| CTRI Number |
CTRI/2022/07/044446 [Registered on: 28/07/2022] Trial Registered Prospectively |
| Last Modified On: |
31/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To examine the selected physical & psychological effects of laghu shankhaprakshalana kriya (yogic gut cleansing practice) in healthy people
|
|
Scientific Title of Study
|
Effect of Laghu Shankhaprakshalana Kriya (Yogic Gastrointestinal Cleansing) on Body Composition, Interoceptive Awareness and Selected Physiological Parameters in Healthy Adults
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jaydeep Negi |
| Designation |
PhD scholar |
| Affiliation |
University Of Patanjali, Haridwar |
| Address |
Department of Yoga Science, University Of Patanjali
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9927938473 |
| Fax |
|
| Email |
negi.jaydeep@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Kumar Bhardwaj |
| Designation |
Assistant Professor |
| Affiliation |
University Of Patanjali, Haridwar |
| Address |
University Of Patanjali, Haridwar, Uttarakhand
Patanjali Yogpeeth Phase 1, Haridwar, Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7906023622 |
| Fax |
|
| Email |
abhishek@uop.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Jaydeep Negi |
| Designation |
PhD scholar |
| Affiliation |
University Of Patanjali |
| Address |
Department of Yoga Science, University Of Patanjali
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7017273009 |
| Fax |
|
| Email |
negi.jaydeep@gmail.com |
|
|
Source of Monetary or Material Support
|
| Garden Valley Public School, Ramnagar, Nainital, Uttarakhand |
|
|
Primary Sponsor
|
| Name |
University Of Patanjali |
| Address |
University Of Patanjali, Haridwar, Uttarakhand |
| Type of Sponsor |
Other [Private University] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Jaydeep Negi |
University Of Patanjali, Haridwar, Uttarakhand |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kripal Singh Mehra |
Garden Valley Public School |
Yoga hall, Gaujani, Ramnagar
Nainital
UTTARANCHAL |
8077313210
gvpsmehra@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee University Of Patanjali |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Overweight, Constipation and general psychological disorder |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
No intervention will be given |
| Intervention |
Laghu Shankhaprakshalana Kriya (Yogic Gastrointestinal Cleansing) |
The experimental group will undergo LSP for 2 months once a week (total 8 LSP sessions), early morning on an empty stomach
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
Normal healthy males, naive to yoga, age group between 20 and 40 years.
Those who are willing to follow the study protocol. |
|
| ExclusionCriteria |
| Details |
Participants having any medical condition or any systemic illness.
Weak and debilitating individuals
Underweight persons (BMI< 18.5)
Those who are taking drugs, alcohol and any other intoxicants. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Body Composition Analysis, Interoceptive Awareness and Gastric Interoception |
before and after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood pressure, Anthropometric measurements, Constipation score, Appetite assessment, General-well being |
before and after intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2022 |
| Date of Study Completion (India) |
15/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
We are doing a doctoral research on the effect of Laghu Shankhaprakshalana Kriya (LSP) on body composition, interoceptive awareness and selected physiological parameters in healthy adults. LSP is a yoga-based cleansing practice which involves drinking lukewarm saltwater in combination with dynamic yoga Äsanas that leads to the cleansing of the entire alimentary canal. Randomly selected participants will be divided into two groups with 30 subjects in both (i) experimental group (ii) control group. The experimental group will undergo LSP for 2 months once a week (total 8 LSP sessions), early morning on an empty stomach and on the other side control group will be remain without intervention. Pre and post intervention data collection will be done.
|