| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stressed anxious |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other 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 Infusionâ€. Here, Jatila(jatamansi),Mahapurushdanta(vishnukranta), Kayastha (sukshma ela) are taken to prepare the “herbal infusionâ€. 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. |