| CTRI Number |
CTRI/2023/09/058116 [Registered on: 29/09/2023] Trial Registered Prospectively |
| Last Modified On: |
26/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study and compare the effectiveness of Bhramari Pranayama and Music Therapy in Chittodvega (Test Anxiety) |
|
Scientific Title of Study
|
Randomized Comparative Study On The Effectiveness Of Bhramari Pranayama And Music Therapy In Chittodvega (Test Anxiety). |
| 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 Nikita Gopal Lande |
| Designation |
PG Scholar |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya,Amravati |
| Address |
OPD No. 18, Swasthvritta and Yoga Department,Vidarbha Ayurved Mahavidyalaya and Hospital,Dhanvantari Nagar,Amravati
Amravati
MAHARASHTRA
444605
India |
| Phone |
9423846095 |
| Fax |
|
| Email |
nikitalande75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay K Chopkar |
| Designation |
Guid and HOD Department of Swasthavritta and Yoga |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya,Amravati |
| Address |
Vidarbha Ayurved Mahavidyalaya,Dhanvantari Nagar,Amravati
Amravati
MAHARASHTRA
444605
India |
| Phone |
9423105104 |
| Fax |
|
| Email |
skchopkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikita Lande |
| Designation |
PG Scholar |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya,Amravati |
| Address |
Vidarbha Ayurved Mahavidyalaya,Dhanvantari Nagar,Amravati
Amravati
MAHARASHTRA
444605
India |
| Phone |
9423846095 |
| Fax |
|
| Email |
nikitalande75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vidarbha Ayurved Mahavidyalaya,Amravati |
|
|
Primary Sponsor
|
| Name |
Vidarbha Ayurved Mahavidyalaya,Amravati |
| Address |
Vidarbha Ayurved Mahavidyalaya,Dhanvantari Nagar,Amravati |
| 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 |
| Dr Nikita Lande |
Vidarbha Ayurved Mahavidyalaya, Amravati |
OPD No. 18 Swasthavritta and yoga department,
Vidarbha Ayurved Mahavidyalaya and Hospital,Dhanvantari Nagar, Amravati
Amravati
MAHARASHTRA |
9423846095
nikitalande75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S.H.V.P.M.Vidarbha Ayurved Mahavidyalaya,Amravati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F418||Other specified anxiety disorders. Ayurveda Condition: MANOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Procedure details: Music Therapy-Early morning listening of flute instrumental music(15 min) Raga desi todi of Pandit.Hariprasad Chaurassia.), Pathya/Apathya:, Pathya:, Apathya: | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Pranayama- Bhramari Pranayama- Early morning practice of Bhramari pranayama. Seat in comfortable meditation asana or in Siddhasana. Close the eyes and relax the whole body. The lips should remain gently closed with the teeth slightly separated and the jaws relaxed throughout the practice. This allows the sound vibrations to be heard and felt more distinctly. Plug the ears with thumbs, resting the other four fingers on the head and face (Shanmukhi mudra).
Take a deep breath (purak) and while exh, Pathya/Apathya:, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Those students who are diagnosed with test anxiety by the westside test anxiety scale.
Students who are physically and mentally healthy.
Those who are ready to sign informed consent form and be a part of study. |
|
| ExclusionCriteria |
| Details |
Subjects with known case of hearing disability and throat and nose problems.
Students having prior history of psychiatric illness.
Students with physical and mental disabilities.
Students with post traumatic stress.
Students with genetic and developmental disorders.
Students who are not willing to participate in study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Complete remission from chittodvega(Test anxiety).
Marked improvement in chittodvega(Test anxiety).
Mild improvement in chittodvega(Test anxiety). |
0th day
7th day
15th day
30th day
45th day
60th day
75th day
90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Remission from all kind of anxiety.
Mental peace establishment. |
30th day
50th day
70th day
90th day |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
04/10/2023 |
| 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="10"
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
|
A Randomised comparative clinical trial will be conducted to study the effectiveness of Bhramari pranayama and Music therapy in Chittodvega with special reference to Test anxiety. Trial will be conducted in our Institute and its periphery. Total 300 patients diagnosed with Test anxiety by Westside Test anxiety scale (given by Richard Driscoll and Westside psychology)will be selected and then will be divided in two groups. One group will be advised to do Bhramari Pranayama and other group will be advised for Music therapy(Raga Desi-Todi flute instrumental music of Pt.Hariprasad Chaurassia). The study will be done for 90 days. Results will be compared in two groups. Data analysis will be done by using appropriate statistical test. Primary outcomes will be to study the effectiveness of Bhramari pranayama and Music therapy in test anxiety and complete,moderate and mild remission of test anxiety in students.
|