| CTRI Number |
CTRI/2023/01/049160 [Registered on: 24/01/2023] Trial Registered Prospectively |
| Last Modified On: |
20/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Om Chanting and Bhramari pranayama] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of OM chanting and Bhramari pranayama along with Brahmi vati in improving reading and writing skill in children |
|
Scientific Title of Study
|
Study on effect of OM chanting and Bhramari pranayama along with Bramhi vati to improve concentration in children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anumit Kar |
| Designation |
student |
| Affiliation |
Shri Vijay Mahantesh Ayurvedic Medical college and Hospital |
| Address |
Department of Swasthavritta
Shri Vijay Mahantesh Ayurvedic Medical College and Hospital Ilkal
Bagalkot
KARNATAKA
587125
India |
| Phone |
8088179740 |
| Fax |
|
| Email |
karanumit98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M H Mali |
| Designation |
Professor |
| Affiliation |
Shri Vijay Mahantesh Ayurvedic Medical college and Hospital |
| Address |
Department of Swasthavritta
Shri Vijay Mahantesh Ayurvedic Medical College and Hospital Ilkal
Bagalkot
KARNATAKA
587125
India |
| Phone |
9880638260 |
| Fax |
|
| Email |
Dr.mahadevimali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M H Mali |
| Designation |
Professor |
| Affiliation |
Shri Vijay Mahantesh Ayurvedic Medical college and Hospital |
| Address |
Department of Swasthavritta
Shri Vijay Mahantesh Ayurvedic Medical College and Hospital Ilkal
Bagalkot
KARNATAKA
587125
India |
| Phone |
9880638260 |
| Fax |
|
| Email |
Dr.mahadevimali@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Vijay Mahantesh Ayurvedic medical college and hospital ilkal |
|
|
Primary Sponsor
|
| Name |
Principal |
| Address |
Shri Vijay Mahantesh Ayurvedic Medical college and Hospital ilkal |
| Type of Sponsor |
Private 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 |
| Anumit Kar |
Shri Vijay Mahantesh Ayurvedic Medical college and Hospital |
Department of Swasthavritta,
Shri Vijay Mahantesh Ayurvedic Medical college Ilkal
Bagalkot
KARNATAKA |
8088179740
karanumit98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy children |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:OM Chanting 10 times and Bhramari pranayama 10 times per day for 30 days, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Brahmi Vati, Reference: Ayurveda Sara Sangraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
School children well versed with english |
|
| ExclusionCriteria |
| Details |
School children those who were not willing to participate in the study.
School children those who were below 10 years and above 14 yrs of age.
School children those who were with sensory deficit.
School children with any other physical and mental illness
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the improvement in concentration with reference to writing and reading skill in children |
thirty days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the cause of lack of concentration with reference to the writing and reading skill in children |
before intervention at zero day |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/02/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
School children well versed with english irrespective of sex will be selected. A total of 70 children will be registered and divided into two groups. Group A will be prescribed OM chanting and Bhramari pranayama 10 times each for 30 days and group B will be prescribed Om chanting, Bhramari pranayama as before along with Brahmi vati 250 mg twice a day with water for 30 days. The subjects will be allotted to each group by randomization method. The assessment of concentration with reference to reading and writing skill will be assessed before and after intervention. The data analysis will be done by applying appropriate statistical tools.
|