| CTRI Number |
CTRI/2025/02/081327 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Suryanamaskar with and without Mantras on Reducing Stress in College Students |
|
Scientific Title of Study
|
A Comparative clinical study to assess the efficacy of Suryanamaskar with Mantra and Suryanamaskar without Mantra in alleviating stress levels in degree college students with reference to Sharira Prakruti. |
| 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 Chaudhary Mohd Rayees Mohd Halim |
| Designation |
PG Scholar (Kriya Sharir) |
| Affiliation |
D Y Patil University, School of Ayurveda Nerul, Navi Mumbai |
| Address |
Department of Kriya Sharir, D Y Patil School of
Ayurveda Deemed to be University, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India
Thane MAHARASHTRA 400706 India |
| Phone |
7977394048 |
| Fax |
|
| Email |
rayeeschaudhary986722@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Hemangini Waghulade |
| Designation |
Professor and HoD |
| Affiliation |
D Y Patil School of Ayurveda |
| Address |
Department of Kriya Sharir, D Y Patil School of
Ayurveda Deemed to be University, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
Thane MAHARASHTRA 400706 India |
| Phone |
8108518452 |
| Fax |
|
| Email |
hemangini.waghulade@dypatil.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Hemangini Waghulade |
| Designation |
Professor and HoD |
| Affiliation |
D Y Patil School of Ayurveda |
| Address |
Department of Kriya Sharir, D Y Patil School of
Ayurveda Deemed to be University, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
Thane MAHARASHTRA 400706 India |
| Phone |
8108518452 |
| Fax |
|
| Email |
hemangini.waghulade@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| DY Patil Deemed to be University School of Ayurveda, Nerul, Navi Mumbai-400706, India |
|
|
Primary Sponsor
|
| Name |
DY Patil Deemed to be University School of Ayurveda, Nerul, Navi Mumbai-400706, India |
| Address |
DY Patil Deemed to be University School of Ayurveda, Nerul, Navi Mumbai-400706, India |
| 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 Hemangini Waghulade |
DY Patil School of Ayurveda |
Room No. 1, Dept of Kriya Sharira, Second Floor, D. Y. Patil deemed to be University School of Ayurveda, Thane, MAHARASHTRA Thane MAHARASHTRA |
8108518452
hemangini.waghulade@dypatil.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of DY Patil Deemed to be University, School of Ayurveda, Nerul |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
College Students, Age-18-25 years |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Suryanamaskara along with Mantra Chikitsa | (Procedure Reference: Hatha Yoga pradipika, Procedure details: Surya Namaskar will be conducted as a series of 12 asanas comprising 24 steps in total,
constituting one round. Both groups will be subjected to 8-10 sets of Surya Namaskar in
morning before breakfast around 7 a.m. in online mode for 10 weeks .This procedure
will be conducted for at least 5 days in a week i.e. minimum 20 sessions per month.)
| | 2 | Comparator Arm | Procedure | - | Suryanamaskara | (Procedure Reference: Hatha Yoga pradipika, Procedure details: Surya Namaskar will be conducted as a series of 12 asanas comprising 24 steps in total,
constituting one round. Both groups will be subjected to 8-10 sets of Surya Namaskar in
morning before breakfast around 7 a.m. in online mode for 10 weeks .This procedure
will be conducted for at least 5 days in a week i.e. minimum 20 sessions per month.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Community-Indian
Subjects ready to abide by trial procedure and to give informed consent.
e. Students categorized in mild (40-80) and moderate (80-121) stress level groups
according to SSI scale.
|
|
| ExclusionCriteria |
| Details |
a. Subjects having any acute or chronic disease or any type of mental illness.
b. Students who are performing Surya Namaskar regularly.
c. Students categorized in high score (122 - 160) stress level groups according to SSI scale
as they require proper counseling. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
There is significant difference between efficacy of Surya Namaskar
with in alleviating stress levels in Degree college students. |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
There is significant difference between efficacy of Surya Namaskar
with and without mantra in alleviating stress levels in sharir prakruti of Degree college students. |
90 days |
|
|
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)
|
11/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Summary: Stress among college students has become a major health concern, particularly due to academic pressures and the competitive environment. Stress levels among Indian students are reported to range from 30-60%, often manifesting as sleeplessness, anxiety, and somatic symptoms during high-intensity study periods. Ayurveda links stress to various health issues, such as immune system depletion, and describes it as "Sahasa," with different stressors contributing to health problems. Surya Namaskar, a traditional yogic practice involving physical postures and mantras, has been shown to reduce stress and improve cardiovascular health. However, the comparative effectiveness of Surya Namaskar with and without mantras has not been fully explored, particularly from an Ayurvedic perspective. Ayurveda suggests that different Prakruti (body constitution) types, based on dosha predominance, experience stress differently, with Vata and Pitta types being more prone to stress. This study aims to compare the effects of Surya Namaskar with and without mantras on stress levels in college students, considering their unique Prakruti types. The study is an open-labeled, randomized controlled trial with 60 college students, aged 18-25, categorized based on their stress levels. Thirty students will practice Surya Namaskar with mantras, while the other thirty will perform the physical postures without mantras. The effectiveness of these practices will be evaluated using stress assessment tools, and the study will be conducted over a period of 3 months. The study aims to determine whether Surya Namaskar with mantras has a greater impact on stress reduction compared to the physical sequence alone, considering individual Prakruti types. The hypothesis is that there will be a significant difference in the efficacy of Surya Namaskar with and without mantras in alleviating stress. The study will provide insights into personalized stress management approaches based on Ayurvedic principles. |