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

Allergic Rhinitis Clinical Trial

Official title:

Comparing the Effect of Laser Acupuncture Alone or Combined With Pranayama Exercise on Inflammatory Status/Markers in Children With Allergic Rhinitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05553483
• Other study ID #: P.T.REC/012/003341
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: September 2022
• Source: Cairo University
• Contact: Ali Ismail, lecturer
• Phone: 02 01005154209
• Email: ali.mohamed[@]pt.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Other:
• pranayama plus acupoint stimulation by laser
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 ).
• acupoint stimulation by laser
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.

Locations

Country	Name	City	State
Egypt	Cairo Unoversity	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	erothrocyte sidemention rate	it is a inflammatory marker in serum	It will be measured after 6 weeks
Secondary	Immunoglobulin E	it is an antibody in the serum	It will be measured after 6 weeks
Secondary	interleukin 1-beta	it is a inflammatory marker in serum	It will be measured after 6 weeks
Secondary	C-reactive protein	it is a inflammatory marker in serum	It will be measured after 6 weeks
Secondary	total eosinophil count	it is a inflammatory marker in serum	It will be measured after 6 weeks