Determining the efficacy of laser acupuncture in the treatment of central obesity
Determining the Effectiveness of Acupuncture Laser in Improving Obesity Metabolic Problems
Design
40 patients are divided into case and control groups according to random number table with 1: 1 ratio The assigned group is consecutively inserted into dark envelopes. This envelope is used only after evaluations Initially each individual is returned by a physician and neither the patient nor the clinical evaluator will be informed of their treatment group
Settings and conduct
24 sessions, three sessions per week, for all patients, including case and control, are given at specified intervals for ten seconds
Participants/Inclusion and exclusion criteria
Body mass ≥ 25 and complete consent to participate in the study and complete the follow-up and follow-up are excluded. Epilepsy and Cancer Epilepsy Mental Disorders, Infectious Diseases of the Skin or Light Sensitivity Are Not Included in the Stud
Intervention groups
The subjects in the study were randomly divided into intervention and control groups. The intervention group will be treated with laser acupuncture three times a week for 4 weeks The acupuncture laser is based on a well documented global system and on previously documented locations No needles are used in this method, and only low-power laser light is used to stimulate the spot. In the control group similar points with the same frequency are treated with a silent laser for placebo effect
Main outcome variables
Body mass changes and weight changes and hunger changes as well as body size changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111121008146N31
Registration date:2019-10-14, 1398/07/22
Registration timing:retrospective
Last update:2019-10-14, 1398/07/22
Update count:0
Registration date
2019-10-14, 1398/07/22
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
Recruitment complete
Funding source
Expected recruitment start date
2018-01-20, 1396/10/30
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of laser acupuncture in the treatment of obesity and associated metabolic disorders
Public title
The effect of laser in the treatment of obesity
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Estimation of body mass index ≥ 25 and complete consent to participate in the study and complete the treatment process
Exclusion criteria:
patients with known diseases such as cardiovascular
diabetes mellitus
If you have epilepsy
Tumors
cancer
mental disorders
contagious skin infections
light-sensitization
not be pregnant or breastfeeding
They were excluded if they took any of the drugs that were effective on weight within one month before the study
Kidney Disorders
Endocrine Disorders
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
All patients are divided into two groups of case and control on the basis of 1: 1 random numbers table.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi ST. Yemen street, Shahid Chamran highway, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Approval date
2018-01-06, 1396/10/16
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.862
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E74.09
ICD-10 code description
Other glycogen storage disease
Primary outcomes
1
Description
Body mass
Timepoint
One time before patients were assigned to groups and one time at the end time
Method of measurement
Laboratory testing and ultrasound
Secondary outcomes
1
Description
Body mass and body size changes due to fat loss
Timepoint
One time before patients were assigned to groups and one time at the end time
Method of measurement
Laboratory testing and sonography and sf36 questionnaire
Intervention groups
1
Description
Intervention group: Patients undergo low-power laser. It is non-toxic and non-toxic and has high immunity. Light is shed at very specific points according to acupuncture for ten seconds and three times a week
Category
Treatment - Other
2
Description
Control group: Patients are put on a low-power laser and are given acupuncture points for ten seconds and three times a week
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Mohammad Reza Razaghi
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Razaghi
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi ST. Yemen street, Shahid Chamran highway, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@yahoo.com
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
Mohamadreza razaghi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Others
Street address
Shohada Hospital-Tajrish
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Reza Razaghi
Position
Professor,
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Reza Razaghi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@yahoo.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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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