- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05915520
Baduanjin Program Effect on Geriatric Functional Dyspepsia
June 13, 2023 updated by: Ali Mohamed Ali ismail, Cairo University
functional dyspepsia is very common between geriatric population
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 .
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ali MA Ismail
- Phone Number: 01005154209
- Email: ali.mohamed@pt.cu.edu.eg
Study Contact Backup
- Name: Ali MA Ismail, lecturer
- Email: ali.mohamed@pt.cu.edu.eg
Study Locations
-
-
-
Giza, Egypt
- Recruiting
- Cairo Unoversity
-
Contact:
- Ali Ismail, lecturer
- Phone Number: 01005154209
- Email: allooka2012@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- functional dyspepsia complaints
- geriatric population
Exclusion Criteria:
- cardiac complaints
- respiratory complaints
- articular complaints
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: group A
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)
|
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)
|
Other: group B
this 20-geriatric group will receive the daily dose of pantoprazole (40 mg orally administered tablet drug for 8 weeks .
|
in this 20-geriatric group will receive the daily dose of pantoprazole (40 mg orally administered tablet drug for 8 weeks .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cortisol
Time Frame: It will be measured after 8 weeks
|
it is a serum stress marker
|
It will be measured after 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
depression sub component of Hospital anxiety and depression scale
Time Frame: It will be measured after 8 weeks
|
It will be measure depression
|
It will be measured after 8 weeks
|
anxiety sub component of Hospital anxiety and depression scale
Time Frame: It will be measured after 8 weeks
|
It will be measure anxiety
|
It will be measured after 8 weeks
|
Glasgow dyspepsia severity score
Time Frame: It will be measured after 8 weeks
|
It will be used to assess functional dyspepsia
|
It will be measured after 8 weeks
|
visual analogue scale
Time Frame: It will be measured after 8 weeks
|
It will be used to assess abdominal symptoms of geriatric patients regarding functional dyspepsia
|
It will be measured after 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ali MA Ismail, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 20, 2023
Primary Completion (Estimated)
January 30, 2024
Study Completion (Estimated)
January 30, 2024
Study Registration Dates
First Submitted
June 13, 2023
First Submitted That Met QC Criteria
June 13, 2023
First Posted (Actual)
June 23, 2023
Study Record Updates
Last Update Posted (Actual)
June 23, 2023
Last Update Submitted That Met QC Criteria
June 13, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/004557
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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