| CTRI Number |
CTRI/2023/08/056187 [Registered on: 07/08/2023] Trial Registered Prospectively |
| Last Modified On: |
04/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Immediate effect of Kaphalabhati and Chandra Anuloma Viloma Pranayama to measure the Cardiovascular Health in Healthy Individuals |
|
Scientific Title of Study
|
Immediate Effect Of Left Nostril breathing and skull shining breath to evaluate the Cardiovascular Competence In Healthy Individuals-A Comparative Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SATHIYAN J |
| Designation |
INTERN |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF NATUROPATHY AND YOGIC SCIENCES |
| Address |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF NATUROPATHY AND YOGIC SCIENCES UJIRE BELTHANGADY TALUK DAKSHINA KANNADA KARNATAKA
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9606207642 |
| Fax |
|
| Email |
sathiyan22.dr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHASHIKIRAN H C |
| Designation |
Dean division of Research Methodologies and Deputy Medical Superintendent |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF NATUROPATHY AND YOGIC SCIENCES |
| Address |
SRI DHARMASTHALA MANJUNATHESHWARA NATURE CURE HOSPITAL SHANTHIVANA DHARMASTHALA BELTHANGADY TALUK DAKSHINA KANNADA KARNATAKA
Dakshina Kannada
KARNATAKA
574216
India |
| Phone |
9483004440 |
| Fax |
|
| Email |
bnysresearch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHASHIKIRAN H C |
| Designation |
Dean division of Research Methodologies and Deputy Medical Superintendent |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF NATUROPATHY AND YOGIC SCIENCES |
| Address |
SRI DHARMASTHALA MANJUNATHESHWARA NATURE CURE HOSPITAL SHANTHIVANA DHARMASTHALA BELTHANGADY TALUK DAKSHINA KANNADA KARNATAKA
Dakshina Kannada
KARNATAKA
574216
India |
| Phone |
9483004440 |
| Fax |
|
| Email |
bnysresearch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara Yoga and Nature cure hospital Shantivana Dharmasthala Dakshina Kannada |
|
|
Primary Sponsor
|
| Name |
SATHIYAN J |
| Address |
SDM College of naturopathy and yogic sciences Ujire Belthangady Dakshina Kannada 574240 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Sathiyan J |
SRI DHARMASTHALA MANJUNATHESWARA NATURE CURE HOSPITAL SHANTIVANA DHARMASTHALA |
Department of Yoga Shantivana Dharmasthala Dakshina Kannada
574216
Dakshina Kannada
KARNATAKA |
9606207642
sathiyan22.dr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara College Of Naturopathy and Yogic Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Kapalbhati kriya |
The immediate effects of Kapalabhathi kriya was evaluated by performing 5 rounds, each consisting of 30 strokes, resulting in a total of 150 strokes within a duration of 3 minutes. |
| Intervention |
Kapalbhati kriya and Chandra anuloma viloma pranayama |
The immediate effects of Kapalabhathi kriya was evaluated by performing 5 rounds, each consisting of 30 strokes, resulting in a total of 150 strokes within a duration of 3 minutes.
It was followed by the practice of Chandra anuloma-viloma pranayama performed for a duration of 3 minutes, with 3 rounds of 9 cycles each. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
27.00 Year(s) |
| Gender |
Both |
| Details |
No other systemic diseases
No underlined cognitive disorder
Willing to participate in the trial by signing an informed consent.
|
|
| ExclusionCriteria |
| Details |
Subjects with health problems like cognitive impairment, psychological disorders or any systemic ailments will be excluded
Individual consuming alcohol and nicotine.
Pregnancy and lactation.
People under any medications.
People who aged more than 27 years and under 18 years
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate Pressure Product |
Baseline,1 minute 3 minute and 5 minute |
|
|
Secondary Outcome
|
|
|
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 3 |
|
Date of First Enrollment (India)
|
15/08/2023 |
| 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="0"
Months="2"
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
|
A
prior permission will be obtained regarding the ethical issue from the college
for conducting the study. The subjects will be considered for the study after
screening as per the demands of inclusion and exclusion criteria. An informed
consent will be obtained from the subjects by explaining the study objectives,
methods, intervention and all the rights of the subject pertaining to the study
both orally and in writing. The participants will undergo the supervised training of kapalbhati
pranayama and Chandra anuloma viloma pranayama prior to the study. They were
directed to sit in an easy and steady posture either in a lotus posture i.e.,
Padmasana or a comfortable sitting posture i.e., Sukhasana) with the head, neck
and trunk erect and in a straight line and keep the body still during practice
of pranayama in a calm and quiet room. |