| CTRI Number |
CTRI/2020/08/027091 [Registered on: 11/08/2020] Trial Registered Prospectively |
| Last Modified On: |
25/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A survey trial to evaluate the efficacy of brahmi and tulsi on academic stress |
|
Scientific Title of Study
|
A survey study on prevalence of academic stress in school children and a comparative clinical trial to evaluate the efficacy of brahmi and tulsi on academic stress. |
| Trial Acronym |
AS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Mausalpuri |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Department of Kaumarbhritya, NIA Jaipur
P.G. Department of Kaumarbhritya, NIA Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7568236809 |
| Fax |
|
| Email |
nmosalpuri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Kumar Nagar |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
P.G. Department of Kaumarbhritya, NIA Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414062099 |
| Fax |
|
| Email |
drrknagar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisha Kumari ojha |
| Designation |
Assistant professor & Head of Department |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
P.G. Department of Kaumarbhritya, NIA Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9468650449 |
| Fax |
|
| Email |
drnishaojha@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jaipur |
|
|
Primary Sponsor
|
| Name |
NIA Jaipur |
| Address |
National Institute of Ayurveda , Jorawar Singh Gate, Amer Road, Jaipur |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Neha Mausalpuri |
Patients attending the OPD and IPD of N.I.A. Balroga Department, Jaipur. |
Jaipur
Jaipur
RAJASTHAN |
7568236809
nmosalpuri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee NIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Academic Stress |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brahmi Extract |
Latin name-Bacopa monnieri
Family-Scrophulariacae
Useful Part-Whole plant
Dose-250 mg BD for 90 days |
| Comparator Agent |
Tulsi Extract |
Latin name-Ocimum sanctum Family-Labiatae
Useful Part-Leaf
Dose-250 mg BD for 90 days |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Students of class 10th of any gender those who are fulfilling the criteria of stress will be selected and screening will be done with modified perceived stress scale. |
|
| ExclusionCriteria |
| Details |
(1) Children with known psychiatric disorders.
(2) Children with gross damage causing mental retardation.
(3) Children with known intellectual disability.
(4) Those who don’t want to be a part of the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Prevalence of academic stress among students of 10th class of schools of Jaipur city.
2. Prevalence of academic stress in different population.
3. To compare the efficacy of Brahmi and Tulsi in academic stress. |
03 months in Clinical study October 2019 to January 2021 in Survey study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To helps the subjects to relieve in the symptoms of academic stress. |
03 months in Clinical study October 2019 to January 2021 in Survey study. |
|
|
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 2 |
|
Date of First Enrollment (India)
|
20/08/2020 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Academic stress is a mental distress with respect to some anticipated frustration associated with academic failure or even awareness of the possibility of such failure.Academic stress pervades the life of students and tends to impact adversely their mental and physical health, and their ability to perform academic/school work effectively. Stress brings many undesirable outcomes with it, majorly behavioral problems in a child. Sudden change in the psychological set up leads to his/her maladjustment with the family members, siblings, friends etc. which secludes him/her from the rest and develops many symptoms like phobia, manias, severe depression and can also result in suicidal attempts by the child. |