| CTRI Number |
CTRI/2025/09/094448 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study of Dushivishari Agad to assess occupational stress among IT professionals. |
|
Scientific Title of Study
|
Clinical Evaluation Of Dushivishari Agad In Occupational Stress Among IT Professionals. |
| 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 Bhawana Mittal |
| Designation |
Assistant Professor |
| Affiliation |
Rishikul Campus Haridwar Uttarakhand Ayurved University |
| Address |
PG Department of Agadtantra and Vidhi Vaidyaka Rishikul Campus Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249401
India |
| Phone |
7891114932 |
| Fax |
|
| Email |
drbhawanamittal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhawana Mittal |
| Designation |
Assistant Professor |
| Affiliation |
Rishikul Campus Haridwar Uttarakhand Ayurved University |
| Address |
PG Department of Agadtantra and Vidhi Vaidyaka Rishikul Campus Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249401
India |
| Phone |
7891114932 |
| Fax |
|
| Email |
drbhawanamittal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rashi Negi |
| Designation |
MD Scholar |
| Affiliation |
Rishikul Campus Haridwar Uttarakhand Ayurved University |
| Address |
Department of Agadtantra and Vidhi Vaidyaka Rishikul Campus Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9860161120 |
| Fax |
|
| Email |
rashinegi12345@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus Haridwar Uttarakhand, India Pin code 249401 Uttarakhand Ayurved University |
|
|
Primary Sponsor
|
| Name |
Rishikul Campus Haridwar Uttarakhand Ayurved University |
| Address |
Rishikul Govt. PG college and hospital Haridwar Uttarakhand India Pin code 249401 |
| 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 Rashi Negi |
Rishikul Campus Ayurvedic Hospital Haridwar |
OPD No. 2 Department
of Agad tantra Rishikul Ayurvedic hospital Rishikul campus Haridwar 249401
Hardwar
UTTARANCHAL |
9860161120
rashinegi12345@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 |
| Patients |
(1) ICD-10 Condition:Z566||Other physical and mental strain related to work. Ayurveda Condition: UNMADA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dushivishari Agad, Reference: Ashtanga Hrudayam Uttarsthan 35th Chapter shlok no. 39, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: honey), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants having score between 21 and 40 based on The Workplace Stress Scale.
2. IT Professionals with a work experience of more than 1 year.
3. Having signs and symptoms of occupational stress.
4. Willing participants |
|
| ExclusionCriteria |
| Details |
1. Participants having score less than 21 based on The Workplace Stress Scale.
2. Suffering from any other psychological
disorder.
3. History of any substance abuse.
4. Suffering from any systemic
illness.(Diabetes, Hypertension, Thyroid
disorder)
5. Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
SUBJECTIVE PARAMETERS
1.Chinta (Worry)
2.Shoka (Grief)
3.Bhaya (Fear)
4.Krodha (Anger)
5.Bhrama (Dizziness)
6.Aswapna (Insomnia)
7.Alasya (Laziness)
8.Tandra (Lethargy)
9.Umatta Chittatvam (Mind instability)
10.Annanabhilasha (Loss of Appetite)
11.Ucchavas Adhyakam (Difficulty in breathing) |
Follow up at an interval of 15 days (15th day,30th and 45th day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
OBJECTIVE PARAMETERS
Perceived Stress Scale (Cohen S., & Williamson G. 1988) |
Score will be assessed at the baseline and on the 61st day (after 2 months) |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
19/09/2025 |
| 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="6"
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
|
Occupational stress in the IT sector is a multifaceted problem with maximum no. of professionals experience pressure from long working hours and demanding deadlines and poor work life balance. According to WHO approximately 1 in 5 workers quit their job due to stress. This study is a single arm open label clinical trial to evaluate the efficacy of Dushivishari Agad in occupational stress among IT professionals. The study will be conducted on total 40 patients which will be selected from OPD no.2 of Rishikul Campus Haridwar on the basis of inclusion and exclusion criteria. The duration of treatment is total 60 days. Screening of patient’s is done on the basis of THE WORKPLACE STRESS SCALE and assessment will be done on the basis of Subjective and Objective parameters. The selected drug will be a formulation of herbal drugs which is Dushivishari Agad in churna/powder form. This study is being conducted to provide safe and cost effective management for occupational stress in IT professionals. |