NCT05553483

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 21, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

1.2 years

First QC Date

September 21, 2022

Last Update Submit

September 21, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • erothrocyte sidemention rate

    it is a inflammatory marker in serum

    It will be measured after 6 weeks

Secondary Outcomes (4)

  • Immunoglobulin E

    It will be measured after 6 weeks

  • interleukin 1-beta

    It will be measured after 6 weeks

  • C-reactive protein

    It will be measured after 6 weeks

  • total eosinophil count

    It will be measured after 6 weeks

Study Arms (2)

pranayama and acupoint stimulation by laser

EXPERIMENTAL

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)

Other: pranayama plus acupoint stimulation by laser

acupoint stimulation by laser

ACTIVE COMPARATOR

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.

Other: acupoint stimulation by laser

Interventions

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 ).

pranayama and 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.

acupoint stimulation by laser

Eligibility Criteria

Age12 Years - 17 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsfrom the governmental birth certificate, gender is written in it
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo Unoversity

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Ali Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Ismail, lecturer

CONTACT

heba mousa, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

September 21, 2022

First Posted

September 23, 2022

Study Start

September 15, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

September 23, 2022

Record last verified: 2022-09

Locations