NCT05915520

Brief Summary

functional dyspepsia is very common between geriatric population

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
40

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

Click on a node to explore related trials.

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
27 days until next milestone

Study Start

First participant enrolled

July 20, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

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

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

  • cortisol

    it is a serum stress marker

    It will be measured after 8 weeks

Secondary Outcomes (4)

  • depression sub component of Hospital anxiety and depression scale

    It will be measured after 8 weeks

  • anxiety sub component of Hospital anxiety and depression scale

    It will be measured after 8 weeks

  • Glasgow dyspepsia severity score

    It will be measured after 8 weeks

  • visual analogue scale

    It will be measured after 8 weeks

Study Arms (2)

group A

EXPERIMENTAL

the 20-geriatric group will receive 5-session per-week 40-minute baduinjuin for 8 weeks plus the daily dose of pantoprazole (40 mg orally administered tablet drug)

Behavioral: baduinjuin activities

group B

OTHER

this 20-geriatric group will receive the daily dose of pantoprazole (40 mg orally administered tablet drug for 8 weeks .

Other: pantoprazole

Interventions

baduinjuin activitiesBEHAVIORAL

in this 20-geriatric group will receive 5-session per-week 40-minute baduinjuin for 8 weeks plus the daily dose of pantoprazole (40 mg orally administered tablet drug)

group A
pantoprazoleOTHER

in this 20-geriatric group will receive the daily dose of pantoprazole (40 mg orally administered tablet drug for 8 weeks .

group B

Eligibility Criteria

Age65 Years - 75 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsself-representation of gender identity.
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • functional dyspepsia complaints
  • geriatric population

You may not qualify if:

  • cardiac complaints
  • respiratory complaints
  • articular complaints

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo Unoversity

Giza, Egypt

RECRUITING

MeSH Terms

Interventions

Pantoprazole

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ali MA Ismail

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali MA Ismail

CONTACT

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

Ali MA Ismail, lecturer

CONTACT

ali.mohamed@pt.cu.edu.eg

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 20, 2023

Primary Completion

January 30, 2024

Study Completion

January 30, 2024

Last Updated

June 23, 2023

Record last verified: 2023-06

Locations

EG(1)