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CTRI Number  CTRI/2024/01/060996 [Registered on: 01/01/2024] Trial Registered Prospectively
Last Modified On: 03/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   An Ayurvedic intervention (AYUSH SR Tablet) for the management of stress among university students 
Scientific Title of Study   Efficacy and Safety of AYUSH SR tablet in the management of stress among University students – A double-blind randomized placebo-controlled study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kuldeep Singh 
Designation  Research Officer Ayurveda 
Affiliation  Central Ayurveda Research Institute (CARI) under CCRAS New Delhi 
Address  Central Ayurveda Research Institute (CARI), Road No.66, West Punjabi Bagh, New Delhi-110026
Road No.66, West Punjabi Bagh, New Delhi-110026
West
DELHI
110026
India 
Phone  8954354560  
Fax    
Email  kuldeepccras@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kuldeep Singh 
Designation  Research Officer Ayurveda 
Affiliation  Central Ayurveda Research Institute (CARI) under CCRAS New Delhi 
Address  Central Ayurveda Research Institute (CARI), Road No.66, West Punjabi Bagh, New Delhi-110026
Road No.66, West Punjabi Bagh, New Delhi-110026
West
DELHI
110026
India 
Phone  8954354560  
Fax    
Email  kuldeepccras@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kuldeep Singh 
Designation  Research Officer Ayurveda 
Affiliation  Central Ayurveda Research Institute (CARI) under CCRAS New Delhi 
Address  Central Ayurveda Research Institute (CARI), Road No.66, West Punjabi Bagh, New Delhi-110026
Road No.66, West Punjabi Bagh, New Delhi-110026
West
DELHI
110026
India 
Phone  8954354560  
Fax    
Email  kuldeepccras@gmail.com  
 
Source of Monetary or Material Support  
CCRAS, Ministry of AYUSH, Government of India  
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  61-65, Institutional Area, Opposite “D” Block, Janakpuri, New Delhi – 110058  
Type of Sponsor  Research institution 
 
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 
Kuldeep Singh  CCRAS-JNU Ayurveda Treatment & Research Facility  CCRAS-JNU Ayurveda Treatment & Research Facility, room 1 JNU Health Center ,Jawaharlal Nehru University Campus ,New Delhi, 110067
South West
DELHI 		 8954354560

kuldeepccras@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSITUTIONAL ETHICAL COMMITTEE CENTRAL AYURVEDA RESEARCH INSTITUTE NEW DELHI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F439||Reaction to severe stress, unspecified. Ayurveda Condition: MANOVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: AYUSH SR, Reference: Coded, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: water), Additional Information: -
2Comparator ArmDrugOther than Classical(1) Medicine Name: PLACEBO, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: WATER), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1.Students of any gender aged 18 – 30years.
2.Students with mild to moderate stress (score 20 to 29) based on Kessler Psychological Distress Scale (K10).
3.Students willing to participate in the clinical study and provide the signed informed consent.
 
 
ExclusionCriteria 
Details  1.Students with age below 18 years and above 30 years
2.Students suffering from other Psychiatric disorders or under medication for any psychiatric conditions.
3.Students with history of known cases of any major systemic illness such as cardiovascular, cerebrovascular, neurological, musculoskeletal diseases, thyroid disorders, immunosuppressive or immunodeficiency disorders and active malignancy
4.Students with concurrent hepatic dysfunction (defined as AST and or ALT greater than 2 times of the upper normal limit), or renal dysfunction (defined as serum creatinine greater than 1.2mg per lt), UNCONTROLLED PULMONARY DYSFUNCTION (ASTHMATIC AND COPD),uncontrolled diabetes mellitus with HbA1c above 8, uncontrolled hypertension BP greater than Systolic 160 and diastolic 100 mm hg
5.women who are planning to conceive, pregnant or lactatic women.
6.History of substance abuse, alcohol intake, chronic smoking or participants who are having any type of alcohol or smoking or substance or drugs etc.
7.History of any hypersensitivity to any of the trial drug or their ingredient.
8.Students who have completed participation in any other clinical trial during the past 3 months
9.Any other condition which the investigator think may jeopardize the subject and or study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in the Score (greater than 5) of Kessler Psychological Distress Scale (K 10)from baseline  After enrollment on day 1 and assessment will be done on 30th, 60th and 90th day. 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of adverse events during the study period  After enrollment assessment will be done on 30th, 60th and 90th day. 
Change in the laboratry safety parameters(CBC,LFT and LFT)  Assessment will be done before treatment on BASELINE and on 90th day. 
Change in the quality of life parameters (assessed through WHO-5 Well being Index)  After enrollment on day 1 and assessment will be done on 30th, 60th and 90th 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 3 
Date of First Enrollment (India)   08/01/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Stress remains highly prevalent among university students, making it imperative to explore therapeutic avenues for its prevention and reduction in this demographic. The relevance of Ayurvedic intervention becomes apparent, given its holistic approach, minimal adverse reactions, and significant potential in addressing lifestyle disorders. Valuable insights from clinical research in this area could play a pivotal role in effectively managing stress among university students.

Project Title: "Examining the Effectiveness and Safety of AYUSH SR Tablet in Alleviating Stress among University Students – A Double-Blind Randomized Placebo-Controlled Study"

Objectives: Primary Objectives:

  1. Evaluate the clinical efficacy of AYUSH-SR in managing stress among university students. Secondary Objective:
  2. Assess the clinical safety of AYUSH-SR in the management of stress among university students.

To achieve these objectives, students experiencing mild to moderate stress, as per the K10 scale, will be randomly assigned to two groups. Participants will receive either AYUSH SR tablets or AYUSH SR Placebo using a double-blind method. The study will meticulously evaluate the efficacy and safety of Ayush SR based on predefined criteria.

 
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