| CTRI Number |
CTRI/2024/06/068714 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Samangadi Leha and Om-Chanting In management of Academic Stress In School-going Children |
|
Scientific Title of Study
|
Clinical study to evaluate the efficacy of samangadi leha and om chanting in the management of acedemic stress in school going children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishna |
| Designation |
MD Scholar |
| Affiliation |
Post Graduate Institute of Ayurveda, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University |
| Address |
PG Department of Kaumarbhritya Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadvad Jodhpur Rajasthan India
Jodhpur
RAJASTHAN
342037
INDIA
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9983420227 |
| Fax |
|
| Email |
Krishnagodara60@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish Kumar Singhal |
| Designation |
Associate Professor Head of Kaumarbhritya Department |
| Affiliation |
Post Graduate Institute of Ayurveda, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University |
| Address |
Room no 155 PG Department of Kaumarbhritya Post Graduate
Institute of Ayurveda, Dr Sarvepalli Radhakrishnan Rajasthan
Ayurved University Campus Kadvad Jodhpur Rajasthan 342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8619892143 |
| Fax |
|
| Email |
ayurharish14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish Kumar Singhal |
| Designation |
Associate Professor Head of Kaumarbhritya Department |
| Affiliation |
Post Graduate Institute of Ayurveda, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University |
| Address |
PG Department of Kaumarbhritya Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadvad Jodhpur Rajasthan India
Jodhpur
RAJASTHAN
342037
INDIA
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8619892143 |
| Fax |
|
| Email |
ayurharish14@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG Department of Kaumarbhritya, Post Graduate Institute of
Ayurveda, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved
University campus, Kadwad, Jodhpur, Rajasthan 342037 INDIA |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurveda JodhpurRajasthan |
| Address |
PG Department of Kaumarbhritya Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadwad Jodhpur Rajasthan 342037 INDIA |
| 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 |
| Dr Krishna |
Post Graduate Institute of Ayurveda |
OPD no 4 Department of Kaumarbhritya Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadawad Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN |
9983420227
Krishnagodara60@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Post Graduate Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F430||Acute stress reaction. Ayurveda Condition: MANOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Om Chanting duration of 5 minute three times a day, Pathya/Apathya:, Pathya:, Apathya: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Samangadi Leha, Reference: Kashyap Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Ghrita and Madhu), Additional Information: --Dose will be calculated according to Youngs Formula |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1.Individual between age group of 10-18 years of both sexes.
2.School going students of both gender those who are fulfilling the criteria of stress will be selected and screening will be done with Modified Perceived Stress Scale (PSS). |
|
| ExclusionCriteria |
| Details |
1.Children with known psychiatric disorders.
2.Children with gross damage causing mental retardation.
3.Children with known intellectual disability. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Samangadi Leha and OM chanting will be effective in the treatment of academic stress 101 School going children. |
45 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Prevalence of academic stress among students of selected schools in Jodhpur city
Samangadi Leha & OM chanting will be found effective in decrease of Students Stress inventory scores
Samangadi Leha & OM chanting have been found to be useful in lowering student stress test results
|
45days |
|
|
Target Sample Size
|
Total Sample Size="101"
Sample Size from India="101"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="0"
Days="15" |
|
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
|
Number of patients-101 Study type - open Labelled Single Arm Prospective Study Study Design- School based Clinical Study Drug -Samangadi Leha Dose-Samangadi Leha will be in a dose in to two divided doses as per Young Formula. Anupan -Oral medicine will be given with Honey and Ghrita Route - Samangadi Leha -Oral Route Mediation -OM Chanting will be advised to all selected patients of Academic stress. OM Chanting will be advocated 03 times in a day.Total three sittings will be advocated to all selected patients of Academic stress with duration of 5 minutes in one sitting. Randomization - Simple Duration Of Study- 45days Follow up- 15th day during trial period and 45 days & 90 after completion of the study |