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CTRI Number  CTRI/2025/02/080908 [Registered on: 19/02/2025] Trial Registered Prospectively
Last Modified On: 24/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Single Arm Study 
Public Title of Study   Preparation of Herbal Tea for stress  
Scientific Title of Study   A clinical study to evaluate the effect of Herbal infusion in Stress 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amulya Singh 
Designation  PG SCHOLAR 
Affiliation  D.Y. Patil School of Ayurveda, Nerul 
Address  D.Y. Patil School of Ayurveda deemed to be university, Nerul, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  7018929510  
Fax    
Email  singh.amulya22@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pratik M Patil 
Designation  Associate professor  
Affiliation  D.Y. Patil School of Ayurveda, Nerul 
Address  D.Y. Patil School of Ayurveda deemed to be university, Nerul, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9762224740  
Fax    
Email  pratik.patil@dypatil.edu  
 
Details of Contact Person
Public Query
 
Name  Amulya Singh 
Designation  PG SCHOLAR  
Affiliation  D.Y. Patil School of Ayurveda, Nerul 
Address  D.Y. Patil School of Ayurveda deemed to be university, Nerul, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  7018929510  
Fax    
Email  singh.amulya22@gmail.com  
 
Source of Monetary or Material Support  
D.Y. Patil school of ayurveda, Nerul, Navi Mumbai, Maharashtra, India, 400706 
 
Primary Sponsor  
Name  Amulya Singh 
Address  D.Y. Patil School of Ayurveda deemed to be university, Nerul, Navi Mumbai, Maharashtra 400706 
Type of Sponsor  Other [Self ] 
 
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 Amulya Singh  D.Y. Patil School of Ayurveda hospital  Swasthavritta O.P.D 6 D.Y. Patil School of Ayurveda deemed to be university Nerul Navi Mumbai 400706
Thane
MAHARASHTRA 
7018929519

singh.amulya22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Stressed anxious  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Herbal infusion , Reference: NA, Route: Oral, Dosage Form: Phanta, Dose: 100(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Subject with Percieved stress scale score ranging from 0-13 will be included
Subjects willing to give written informed consent
Subjects willing to follow up 
 
ExclusionCriteria 
Details  Subjects not willing to participate in study
Subjects with perceived stress score ranging from 14-40
Subjects suffering from chronic illness 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the effect of Herbal infusion in stress   30days 
 
Secondary Outcome  
Outcome  TimePoints 
To develop and standardize “Herbal infusion” from ayurvedic herbs.
• To observe the effectiveness of “herbal infusion” in stressed individuals
• To assess the quality of life. 
Duration 30 days 
 
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 
Date of First Enrollment (India)   03/03/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Background:Stress is a natural human response that prompts us to address challenges and threats in our lives. Everyone experiences stress to some degree. The way we respond to stress, however, makes a big difference to our overall well-being.Stress can lead to burnout—emotional exhaustion, depersonalization, and a sense of low personal accomplishment that leads to decreased effectiveness at work. About 500 million people worldwide are believed to be suffering from neurotic, stress related and psychological problems. The mention of Manovaha srotas appears in the description of psychological disorders. When the Manovaha srotases are occupied by morbid doshas, one could experience bad dreams.

When the manovaha srotases are afflicted by morbid doshas and get obstructed, mental diseases like unmaad are manifested. Factors vitiating manovaha srotas are the prime site of abnormalities of channels in all psychological disorders. [Cha. Ni. 7/4] So to overcome the stress a “herbal infusion” will be made. A “teabag” will be prepared which contains ayurvedic herbs which will help to reduce the stress. Material and methods: According to charaka chikitsa 9, the reference of Mahapaishachik ghrita is taken to make the formulation of “Herbal Infusion”. Here, Jatila(jatamansi),Mahapurushdanta(vishnukranta), Kayastha (sukshma ela) are taken to prepare the “herbal infusion”. These ingredients are chosen as these can be used as phanta. So, with the help of these three ingredients the effect on intellect and stress will be seen. Results: ‘Herbal infusion’ will show effective results in stress. Keywords: Stress, Ayurveda, Herbal infusion, etc. 

 
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