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General information
empty
We want to update title by simply placing one word ( patients) at the last of line
Plus also updating the position of the person responsible for scientific inquiries
We want to update title by simply placing one word ( patients) at the last of line Plus also updating the position of the person responsible for scientific inquiries
Evaluation of therapeutic potential of deep tissue foot massage with or without jasmine oil in hypertensive patients and diabetic
Evaluation of therapeutic potential of deep tissue foot massage with or without jasmine oil in hypertensive and diabetic patients
Evaluation of therapeutic potential of deep tissue foot massage with or without jasmine oil in hypertensive patients and diabetic patients
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Muhammad Nawaz Shareef University of Agriculture, Multan
Name of organization / entity - Persian:
Full name of responsible person - English: Imran Ahmad Khan
Full name of responsible person - Persian:
Position - English: Coordinator Department of Physiology and Pharmacology
Position - Persian:
Latest degree: phd
Area of specialty/work: 41
Area of specialty/work title - English: Cardiovascular Pharmacology
Area of specialty/work title - Persian:
Street address - English: Hbl Street
Street address - Persian:
City - English: Multan
City - Persian:
Province: Punjab
Province - English: Punjab
Province - Persian:
contact.provinces_available:
Country: Pakistan
Postal code: 66000
Phone: +92 333 6120602
Mobile: +92 333 6120602
Fax:
Email: imran.ahmad@mnsuam.edu.pk
Web page address:
contact.organization_id:
Name of organization / entity - English: Muhammad Nawaz Shareef University of Agriculture, Multan
Name of organization / entity - Persian:
Full name of responsible person - English: Imran Ahmad Khan
Full name of responsible person - Persian:
Position - English: Coordinator Department of Pharmacology and Physiology
Position - Persian:
Latest degree: phd
Area of specialty/work: 41
Area of specialty/work title - English: Cardiovascular Pharmacology
Area of specialty/work title - Persian:
Street address - English: Hbl Street
Street address - Persian:
City - English: Multan
City - Persian:
Province: Punjab
Province - English: Punjab
Province - Persian:
contact.provinces_available:
Country: Pakistan
Postal code: 66000
Phone: +92 333 6120602
Mobile: +92 333 6120602
Fax:
Email: imran.ahmad@mnsuam.edu.pk
Web page address:
contact.organization_id: Name of organization / entity - English: Muhammad Nawaz Shareef University of Agriculture, Multan Name of organization / entity - Persian: Full name of responsible person - English: Imran Ahmad Khan Full name of responsible person - Persian: Position - English: Coordinator Department of PhysiologyPharmacology and PharmacologyPhysiology Position - Persian: Latest degree: phd Area of specialty/work: 41 Area of specialty/work title - English: Cardiovascular Pharmacology Area of specialty/work title - Persian: Street address - English: Hbl Street Street address - Persian: City - English: Multan City - Persian: Province: Punjab Province - English: Punjab Province - Persian: contact.provinces_available: Country: Pakistan Postal code: 66000 Phone: +92 333 6120602 Mobile: +92 333 6120602 Fax: Email: imran.ahmad@mnsuam.edu.pk Web page address:
Protocol summary
Study aim
Therapeutic deep tissue foot massage with jasmine oil in diabetes and hypertensive patients and their effects on blood pressure, heart rate, oxygen saturation, insulin level, temperature, respiration rate, lipid profile.
Design
Lottery method, community based, parallel group, double blinded, randomized control trial and 290 patients will be enrolled.
Settings and conduct
Study will be conducted at Muhammad Institute of Medical and Allied Sciences Multan after approval from Institutional ethical committee.
Participants/Inclusion and exclusion criteria
Incision criteria : Age group of 23-70 years ,Both Genders (Male, Female), Educated and uneducated Diabetic patient, Hypertensive patients,Married and unmarried.Exclusion criteria: Any type of mental disability,Lactating females,Having any type of physical disability,Pregnant females,Any type of major surgery.
Intervention groups
The three treatment groups will be treated with therapeutic deep tissue massage with three ways: first group will be treated with jasmine oil manually massage, second group will be treated electric palm massage with jasmine oil massage and third group will be treated with electric palm massager with-out jasmine oil. The deep tissue foot massage will be applied by three ways on the feet of diabetics and hypertensive patients for 20 consecutive days. Each session will be 40 minutes per day. Massage will be applied for 20 minutes on each foot. After 20 days we will compare per and post blood pressure and glucose level in hypertensive and diabetics patients. We will measure objective data heart rate, respiration rate, blood pressure, and glucose level and oxygen saturation.
Main outcome variables
Increasing insulin and blood circulation in diabetic patients and will help in reducing mean of arterial pressure (MAP), heart rate, respiratory rate, and increases oxygen saturation in hypertensive patients.
General information
Reason for update
We want to update title by simply placing one word ( patients) at the last of line
Plus also updating the position of the person responsible for scientific inquiries
Acronym
IRCT registration information
IRCT registration number:IRCT20230103057033N2
Registration date:2023-02-25, 1401/12/06
Registration timing:registered_while_recruiting
Last update:2023-03-17, 1401/12/26
Update count:2
Registration date
2023-02-25, 1401/12/06
Registrant information
Name
Ujala Hameed
Name of organization / entity
Ali ul Murtaza Departement of Rehabilitation Multan
Country
Pakistan
Phone
+92 316 6484756
Email address
ujalahameed947@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-10, 1401/08/19
Expected recruitment end date
2023-04-10, 1402/01/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic potential of deep tissue foot massage with or without jasmine oil in hypertensive and diabetic patients
Public title
Deep tissue foot massage with or without jasmine oil in hypertensive patients and diabetic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age group of 23-70 years
Diabetic patients
Educated and uneducated
Married and unmarried
Hypertensive patients
Both Genders (Male, Female)
Exclusion criteria:
Any type of mental disability
MI
Pregnant females
Chronic illness related to cardiorespiratory ailments
Any type of major surgery
Having any type of physical disability
Asthma
Angina
History of chest pain
Bronchitis
Lactating females
Age
From 23 years old to 70 years old
Gender
Both
Phase
1
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
290
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization. We will use sealed envelops for lottery method and randomization of participants will be done. Randomization of participants in groups by lottery method and statistical analysis without biasness.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blinded study will be done by keeping blind i-e the physiotherapist as Investigator and data analyser
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Muhammad Institute of Medical and Allied Sciences Multan
Street address
Hbl street
City
Multan
Postal code
66000
Approval date
2022-10-20, 1401/07/28
Ethics committee reference number
MIMAS/22/IRB/IAK.Durrani
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
2
Description of health condition studied
Hypertension
ICD-10 code
I15.9
ICD-10 code description
Secondary hypertension, unspecified
Primary outcomes
1
Description
Increase in Blood circulation and insulin secretion in diabetic patients
Timepoint
before intervention and 3 weeks after intervention
Method of measurement
Blood glucose level by glucometer
2
Description
Mean arterial pressure
Timepoint
3 weeks
Method of measurement
Mercury manometer
3
Description
Heart rate
Timepoint
3 weeks
Method of measurement
Heart rate measuring device
4
Description
Oxygen saturation
Timepoint
3 weeks
Method of measurement
Pulse oximeter
5
Description
Respiration rate
Timepoint
3 weeks
Method of measurement
Manually
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Will be treated with jasmine oil.Diabetics and hypertensive patients will receive therapeutic deep tissue foot massage with jasmine oil. A glucometer will be used to monitor blood glucose levels in patients (both diabetic and hypertensive) via finger-prick testing. And blood pressure will be measured by mercury manometer, blood cholesterol (lipid profile) will be measured by lipid measuring device, oxygen saturation by pulse oximeter and temperature by thermometer will be monitored and body mass index (height, weight, body fat) of both diabetics and hypertensive patients will be measured by BMI scale before massage and after massage will be measured. After 3 weeks all these parameters will be measured again.
Category
Treatment - Drugs
2
Description
Intervention group 1: Will be treated with electrical massager and jasmine oil. Therapeutic deep tissue foot massage with jasmine oil manually , electric palm massager with jasmine oil, and electric palm massager without jasmine oil will be applied in diabetics and hypertensive patients. A glucometer will be used to monitor blood glucose levels in patients (both diabetic and hypertensive) via finger-prick testing. And blood pressure will be measured by mercury manometer, blood cholesterol (lipid profile) will be measured by lipid measuring device, oxygen saturation by pulse oximeter and temperature by thermometer will be monitored and body mass index (height, weight, body fat) of both diabetics and hypertensive patients will be measured by BMI scale before massage and after massage will be measured. After 3 weeks all these parameters will be measured again.
Category
Treatment - Drugs
3
Description
Intervention group 2: Will be treated with electrical massager without jasmine oil.electric palm massager without jasmine oil will be applied in diabetics and hypertensive patients. A glucometer will be used to monitor blood glucose levels in patients (both diabetic and hypertensive) via finger-prick testing. And blood pressure will be measured by mercury manometer, blood cholesterol (lipid profile) will be measured by lipid measuring device, oxygen saturation by pulse oximeter and temperature by thermometer will be monitored and body mass index (height, weight, body fat) of both diabetics and hypertensive patients will be measured by BMI scale before massage and after massage will be measured. After 3 weeks all these parameters will be measured again.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali-Ul-Murtaza Department of Rehabilitation Sciences,Muhammad Institute
Full name of responsible person
Maliha Khalid Khan
Street address
Hbl Street
City
Multan
Postal code
66000
Phone
+92 312 6827130
Email
malihatareen1997@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences
Full name of responsible person
Imran Ahmad Khan
Street address
Hbl Street
City
Multan
Postal code
66000
Phone
+92 333 6120602
Email
imranahmadkhandurrani@gmail.com
Grant name
Student fund
Grant code / Reference number
26012023
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Muhammad Institute of Medical and Allied Sciences
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences
Full name of responsible person
Maliha Khalid Khan
Position
Demonstrator
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Hbl Street
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 312 6827130
Email
malihatareen1997@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Muhammad Nawaz Shareef University of Agriculture, Multan
Full name of responsible person
Imran Ahmad Khan
Position
Coordinator Department of Pharmacology and Physiology
Latest degree
Ph.D.
Other areas of specialty/work
Cardiovascular Pharmacology
Street address
Hbl Street
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 333 6120602
Email
imran.ahmad@mnsuam.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences
Full name of responsible person
Ujala Hameed
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Hbl Street
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 316 6484756
Email
ujalahameed947@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
There is no further formation
When the data will become available and for how long
There is no further formation
To whom data/document is available
There is no further formation
Under which criteria data/document could be used
There is no further formation
From where data/document is obtainable
There is no further formation
What processes are involved for a request to access data/document