FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/078548 [Registered on: 24/12/2024] Trial Registered Prospectively
Last Modified On: 24/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Other 
Public Title of Study   Effect of Bhraamaree Praanaayaama on pre- exam stress in students 
Scientific Title of Study   An open labelled two-armed randomised controlled trial to evaluate effect of Bhraamaree praanaayaama on pre- exam stress in students preparing for National Eligibility-cum-Entrance Test (NEET)  
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 Pallavi Dattatray Nikam 
Designation  Ph.D. Scholar 
Affiliation  Shri Ayurved Mahavidyalaya, Nagpur  
Address  C/O Department of Kayachikitsa, Shri Ayurved Mahavidyalaya,
Hanuman Nagar, Dhanvantari Road,
Nagpur
MAHARASHTRA
440009
India 
Phone  8454844613  
Fax    
Email  dr.pallavinikam@yahoo.in  
 
Details of Contact Person
Scientific Query  
Name  Dr. Archana Sudarshan Dachewar 
Designation  Professor and H.O.D., Department of Kayachikitsa 
Affiliation  Shri Ayurved Mahavidyalaya, Nagpur  
Address  C/O Department of Kayachikitsa, Shri Ayurved Mahavidyalaya,
Hanuman Nagar, Dhanvantari Road,
Nagpur
MAHARASHTRA
440009
India 
Phone  8454844613  
Fax    
Email  dr.dachewar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pallavi Dattatray Nikam 
Designation  Ph.D. Scholar 
Affiliation  Shri Ayurved Mahavidyalaya, Nagpur  
Address  C/O Department of Kayachikitsa, Shri Ayurved Mahavidyalaya,
Hanuman Nagar, Dhanvantari Road,
Nagpur
MAHARASHTRA
440009
India 
Phone  8454844613  
Fax    
Email  dr.pallavinikam@yahoo.in  
 
Source of Monetary or Material Support  
Shri Ayurved Mahavidyalaya, Hanuman Nagar, Dhanvantari Road, Nagpur, Maharashtra, India - 440024 
 
Primary Sponsor  
Name  Dr. Pallavi Dattatray Nikam 
Address  PhD Scholar (Yoga), Shri Ayurved Mahavidyalaya, Hanuman Nagar, Dhanvantari Road, Nagpur- 440009 
Type of Sponsor  Other [Self sponsored] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pallavi Dattatray Nikam  O.P.D. of Dept of Swasthavritta and Yoga, Matoshri Ayurved Hospital,   Eklahare, Near Odhagaon, Nashik
Nashik
MAHARASHTRA 		 8454844613

dr.pallavinikam@yahoo.in 
Dr Pallavi Dattatray Nikam  O.P.D. of Dept. Of Kayachikitsa, Shri Ayurved Mahavidyalaya Hospital  Hanuman Nagar, Dhanvantari Road, Nagpur
Nagpur
MAHARASHTRA 		 8454844613

dr.pallavinikam@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee of Matoshri AD Ayurved College  Approved 
Institutional Ethics Committee of Shri Ayurved Mahavidyalaya  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Students going to appear for NEET for the first time and having mild to moderate stress trait anxiety as measured by STAI. 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-The control group will be instructed to do their daily routine as it was before being part of the study. No intervention will be given to them.
2Intervention ArmLifestyle--Dinacarya: -, Ritucarya: -, Acara Rasayana:-, Other:Bhraamaree praanaayaama, Pathya/Apathya:no, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  20.00 Year(s)
Gender  Both 
Details  1. Students who are going to appear for upcoming NEET for the first time (fresher)
2. Participants who are component to give informed consent.
3. Students having mild to moderate stress trait anxiety as measured by STAI

 
 
ExclusionCriteria 
Details  1. Severe stress trait anxiety as measured by STAI
2. Past or present history of any psychiatric illness
3. Premenstrual syndrome
4. Over two weeks delay in the menstrual cycle
5. Subjects with ear, respiratory tract infections
6. Recent history of surgery of ear/ vocal apparatus
7. History of any other acute/chronic illness
8. Subjects on regular medication, especially on CNS drugs
9. Those practicing any form of Pranayama, Yoga, Meditation or other relaxation techniques for past one year
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare change in State Trait Anxiety Inventory (STAI) score, pulse rate (PR), blood pressure (BP), heart rate variability (HRV) & serum level of cortisol 4 months prior to exam & 3 months prior to exam in both trial & control groups


Secondary Outcomes

1.To record State Trait Anxiety Inventory (STAI) score, pulse rate (PR), blood pressure (BP), heart rate variability (HRV) & serum level of cortisol 4 months prior to exam & 3 months prior to exam in both groups

2.To calculate change in State Trait Anxiety Inventory (STAI) score, pulse rate, blood pressure (BP), heart rate variability (HRV) and serum level of cortisol after 1 month in both groups
 		 Before & after intervention which will be given for 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
1.To record State Trait Anxiety Inventory (STAI) score, pulse rate (PR), blood pressure (BP), heart rate variability (HRV) & serum level of cortisol 4 months prior to exam & 3 months prior to exam in both groups

2.To calculate change in State Trait Anxiety Inventory (STAI) score, pulse rate, blood pressure (BP), heart rate variability (HRV) & serum level of cortisol after 1 month in both groups 		 At day zero & After One month 
 
Target Sample Size   Total Sample Size="328"
Sample Size from India="328" 
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   N/A 
Date of First Enrollment (India)   04/01/2025 
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="6"
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  

The study titled “An open labelled two-armed randomised controlled trial to evaluate effect of Bhraamaree praanaayaama on pre-exam stress in students preparing for National Eligibility-cum-Entrance Test (NEET)” is an open labelled two-armed RCT.

It is designed to find that is braamaree praanaayaama done daily, 3 times a day, for 7 minutes each time, for a month, 4 months prior to NEET by students appearing for NEET, significantly reduces the pre-exam stress level in students, measured in terms of STAI score, pulse rate (PR), blood pressure (BP), heart rate variability (HRV), serum level of cortisol as compared to those who do not practice?

The study population will be all students in an urban area (Nashik City or Nagpur City) who are going to appear for NEET for the first time.

Sampling Technique: Simple Random Sampling and random allocation in two groups.

Effective sample size: Total 328 subjects assuming 10% non-response or loss of follow-up or dropout among the study subjects.

 

Inclusion Criteria:

Healthy students of age between 17-20 years and having mild to moderate stress trait anxiety as measured by STAI will be selected irrespective of gender.

Exclusion Criteria:

Students having severe stress trait anxiety as measured by STAI, past or present history of any psychiatric illness, premenstrual syndrome, over two weeks delay in the menstrual cycle, subjects with ear or respiratory tract infections, subjects having recent history of surgery of ear/ vocal apparatus or any other acute/chronic illness will be excluded.

Also, subjects on regular medication, especially on CNS drugs, and those practicing any form of Pranayama, Yoga, Meditation, or other relaxation techniques for the past year will be excluded.

Withdrawal Criteria:

If participants develop or get diagnosed with any psychological illness during the study, if they develop or get diagnosed with any disease which may worsen by intervention given during the study, if they show unwillingness for further participation or are unable to comply with study instructions or if they fail to attend an appointment after 30 days of intervention they will be withdrawn from the trial.

 
Close