Investigating the effectiveness of laser acupuncture in reducing blood pressure in patients with resistant blood pressure
Design
The one arm clinical trial, 20 patients with resistance hypertension
Settings and conduct
Patients referred to Cardiology Clinic of Shahada Tajrish medical center will be included in the study.
Participants/Inclusion and exclusion criteria
Patients with resistant systolic blood pressure of 140 to 160 mm Hg or resistant diastolic blood pressure of 85 to 95 mm Hg.
There is no need for emergency action
No treatment with corticosteroids and NSAID
Intervention groups
Acupuncture Laser
Main outcome variables
Systolic blood pressure
Diastolic blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111121008146N46
Registration date:2024-06-09, 1403/03/20
Registration timing:prospective
Last update:2024-06-09, 1403/03/20
Update count:0
Registration date
2024-06-09, 1403/03/20
Registrant information
Name
Mohammadreza Razaghi
Name of organization / entity
Laser application in medical sciences research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8021
Email address
laser.cntr@sbmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-09-23, 1404/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of laser acupuncture in reducing blood pressure in patients with resistant hypertension
Public title
The the effectiveness of laser acupuncture in reducing resistant hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Resistant hypertension
Exclusion criteria:
-Patients who are treated with corticosteroids and painkillers are not included in the study due to their direct effects on inflammation.
Patients with blood pressure higher than resistant systolic blood pressure of 140 to 160 mm Hg or resistant diastolic blood pressure of 85 to 95 mm Hg are not included in the study.
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
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
Ethics Committee in Biomedical Research,of laser application in meddical sciences research center
Street address
Laser application in medical sciences research center, shohada tajrish hospital, Shahrdari st, Tajrish sq
City
Tehran
Province
Tehran
Postal code
1989934370
Approval date
2024-05-08, 1403/02/19
Ethics committee reference number
IR.SBMU.LASER.REC.1403.005
Health conditions studied
1
Description of health condition studied
Resistance hypertention
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
systolic blood pressure
Timepoint
Before the study, after the end of the intervention, 1 month after the end of the intervention
Method of measurement
manometer
2
Description
Diastolic blood pressure
Timepoint
Before the study, after the end of the intervention, 1 month after the end of the intervention
Method of measurement
manometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: laser acupuncture
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Tajrish Medical center
Full name of responsible person
Behzad Hajimoradi
Street address
Shohada Tajrish Hospital, Shahrdari st, Tajrish sq, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8021
Fax
+98 21 2274 9221
Email
laser.cntr@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Yaman st, Danshjoo Blvd, Velenjak st
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Behzad Hajimoradi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Shohada Tajrish Hospital, Shahrdari st, Tajrish sq, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8021
Email
bhajimoradi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Arista Shojaeddin
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
Laser
Street address
Laser application in medical sciences research center, Shohada Tajrish Hospital, Shahrdari st, Tajrish sq
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8021
Email
dr.shojaedin@outlook.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Razzaghi
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Laser application in medical sciences research center, Shohada Tajrish Hospital, Shahrdari st, Tajrish sq, Tehran
City
Tehran
Province
East Azarbaijan
Postal code
1989934148
Phone
+98 21 2271 8021
Email
z.razaghi@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
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
It will be given in the article
When the data will become available and for how long
2025
To whom data/document is available
Researchers of the Laser Application in Medical Sciences Research Center
Under which criteria data/document could be used
If a similar study will be conducted
From where data/document is obtainable
Laser Application in Medical Sciences Research Center
What processes are involved for a request to access data/document