NCT05915507

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 geriatric 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 Jul 2023

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

June 13, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

July 5, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

June 13, 2023

Last Update Submit

June 13, 2023

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • erothrocyte sidemention rate

    it is a inflammatory marker in serum

    It will be measured after 8 weeks

Secondary Outcomes (4)

  • Immunoglobulin E

    It will be measured after 8 weeks

  • interleukin 1-beta

    It will be measured after 8 weeks

  • C-reactive protein

    It will be measured after 8 weeks

  • total eosinophil count

    It will be measured after 8 weeks

Study Arms (2)

pranayama and acupoint stimulation by laser

EXPERIMENTAL

the 30-geriatric group will receive 3-session per-week laser stimulation for 8 weeks to some selected acupoints and daily pranyama exercises (nearly every session will be one hour, for 8 weeks), 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.

Other: pranayama plus acupoint stimulation by laser

acupoint stimulation by laser

ACTIVE COMPARATOR

the 30-geriatric group will receive 3-session per-week laser stimulation for 8 weeks to some selected acupoints (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

pranayama plus acupoint stimulation by laserOTHER

This group will receive 3-session per-week laser stimulation (for eight 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 eight weeks) composed from (alternate nostril pranayama, diaphragmatic pranayama, rapid abdominal pranayama, Bhramari pranayama )

pranayama and acupoint stimulation by laser
acupoint stimulation by laserOTHER

This group will receive 3-session per-week laser stimulation (for eight 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

Age65 Years - 75 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsfrom the governmental birth certificate, gender is written in it
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • geriatrics with allergic rhinitis

You may not qualify if:

  • chest disease or heart disease or local congenital nose deformities participants received within-previous-eight-months self-prescribed or by-therapist prescribed complementary therapies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy Cairo University

Giza, Dokki, Egypt

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Ali MA Ismail

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali MA Ismail, lecturer

CONTACT

01005154209ali.mohamed@pt.cu.edu.eg

heba mousa, lecturer

CONTACT

hebamousa14@yahoo.com

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 Internal Medicine and Geriatrics

Study Record Dates

First Submitted

June 13, 2023

First Posted

June 23, 2023

Study Start

July 5, 2023

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

June 23, 2023

Record last verified: 2023-06

Locations

EG(1)