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CTRI Number  CTRI/2025/05/087589 [Registered on: 26/05/2025] Trial Registered Prospectively
Last Modified On: 24/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Combined Effect of an upright posture, Structured Exercises on Indigestion in Young population: A Randomised Clinical Trial 
Scientific Title of Study   Combined Effect of an upright posture, Structured Exercises on Functional Dyspepsia in Young population: A Randomised Clinical Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Varsha Huddar 
Designation  ASSISTANT PROFESSOR 
Affiliation  KLE INSTITUE OF PHYSIOTHERAPY 
Address  K.L.E.S Prabhakar Kore Hospital and Medical Research centre, Sagar Floor, Advanced Physiotherapy Centre, Biomechanics department Room no 2, OPD no.39, Nehru Nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9880733370  
Fax    
Email  varshahuddar@klekipt.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Varsha Huddar 
Designation  ASSISTANT PROFESSOR 
Affiliation  KLE INSTITUE OF PHYSIOTHERAPY 
Address  K.L.E.S Prabhakar Kore Hospital and Medical Research centre, Sagar Floor, Advanced Physiotherapy Centre, Biomechanics department Room no. 2, OPD no.39, Nehru Nagar.

Belgaum
KARNATAKA
590010
India 
Phone  9880733370  
Fax    
Email  varshahuddar@klekipt.edu.in  
 
Details of Contact Person
Public Query  
Name  Arya Kasar 
Designation  Physiotherapy Intern 
Affiliation  KLE INSTITUE OF PHYSIOTHERAPY 
Address  K.L.E.S Prabhakar Kore Hospital and Medical Research Centre, Sagar Floor, Advanced Physiotherapy Centre, room no. 3, Biomechanics department OPD no.39, Nehru Nagar

Belgaum
KARNATAKA
590010
India 
Phone  9529466255  
Fax    
Email  aryakasar2t@gmail.com  
 
Source of Monetary or Material Support  
KLE Dr Prabhakar Kore Hospital and Research Centre, Nehru Nagar, Sagar floor (-1). Belgaum 
 
Primary Sponsor  
Name  KAHER institute of Physiotherapy 
Address  KAHER Institute of Physiotherapy, Nehru Nagar,Belgavi- 590010, Karnataka 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Varsha Huddar  KAHER Institute of Physiotherapy  K.L.E.S Prabhakar Kore Hospital and Medical Research centre, Sagar Floor, room no. 3. Advanced Physiotherapy Centre, Biomechanics department OPD no.39, Nehru Nagar, Belgavi
Belgaum
KARNATAKA 		 9880733370

varshahuddar@klekipt.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethical Committee of KAHER Institute of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Functional Dyspepsia  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  diet  This diet chart will be given for 4 weeks in which group A will receive diet and group B will receive upright posture and structured exercises 
Intervention  structured exercises  This intervention will be given for 4 weeks for 5 consecutive days in which group A will receive diet and group B will receive upright posture and structured exercises  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  26.00 Year(s)
Gender  Both 
Details  1. All genders between 18-26 years of age
2. Participants willing to participate in the study
3. Participants diagnosed with functional dyspepsia by dietician
4. Participants ready to adhered to the diet plan 
 
ExclusionCriteria 
Details  1. Any diagnosed cases, such as systemic illness or such as abdominal or spinal surgeries, wherein patient is not able to maintain upright posture
2. Patient suffering from cancer or any other disease (or mimicking symptoms of dyspepsia)
3. Participants with any spinal abnormality or any spinal fractures, hampering the postures Patients unwilling to participate or following any other diet plan or with any existing medications 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
SF- 36 LEEDS DYSPEPSIA QUESTIONNARIE   day 1 and day 28  
 
Secondary Outcome  
Outcome  TimePoints 
Diet  day 1 to day 28 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  08/08/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included varshahuddar@klekipt.edu.in).

  6. For how long will this data be available start date provided 16-05-2025 and end date provided 30-08-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This randomized clinical trial aims to evaluate the combined effect of upright posture and structured exercises on functional dyspepsia in young adults aged 18–26. Functional dyspepsia, a common digestive disorder without an identifiable cause, is linked to poor posture and physical inactivity. The study divides participants into two groups—one receiving dietary modifications and the other undergoing posture correction and exercise therapy. Outcomes will be measured using the Short-Form Leeds Dyspepsia Questionnaire to determine symptom improvement after four weeks. This non-pharmacological approach may offer a simple, sustainable method for managing dyspeptic symptoms. 
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