| CTRI Number |
CTRI/2024/02/063269 [Registered on: 28/02/2024] Trial Registered Prospectively |
| Last Modified On: |
22/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Yoga Protocol on patients with respiratory disorder |
|
Scientific Title of Study
|
EFFECTS OF SHORT-TAILORED YOGA PROTOCOL ON PSYCHO-BIOCHEMICAL PARAMETERS OVER CHRONIC
OBSTRUCTIVE PULMONARY DISEASE 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 |
Dr KHUSHBU JAIN |
| Designation |
Assistant Professor (Biochemistry) |
| Affiliation |
MORARJI DESAI NATIONAL INSTITUTE OF YOGA |
| Address |
DEPARTMENT OF ALLIED SCIENCES MORARJI DESAI NATIONAL INSTITUTE OF YOGA 68 ASHOKA ROAD
68 ASHOKA ROAD DELHI
Central
DELHI
110001
India |
| Phone |
9711506919 |
| Fax |
|
| Email |
khushbu.nano@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KHUSHBU JAIN |
| Designation |
Assistant Professor (Biochemistry) |
| Affiliation |
MORARJI DESAI NATIONAL INSTITUTE OF YOGA |
| Address |
DEPARTMENT OF ALLIED SCIENCES MORARJI DESAI NATIONAL INSTITUTE OF YOGA 68 ASHOKA ROAD
68 ASHOKA ROAD DELHI
Central
DELHI
110001
India |
| Phone |
9711506919 |
| Fax |
|
| Email |
khushbu.nano@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Megha Kpaur |
| Designation |
MSc Student |
| Affiliation |
Morarji Desai National Institute of Yoga |
| Address |
MORARJI DESAI NATIONAL INSTITUTE OF YOGA 68 ASHOKA ROAD
68 ASHOKA ROAD
Central
DELHI
110001
India |
| Phone |
7300078650 |
| Fax |
|
| Email |
mdniyresearch@gmail.com |
|
|
Source of Monetary or Material Support
|
| MORARJI DESAI NATIONAL INSTITUTE OF YOGA MINISTRY OF AYUSH GOVT. OF INDIA 68 ASHOKA ROAD |
|
|
Primary Sponsor
|
| Name |
MORARJI DESAI NATIONAL INSTITUTE OF YOGA |
| Address |
DIRECTOR, MDNIY, 68 ASHOKA ROAD DELHI-110001 |
| Type of Sponsor |
Other [Government National Institute] |
|
|
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 KHUSHBU JAIN |
BIOCHEMISTRY LABORATORY, DEPARTMENT OF ALLIED SCIENCES, MORARJI DESAI NATIONAL INSTITUTE OF YOGA |
MINISTRY OF AYUSH GOVT. OF INDIA 68 ASHOKA ROAD DELHI
Central
DELHI |
9711506919
khushbu.nano@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL 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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No intervention only medication prescibed by allopathy doctors |
no intervention |
| Intervention |
Short tailored Yoga protocol
duration 20 minutes
Routine allopathy medicine continued |
1 Suksma vyayama (vakshashtal Shakti vikasak 1and 2) 2 minutes 4 each
1 Ujjai Pranayama
With jnana mudra, Pranav mudra and sukh asana 5 minutes 5
2 Bhramari pranayama with yoni mudra and sukh asana 5 minutes 5
3 Linga Mudra
With sukh asana and yam mantra 4 minutes 1
4 Anupreksha dhyaan with sukh asana 4 minutes 1
5 Kunjal kirya
(optional) Once a week 1
Total duration of session 20 minutes
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
COPD patient (mild and moderate condition)
on allopathy medication
able to perform yoga practices
no comorbidity
Able to read and write questionnaires/can participate in assessments |
|
| ExclusionCriteria |
| Details |
COPD patient (severe condition)
not able to perform yoga practices
with comorbidity
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Short tailore yoga protocol may help in improving the clinical/biochemical symptoms in COPD patients |
base line pre intervention data at 0 day and endline post intervention data on completion of 1 month intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Short tailore yoga protocol may help in improving quality of life and reducing fatigue in COPD patients |
base line pre intervention data at 0 day and endline post intervention data on completion of 1 month intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| 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="0"
Months="6"
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 - NO
|
|
Brief Summary
|
COPD being a chronic ailment has expensive treatment options which has significant side effects, yoga acts as a rather cost effective, easy to implement practice which can be prescribed to patients with mild and moderate conditions by providing a short-tailored yoga protocol, we are providing an immediate intervention to manage the symptoms of the patient. The research proposal is a Randomized controlled, clinical trial with single blinded condition. The patients will be grouped into two categories of experimental/with yogic intervention group and control without intervention group. The short tailored yoga protocol is of 20 minutes duration will be administered for 1 month to experimental group with data collection at pre intervention and post intervention level. The parameters respiratory rate, pulse rate, oxygen saturation, lung capacity fatigue assesment , dyspnea assessment, exercise tolerance, serum cytokines, oxidative stress and quality of life will be assessed.
|