| CTRI Number |
CTRI/2023/07/055733 [Registered on: 26/07/2023] Trial Registered Prospectively |
| Last Modified On: |
05/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Yogasana & Praṇayama for Cardiopulmonary Health |
|
Scientific Title of Study
|
Effect of Yogasana & Praṇayama on Cardiopulmonary functions on Sawmill, Sugar cane & Bidi workers in the rural sector |
| Trial Acronym |
Role of Yogasana and Pranayama on Cardiopulmonary functions among Sawmill, Sugar cane and Bidi workers |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Milind Abhimanyu Nisargandha |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Physiology
Jawaharlal Nehru Medical College Sawangi (M) Wardha
Department of Physiology
Jawaharlal Nehru Medical College Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9423276429 |
| Fax |
07152287701 |
| Email |
manisargandha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Milind Abhimanyu Nisargandha |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Physiology
Jawaharlal Nehru Medical College Sawangi (M) Wardha
Department of Physiology
Jawaharlal Nehru Medical College Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9423276429 |
| Fax |
07152287701 |
| Email |
manisargandha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Dadarao Parwe |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved College and Hospital Research Centre, DMIHER |
| Address |
Department of Panchakarma
Mahatma Gandhi Ayurved College and Hospital Research Centre
Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9403142270 |
| Fax |
|
| Email |
drshwetaparve@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha |
| Type of Sponsor |
Private 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 |
| Milind Abhimanyu Nisargandha |
Jawaharlal Nehru Medical College |
Department of Physiology, JNMC Building Sawangi
Wardha
MAHARASHTRA |
9423276429
manisargandha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee, Datta Meghe Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cardiopulmonary Functions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Yogasana and Pranayama |
In Healthy Human Volunteers Halasana (Plough), Akarna-dhanurasana (Reverse Bow Posture), Ardh-matsyendrasana (Half spine twist), Ushtrasana (Camel), Bhujangasana (Cobra), Surya namaskar(Sun salute). Praṇayama- Pranayama is the Yogic breathing technique, Unilateral nostril breathing, Alternate nostril breathing, Kapalbhati, Bhastrika, and Bhramari Pranayama. subjects will be trained by a Yoga teacher through some specific Asana and Pranayama. They will be instructed to perform for 20 weeks under the supervision of a yoga teacher. |
| Intervention |
Yogasana and Pranayama |
Halasana (Plough), Akarna-dhanurasana (Reverse Bow Posture), Ardh-matsyendrasana (Half spine twist), Ushtrasana (Camel), Bhujangasana (Cobra), Surya namaskar(Sun salute).
Praṇayama- Pranayama is the Yogic breathing technique, Unilateral nostril breathing, Alternate nostril breathing, Kapalbhati, Bhastrika, and Bhramari Pranayama.
subjects will be trained by a Yoga teacher through some specific Asana and Pranayama. They will be instructed to perform for 20 weeks under the supervision of a yoga teacher
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Sawmill, Sugar cane, and Bidi workers aged between 20 - 40yrs
2. Minimum Exposures of 5 yrs and above.
3. Those who have respiratory symptoms like breathlessness and cough.
|
|
| ExclusionCriteria |
| Details |
1. Sawmill, Sugar cane, and Bidi workers between 20yrs to 40yrs
2. Sawmill, Sugar cane, and Bidi workers not exposed <5 yrs
3. Bidi workers who are bidi smokers (Confounder)
4. Sawmill, Sugar cane, and Bidi workers with HTN, Metabolic disorders, and Congenital anomaly in cardio-respiration.
5. Addicted to alcohol.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| yoga asana & Pranayama positively affected the cardiopulmonary functions of the sawmill sugar cane bidi workers in the rural sector. The workers showed significant improvement in their lung capacity oxygen saturation levels heart rate variability after regular practice of yoga asana and Pranayama |
After 20 weeks of training their parameters will be assessed |
|
|
Secondary Outcome
|
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
12/09/2023 |
| 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="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
|
The rural sector is an essential component of any country’s
economy, and it is characterized by a large number of workers involved in
various activities such as agriculture, forestry, and small-scale industries. Sawmills,
sugar cane, and bidi workers are among the workers in the rural sector who are
frequently exposed to hazardous working conditions that can negatively impact
their health. These workers are at a higher risk of developing respiratory and
cardiovascular diseases due to prolonged exposure to dust, smoke, and other
harmful substances. This study aimed to evaluate the effect of yoga asana and Pranayama
on cardiopulmonary functions in sawmills, sugar cane, and bidi workers in the
rural sector. 120 workers were randomly assigned to a yoga
or control group. The yoga group underwent a 12-week program of yogasana and Pranayama,
while the control group continued their usual activities. Cardiopulmonary
functions were assessed at baseline and after the intervention using
spirometry, peak expiratory flow rate, and pulse oximetry. The
results may show that the yoga & pranayama group significantly improved
spirometry parameters, peak expiratory flow rate, and pulse oximetry readings
compared to the control group. |