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Effect of Laser Acupuncture Alone or Combined With Pranayama Exercise on Inflammation in Allergic Rhinitis

Primary Purpose

Allergic Rhinitis

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pranayama plus acupoint stimulation by laser
acupoint stimulation by laser
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • allergic rhinitis children
  • physician-based diagnosis of allergic rhinitis

Exclusion Criteria:

  • children with intellectual disabilities
  • chest disease or heart disease or local congenital nose deformities
  • participants received within-previous-six-months self-prescribed or by-therapist prescribed complementary therapies

Sites / Locations

  • Cairo UnoversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

pranayama and acupoint stimulation by laser

acupoint stimulation by laser

Arm Description

for 6 weeks,This 30-children group will receive 2-session per-week laser stimulation to some selected acupoints and daily pranyama exercises (nearly every session will be one hour), the stimulated bilateral acupoints will be (LI 19, LI 20, ST2, and ST4. ST6, ST7, ST17, ST36, SI18, BL2, GB14, GV24 and EXHN5). Every acupoint will be stimulated with laser power of 100 mw that will be used on a spot area of 1 cm2 for 1 minute. this group will receive also pranayama session (applied daily, one hour approximately, for six weeks) will be (alternate nostril pranayama, diaphragmatic pranayama, rapid abdominal pranayama, Bhramari pranayama)

for six weeks, This 30-children group will receive 2-session per-week laser stimulation to some selected acupoints. The stimulated bilateral points will be (LI 19, LI 20, ST2, and ST4. ST6, ST7, ST17, ST36, SI18, BL2, GB14, GV24 and EXHN5). Every acupoint will be stimulated with laser power of 100 mw that will be used on a spot area of 1 cm2 for 1 minute.

Outcomes

Primary Outcome Measures

erothrocyte sidemention rate
it is a inflammatory marker in serum

Secondary Outcome Measures

Immunoglobulin E
it is an antibody in the serum
interleukin 1-beta
it is a inflammatory marker in serum
C-reactive protein
it is a inflammatory marker in serum
total eosinophil count
it is a inflammatory marker in serum

Full Information

First Posted
September 21, 2022
Last Updated
September 21, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05553483
Brief Title
Effect of Laser Acupuncture Alone or Combined With Pranayama Exercise on Inflammation in Allergic Rhinitis
Official Title
Comparing the Effect of Laser Acupuncture Alone or Combined With Pranayama Exercise on Inflammatory Status/Markers in Children With Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Allergic rhinitis (AR) represents one of the most common global health problems with seriously increasing incidence over the last decades.The goal of the treatment of rhinitis is to prevent or reduce the symptoms through reduction of the inflammation of affected tissues. Acupuncture and pranayama yoga exercises had reported a significant improvement in daily symptoms and an increase of symptom-free days in many studies enrolling patients.
Detailed Description
Sixty Egyptian children with allergic rhinitis, after randomization, will be divided to 2 groups; the first 30-children group will receive 2-session per-week laser stimulation for 6 weeks to some selected acupoints and daily pranyama exercises (nearly every session will be one hour, for six weeks), the second group will receive 2-session per-week laser stimulation for six weeks to some bilateral selected acupoints. the stimulated points will be (LI 19, LI 20, ST2, and ST4. ST6, ST7, ST17, ST36, SI18, BL2, GB14, GV24 and EXHN5). Every acupoint will be stimulated with laser power of 100 mw that will be used on a spot area of 1 cm2 for 1 minute.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pranayama and acupoint stimulation by laser
Arm Type
Experimental
Arm Description
for 6 weeks,This 30-children group will receive 2-session per-week laser stimulation to some selected acupoints and daily pranyama exercises (nearly every session will be one hour), the stimulated bilateral acupoints will be (LI 19, LI 20, ST2, and ST4. ST6, ST7, ST17, ST36, SI18, BL2, GB14, GV24 and EXHN5). Every acupoint will be stimulated with laser power of 100 mw that will be used on a spot area of 1 cm2 for 1 minute. this group will receive also pranayama session (applied daily, one hour approximately, for six weeks) will be (alternate nostril pranayama, diaphragmatic pranayama, rapid abdominal pranayama, Bhramari pranayama)
Arm Title
acupoint stimulation by laser
Arm Type
Active Comparator
Arm Description
for six weeks, This 30-children group will receive 2-session per-week laser stimulation to some selected acupoints. The stimulated bilateral points will be (LI 19, LI 20, ST2, and ST4. ST6, ST7, ST17, ST36, SI18, BL2, GB14, GV24 and EXHN5). Every acupoint will be stimulated with laser power of 100 mw that will be used on a spot area of 1 cm2 for 1 minute.
Intervention Type
Other
Intervention Name(s)
pranayama plus acupoint stimulation by laser
Intervention Description
This group will receive 2-session per-week laser stimulation (for six weeks) to some selected acupoints and daily pranyama exercises (nearly every session will be one hour), the stimulated bilateral acupoints will be (LI 19, LI 20, ST2, and ST4. ST6, ST7, ST17, ST36, SI18, BL2, GB14, GV24 and EXHN5). Every acupoint will be stimulated with laser power of 100 mw that will be used on a spot area of 1 cm2 for 1 minute. this group will receive also pranayama session (applied daily, one hour approximately, for six weeks) composed from (alternate nostril pranayama, diaphragmatic pranayama, rapid abdominal pranayama, Bhramari pranayama ).
Intervention Type
Other
Intervention Name(s)
acupoint stimulation by laser
Intervention Description
This group will receive 2-session per-week laser stimulation (for six weeks) to some selected acupoints. The stimulated bilateral acupoints will be (LI 19, LI 20, ST2, and ST4. ST6, ST7, ST17, ST36, SI18, BL2,GB14, GV24 and EXHN5). Every acupoint will be stimulated with laser power of 100 mw that will be used on a spot area of 1 cm2 for 1 minute.
Primary Outcome Measure Information:
Title
erothrocyte sidemention rate
Description
it is a inflammatory marker in serum
Time Frame
It will be measured after 6 weeks
Secondary Outcome Measure Information:
Title
Immunoglobulin E
Description
it is an antibody in the serum
Time Frame
It will be measured after 6 weeks
Title
interleukin 1-beta
Description
it is a inflammatory marker in serum
Time Frame
It will be measured after 6 weeks
Title
C-reactive protein
Description
it is a inflammatory marker in serum
Time Frame
It will be measured after 6 weeks
Title
total eosinophil count
Description
it is a inflammatory marker in serum
Time Frame
It will be measured after 6 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
from the governmental birth certificate, gender is written in it
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: allergic rhinitis children physician-based diagnosis of allergic rhinitis Exclusion Criteria: children with intellectual disabilities chest disease or heart disease or local congenital nose deformities participants received within-previous-six-months self-prescribed or by-therapist prescribed complementary therapies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
ali.mohamed@pt.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
heba mousa, Lecturer
Email
hebamousa14@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo Unoversity
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Phone
01005154209
Email
allooka2012@gmail.com

12. IPD Sharing Statement

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Effect of Laser Acupuncture Alone or Combined With Pranayama Exercise on Inflammation in Allergic Rhinitis

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