry devices simultaneously. Finally, the value that will be displayed after ten minutes by two devices will be documented in an information form.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201209061599N20
Registration date:2012-12-29, 1391/10/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-29, 1391/10/09
Registrant information
Name
Mitra Zolfaghari
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
zolfaghm@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2012-11-01, 1391/08/11
Expected recruitment end date
2013-03-01, 1391/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of henna on pulse oximetry results in healthy and cardiopulmonary patients female.
Public title
Effect of henna on pulse oximetry results
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
1.20 - 60 years old 2. Hemoglobin(Hb) within 12-15 mg / dl 3 - normal body temperature (36 .8 -37 .4 °C)
Exclusion criteria:
1- unconscious patients
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
N/A
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 Tehran University of Medical Science
Street address
Ghods St. Tehran
City
Tehran
Postal code
Approval date
2012-09-26, 1391/07/05
Ethics committee reference number
64984
Health conditions studied
1
Description of health condition studied
Pneumonia
ICD-10 code
J18
ICD-10 code description
Pneumonia, organism unspecified
2
Description of health condition studied
Bronchitis
ICD-10 code
J40
ICD-10 code description
Bronchitis, not specified as acute or chronic
3
Description of health condition studied
Pleural effusion
ICD-10 code
J90
ICD-10 code description
Pleural effusion, not elsewhere classified
4
Description of health condition studied
Hypertension
ICD-10 code
I11
ICD-10 code description
Hypertensive heart disease
5
Description of health condition studied
Acute myocardial infarction
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction
6
Description of health condition studied
Chronic ischaemic heart disease
ICD-10 code
I25
ICD-10 code description
Chronic ischaemic heart disease
Primary outcomes
1
Description
Oxygen saturation percentage
Timepoint
one hour before intervention and one day after intervention
Method of measurement
pulse oximetry
Secondary outcomes
empty
Intervention groups
1
Description
intervention 1: group 1: putting Iranian red henna with generic name " Lawsonia inermis "on nondominan hand of index finger nail in healthy participants that provide 1 gr henna dissolve in 10 CC water and put on finger nail for 2 hours.
Category
Other
2
Description
intervention 1: group 2: putting Iranian red henna with generic name " Lawsonia inermis "on nondominan hand of index finger nail in cardiac patient participants that provide 1 gr henna dissolve in 10 CC water and put on finger nail for 2 hours.
Category
Other
3
Description
1: group 3: putting Iranian red henna with generic name " Lawsonia inermis "on nondominan hand of index finger nail in respiratory patient participants that provide 1 gr henna dissolve in 10 CC water and put on finger nail for 2 hours.
Category
Other
4
Description
intervention 2 : group 1 absence henna and other barrier on middle finger of nondominant hand in healthy participant
Category
Other
5
Description
intervention 2 : group 2 absence henna and other barrier on middle finger of nondominant hand in cardiac patients
Category
Other
6
Description
intervention 2 : group3 absence henna and other barrier on middle finger of nondominant hand in respiratory patients
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Parisa Moradi Majd
Street address
Gharib St.
City
Tehran
2
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Parisa Moradi Majd
Street address
Satar Khan St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Vice Chancellor for Research,Tehran University of Medical Sciences. Ghods St. Keshavarz Bv.
City
Tehran
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, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Parisa Moradi Majd
Position
Student of Master of Sciences
Other areas of specialty/work
Street address
No: 296 between Esfand and Eghbal, Esfahan St. Golestan, Ahwaz
City
Ahwaz
Postal code
Phone
+98 61 1374 3228
Fax
Email
moradimajdparisa@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mitra Zolfaghari
Position
PhD
Other areas of specialty/work
Street address
Tohid Sq. Nosrat St. Nursing and Midwifery College
City
Tehran
Postal code
Phone
+98 21 6105 4402
Fax
Email
zolfaghm@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parisa Moradi Majd
Position
Student of Master of Sciences
Other areas of specialty/work
Street address
No: 296 between Esfand and Eghbal, Esfahan St. Golestan, Ahwaz
City
Ahwaz
Postal code
Phone
+98 61 1374 3288
Fax
Email
moradimajdparisa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)