| CTRI Number |
CTRI/2024/07/069843 [Registered on: 03/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of effect of yoga on mental ability in stable long lasting airways diseases patients |
|
Scientific Title of Study
|
A study to assess the effect of yoga on cognitive functions in non hypoxemic stable Chronic Obstructive Pulmonary Disease (COPD) patients at RUHS-CMS and associated hospitals, Jaipur. |
| 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 Pratima Agrawal |
| Designation |
MD Resident |
| Affiliation |
Post Graduate resident ,RUHS-CMS,Jaipur |
| Address |
Department of Physiology, Rajasthan University of Health Sciences(RUHS), College of Medical Sciences(CMS),Sector 11,Kumbha Marg,Pratap Nagar,Tonk Road,Sanganer, Jaipur 302033(Rajasthan).
Jaipur
RAJASTHAN
302033
India |
| Phone |
9799981120 |
| Fax |
|
| Email |
priti1481@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Sudhanshu kacker |
| Designation |
Senior Professor |
| Affiliation |
Rajasthan University of Health Sciences(RUHS), College of Medical Sciences(CMS),Jaipur Rajasthan |
| Address |
Department of Physiology, Rajasthan University of Health Sciences(RUHS), College of Medical Sciences(CMS), Sector 11,Kumbha Marg, Pratap Nagar,Tonk Road,Sanganer, Jaipur 302033(Rajasthan) India
Department of Physiology, Rajasthan University of Health Sciences(RUHS), College of Medical Sciences(CMS), Sector 11,Kumbha Marg, Pratap Nagar,Tonk Road,Sanganer, Jaipur 302033(Rajasthan) India
Jaipur
RAJASTHAN
302033
India |
| Phone |
9983723535 |
| Fax |
|
| Email |
sudhanshukacker@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratima Agrawal |
| Designation |
MD Resident |
| Affiliation |
RUHS-CMS,Jaipur |
| Address |
Department of Physiology,Rajasthan University of Health Sciences(RUHS), College of Medical Sciences(CMS), Sector 11,Kumbha Marg, Pratap Nagar,Tonk Road,Sanganer, Jaipur 302033(Rajasthan) India
RAJASTHAN
302033
India |
| Phone |
9799981120 |
| Fax |
|
| Email |
priti1481@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajasthan University of Health Sciences(RUHS), College of Medical Sciences(CMS), Sector 11,Kumbha Marg, Pratap Nagar,Tonk Road,Sanganer, Jaipur 302033(Rajasthan) India |
|
|
Primary Sponsor
|
| Name |
Rajasthan University of Health SciencesRUHS College of Medical SciencesCMS Jaipur Rajasthan |
| Address |
Sector-11, Kumbha Marg,Pratap Nagar,Tonk Road,Sanganer,Jaipur302033 (Rajasthan) |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Pratima Agrawal |
Rajasthan University of Health Sciences(RUHS), College of Medical Sciences(CMS),Jaipur |
Department of Physiology Academic block 1st floor Rajasthan University of Health Sciences(RUHS), College of Medical Sciences(CMS), Sector 11,Kumbha Marg, Pratap Nagar,Tonk Road,Sanganer, Jaipur 302033(Rajasthan) India
Jaipur
RAJASTHAN |
9799981120
priti1481@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RUHS-CMS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, (2) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Yoga and asanas |
yoga and asanas for 45 mins,6 days a week for 6 month empty stomach will be advised Follow up will be done after baseline on 3 and 6 months. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Stable non hypoxemic COPD patients of 30 to 50 yrs of GOLD stage 1 & 2will be taken as case group and age matched healthy volunteer disease free of both sex will be taken as controll group. |
|
| ExclusionCriteria |
| Details |
Any pulmonary disease other than COPD
Any cardiovascular disease, hypertension diabetes,thyroid dysfunction
Any other systemic illness(musculoskeletal disorders like scoliosis kyphosis and neurological conditions)(by history)
Any psychological condition as Major Depression Bipolar disorder Obsessive Compulsive Disorder Generalized Anxiety Disorder and Schizophrenia
Patient with prior history of head injury cerebrovascular accident and epilepsy
History of chronic drug addiction and Alcohol
History of any traumatic lesion possibly affecting auditory functions as injury to tympanic membrane due to trauma loud noise barotrauma foreign body injuries or decrease hearing due to infection and injuries of middle ear |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ï¬To assess effect of yoga on cognitive functions (MMSE, MoCA and P300) in Non Hypoxemic stable Chronic Obstructive Pulmonary Disease (COPD) patients at RUHS-CMS and associated Hospitals (RDBP Jaipuria and RUHS), Jaipur |
assessment at baseline and after 3 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| effect of yoga on spirometric indices,study & correlation between Mini Mental State Examination score, Montreal Cognitive Assessment score & Event Related Potential latency & amplitude. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
14/07/2024 |
| 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
|
I’m recruiting my stable COPD patients who are of GOLD stage 1 &2 from medicine opd or RUHS -CMS and from RDBP jaipuria Hospital from medicine OPD. After recruitment performa about their socio-demographic status, Anthropometric parameter, vitals are to be filled. Stages of COPD we are confirming by doing spirometry at our deparment clinical lab.after confirmation of stage we are checking cognition by MoCA, MMSE questionare and Event Related Potential.Then these Patients are being advised for 6 month yoga for 45 mins 6 days a week. Comparision of cases will be done by age matched healthy volunteers, Spirometry, MMSE, MoCA, ERPwill also be done in control group but without intervention.Follow up will be done at 3 and 6 month after yoga. |