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CTRI Number  CTRI/2024/11/076649 [Registered on: 11/11/2024] Trial Registered Prospectively
Last Modified On: 04/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Clinical trial to study the effect of Samangadi Churna in Academic stress in Adolescent age group 
Scientific Title of Study   A Single Arm Open Labelled Clinical Trial to Evaluate the Efficacy Of Samangadi Churna in the Management Of Academic Stress in Adolescent Age 
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 Abhishek Thakur 
Designation  PG SCHOLAR 
Affiliation  Institute For Ayurved Studies And Research 
Address  Department of Kaumarbhritya Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra 136118

Kurukshetra
HARYANA
136118
India 
Phone  7986466052  
Fax    
Email  abhishekthakur164158@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Vd S D Sharma 
Designation  Chairperson PG Dept. of Kaumarbhritya 
Affiliation  Institute For Ayurved Studies And Research 
Address  Department of Kaumarbhritya Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra 136118

Kurukshetra
HARYANA
136118
India 
Phone  7988688231  
Fax    
Email  sharmasddr@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhishek Thakur 
Designation  PG Scholar 
Affiliation  Institute For Ayurved Studies And Research  
Address  Department of Kaumarbhritya Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra 136118

Kurukshetra
HARYANA
136118
India 
Phone  7986466052  
Fax    
Email  abhishekthakur164158@gmail.com  
 
Source of Monetary or Material Support  
Institute For Ayurved Studies And Research Shri Krishna Ayush University Umri Road Sector 8 Kurukshetra 136118 India 
 
Primary Sponsor  
Name  Institute For Ayurved Studies And Research 
Address  Institute For Ayurved Studies And Research Shri Krishna Ayush University Umri Road Sector 8 Kurukshetra 136118 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhishek Thakur  Institute For Ayurved Studies and Research Hospital  Room No 53 PG Department of Kaumarbhritya Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA 		 7986466052

abhishekthakur164158@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shri Krishna Ayush University IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F430||Acute stress reaction. Ayurveda Condition: MANOVAHASROTODUSHTIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Samangadi churna, Reference: Kashyapa samhita lehana chapter, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -madhu and ghrita in unequal amount), Additional Information: -nil
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Parents of children willing to participate in the research trial
Individual between age group of 10 to 18 years of either sex having symptoms of stress.
School going students of any gender those who are fulfilling the criteria of stress will be
selected on the basis of Perceived Stress Scale (PSS SCALE) grading. 
 
ExclusionCriteria 
Details  Children below 10 year and above 18 years of age.
Children with any systemic disorder
Children having congenital anomalies.
Children with known intellectual disability
Parents of children not willing to participate in the research trial 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
It will be assessed on the basis of statistical analysis applied on subjective parameter and
objective parameter after completion of trial 		 21 days 
 
Secondary Outcome  
Outcome  TimePoints 
Literary data related to Academic Stress and Chittodvega will be compiled from different texts of Ayurveda and modern part.
To reduce drop out in school due to stress 		 7th 14th 28th day and 35th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   03/12/2024 
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="1"
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  
A single arm open labelled clinical trial to evaluate the efficacy of Samangadi churna in the management of Academic stress in  Adolescent Age .My research will adopt a holistic approach to treat academic stress in  adolescents. The study will involve the assessment of specific biomarkers, such as serum cortisol (S. cortisol), and the grading of stress levels using the Perceived Stress Scale (PSS).The prevalence of academic stress is steadily increasing among adolescents, and there is a  significant gap in effective management and counseling for affected students. Given that academic stress impacts the mind and cognitive functions, a holistic Ayurvedic approach is essential. MedhyaRasayana (nootropic herbs), as part of Yuktivyapashraya Chikitsa, can play a vital role in enhancing cognitive functions, improving memory, and reducing stress. These herbs not only strengthen mental faculties but also provide a natural, side-effect-free alternative to conventional treatments, promoting overall mental well-being in students.
 
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