| CTRI Number |
CTRI/2024/08/072193 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Pulmonary rehabilitation & vitamin D on Asthma |
|
Scientific Title of Study
|
Combined effect of vitamin D supplementation & Pulmonary Rehabilitation on asthma patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof.Dr Rahul Saxena |
| Designation |
Professor |
| Affiliation |
sharda university |
| Address |
5th floor Department of Physiotherapy, Sharda University campus plot no 32 Knowledge park III Greater Noida
5th floor Department of Physiotherapy, Sharda University campus plot no 32 Knowledge park III Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9958255816 |
| Fax |
|
| Email |
rahul.saxena@sharda.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
profDr Rahul Saxena |
| Designation |
professor |
| Affiliation |
sharda university |
| Address |
5th floor Department of Physiotherapy, Sharda University campus plot no 32 Knowledge park III Greater Noida
5th floor Department of Physiotherapy, Sharda University campus plot no 32 Knowledge park III Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9958255816 |
| Fax |
|
| Email |
rahul.saxena@sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Ambreen Fatima |
| Designation |
PhD Scholar |
| Affiliation |
sharda university |
| Address |
5th floor Department of Physiotherapy, Sharda University campus plot no 32 Knowledge park III Greater Noida
5th floor Department of Physiotherapy, Sharda University campus plot no 32 Knowledge park III Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9760084221 |
| Fax |
|
| Email |
ambreen.fatima33@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SHARDA UNIVERSITY |
| Address |
Plot No. 32, 34, Knowledge Park III, Greater Noida, Uttar Pradesh 201306 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| ProfDrRahul Saxena |
Sharda University research and Development Cell |
Sharda University Campus, Plot No. 32, 34, Knowledge Park III, Greater Noida, Uttar Pradesh 201306 Gautam Buddha Nagar UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH |
9958255816
rahul.saxena@sharda.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ELISA kit method
for 4 to 6 weeks |
Serum CRP
Serum IL-6
Serum TNF-α
|
| Intervention |
PULMONARY FUNCTION TEST (PFT) |
4 to 6 weeks Spirometry: Pulmonary function testing involves the measurement of air flow dynamics during respiratory manoeuvres, providing information on the amount and speed of air entering and leaving the lungs.
FVC forced vital capacity
Forced expiratory volume in 1 second (fev1):
The ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) is used to determine whether an individuals respiratory pattern is obstructive, restrictive, or within the normal range.
PEF (peak expiratory flow)
|
| Comparator Agent |
vitaminD & pulmonary rehabilitation group |
4 to 6 weeks intervention will be given to the Patients who will be ready to provide informed consent Patients with mild & moderate Asthma Low vitamin D level as per American association of endocrinologists(less than30ng/ml) Receiving pulmonary rehabilitation along with vitamin D supplementation. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients who will be ready to provide informed consent Patients with mild & moderate Asthma Low vitamin D level as per American association of endocrinologists(less than30ng/ml) Receiving prescribed medication by physician |
|
| ExclusionCriteria |
| Details |
Smokers or patients suffering : hypothyroidism, liver or kidney diseases, cardiovascular disease, History of familial dyslipidemia, acute & chronic infections, fever, & malignancy
Severe stage asthma patients
Patients less than 30 & more than 55 years |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hospital Anxiety and Depression Scale. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SGRQ |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
This study is taken up to see the effect of vitamin D supplementation along with pulmonary rehabilitation on Asthma patients in Delhi NCR region. A sample of 200 patients, who will meet inclusion criteria will be participated to be apart of study100 subjects will be in controlled group 1 & 100 subjects will be ingroup 2 Consent form will be taken and pre- test measures will be done. Pulmonary Rehabilitation for 4 -6 weeks will be given which include general breathing exercises. The patients in PR group will attend a structured, comprehensive PR program for six weeks. This PR program will be institution based; therefore, the entire exercise protocol will be performed under the supervision of a qualified physiotherapist at the hospital .The PR program comprised of stretching of upper and lower extremity muscles, breathing exercises,self-management, and patient education. Breathing exercises will last for 30 minutes in each session and will performed two-to-thee times per week for six weeks. Diaphragmatic and pursedlip breathing will be performed |