Back to resultsBaduanjin Program Effect on Geriatric Functional Dyspepsia
Primary Purpose
Functional Dyspepsia
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
baduinjuin activities
pantoprazole
Sponsored by
About this trial
This is an interventional treatment trial for Functional Dyspepsia
Eligibility Criteria
Inclusion Criteria: functional dyspepsia complaints geriatric population Exclusion Criteria: cardiac complaints respiratory complaints articular complaints
Sites / Locations
- Cairo UnoversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
group A
group B
Arm Description
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)
this 20-geriatric group will receive the daily dose of pantoprazole (40 mg orally administered tablet drug for 8 weeks .
Outcomes
Primary Outcome Measures
cortisol
it is a serum stress marker
Secondary Outcome Measures
depression sub component of Hospital anxiety and depression scale
It will be measure depression
anxiety sub component of Hospital anxiety and depression scale
It will be measure anxiety
Glasgow dyspepsia severity score
It will be used to assess functional dyspepsia
visual analogue scale
It will be used to assess abdominal symptoms of geriatric patients regarding functional dyspepsia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05915520
Brief Title
Baduanjin Program Effect on Geriatric Functional Dyspepsia
Official Title
Baduanjin Program Effect on Geriatric Functional Dyspepsia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2023 (Anticipated)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
January 30, 2024 (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
functional dyspepsia is very common between geriatric population
Detailed Description
Forty Egyptian geriatrics with functional dyspepsia, after randomization, will be divided to 2 groups; the first 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. in the other 20-geriatric group, the daily dose of drug will be administered only for 8 weeks .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Experimental
Arm Description
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)
Arm Title
group B
Arm Type
Other
Arm Description
this 20-geriatric group will receive the daily dose of pantoprazole (40 mg orally administered tablet drug for 8 weeks .
Intervention Type
Behavioral
Intervention Name(s)
baduinjuin activities
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
pantoprazole
Intervention Description
in this 20-geriatric group will receive the daily dose of pantoprazole (40 mg orally administered tablet drug for 8 weeks .
Primary Outcome Measure Information:
Title
cortisol
Description
it is a serum stress marker
Time Frame
It will be measured after 8 weeks
Secondary Outcome Measure Information:
Title
depression sub component of Hospital anxiety and depression scale
Description
It will be measure depression
Time Frame
It will be measured after 8 weeks
Title
anxiety sub component of Hospital anxiety and depression scale
Description
It will be measure anxiety
Time Frame
It will be measured after 8 weeks
Title
Glasgow dyspepsia severity score
Description
It will be used to assess functional dyspepsia
Time Frame
It will be measured after 8 weeks
Title
visual analogue scale
Description
It will be used to assess abdominal symptoms of geriatric patients regarding functional dyspepsia
Time Frame
It will be measured after 8 weeks
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
self-representation of gender identity.
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
functional dyspepsia complaints
geriatric population
Exclusion Criteria:
cardiac complaints
respiratory complaints
articular complaints
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali MA Ismail
Phone
01005154209
Email
ali.mohamed@pt.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ali MA Ismail, lecturer
Email
ali.mohamed@pt.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali MA Ismail
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
Learn more about this trial
Baduanjin Program Effect on Geriatric Functional Dyspepsia
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