| CTRI Number |
CTRI/2012/09/002977 [Registered on: 10/09/2012] Trial Registered Retrospectively |
| Last Modified On: |
10/09/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
a comparative study between slow ,fast pranayams and control groups on pulmonary function and hand grip strength and endurance in normal individulas |
|
Scientific Title of Study
|
Effect of slow and fast pranayams on pulmonary function, hand grip strength and endurance in young, healthy volunteers- a randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SEC/2011/1/6 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dinesh T |
| Designation |
Junior Resident |
| Affiliation |
JIPMER, PUDUCHERRY |
| Address |
Department of Physiology
Jipmer
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9788964910 |
| Fax |
|
| Email |
sclerombbs@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Kumar Sharma |
| Designation |
Assistant Professor |
| Affiliation |
JIPMER, PUDUCHERRY |
| Address |
Department of Physiology
JIPMER
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9442529673 |
| Fax |
|
| Email |
drviveksharma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madanmohan Trakroo |
| Designation |
Professor & Head |
| Affiliation |
Sri Balaji vidyapeet university (deemed) |
| Address |
Mahatma Gandhi Medical College and Research Institute
Pillaiyarkuppam
Pondicherry
PONDICHERRY
607 402
India |
| Phone |
|
| Fax |
|
| Email |
drmadanmohan999@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER institution, Pondicherry |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
JAWAHARLAL POSTGRADUATE MEDICAL EDUCATION AND RESEARCH
DHANVANTRI NAGAR
PNDICHERRY |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vivek Kumar Sharma |
JIPMER campus , other colleges in and around pondicherry |
Dhanvantri nagar
Gorimedu
pondicherry
Pondicherry
PONDICHERRY |
9442529673
drviveksharma@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee / Subcommittee (Human studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
normal, healthy volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
"slow pranayam, fast pranayam"
|
I Slow pranayam: nadishodhana, savitri pranayam and pranav pranayam on alternate days, daily 20 mins for 12 weeks
II Fast pranayam : kapalabhati, bhastrika and kukkuriya pranayam on alternate days, daily 20 mins for 12 weeks
|
| Comparator Agent |
control group |
without any intervention, pre and post values |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Young healthy volunteers.
2. No history of chronic respiratory illness
|
|
| ExclusionCriteria |
| Details |
1. Smokers.
2. Alcoholics.
3. Subjects currently on medication.
4. Previous experience of yoga training.
5. Athletes
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the pulmonary function parameters,hand grip strength and endurance |
0 weeks & 12 weeks of study period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of pranayam and type of pranayam which will be more useful for the improvement of pulmonary function and hand grip strength and endurance |
0 weeks and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
105 young healthy volunteers were recruited for the study and they were randomly allocated into slow pranayam group (N=30) ( nadishodhana, savitri pranayam and pranav pranayam) , fast pranayam group (kapalabhati, bhastrika and kukkuriya pranayam) (n=30) and control group (n=30) respectively. Basal pulmonary function parameters and hand grip strength and endurance were recorded at the start of study and subjects were given Pranayam training by trained, certified toga teachers in the Advanced Centre for Yoga Therapy Education and Research (ACYTER), JIPMER. Post values were taken at end of 12 weeks study period. Parameters were compared between slow and fast pranayams and with pranayam groups and control group.
|