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CTRI Number  CTRI/2025/02/080165 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 05/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical trial on Yashtimadhu Vs Ashwagandha in Stress. 
Scientific Title of Study   Efficacy of Yashtimadhu In Comparison With Ashwagandha In Stress With Special Reference To Depression Anxiety Stress Scale (DASS-21): A Randomized Control Trial  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Yogita Pole 
Designation  PG Scholar Department of Kaychikitsa 
Affiliation  Government Ayurvedic College and Hospital Nagpur Sakkardara 
Address  Department of Kaychikitsa OPD No.1 Government Ayurvedic Hospital Sakkardara Raje Raghuji Nagar Nagpur.

Nagpur
MAHARASHTRA
440024
India 
Phone  9075637847  
Fax    
Email  yogitapole1111@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrAmit Nakanekar 
Designation  Assistant Professor  
Affiliation  Government Ayurvedic College and Hospital Nagpur Sakkardara 
Address  Department of Kaychikitsa OPD No.5 Government Ayurvedic Hospital Sakkardara Raje Raghuji Nagar Nagpur.

Nagpur
MAHARASHTRA
440024
India 
Phone  9075637847  
Fax    
Email  amitnakanekar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  yogita Pole 
Designation  PG Scholar Department of Kaychikitsa 
Affiliation  Government Ayurvedic College and Hospital Nagpur Sakkardara 
Address  Department of Kaychikitsa OPD No.1 Government Ayurvedic Hospital Sakkardara Raje Raghuji Nagar Nagpur.

Nagpur
MAHARASHTRA
440024
India 
Phone  9075637847  
Fax    
Email  yogitapole1111@gmail.com  
 
Source of Monetary or Material Support  
Department of kaychikitsa opd no.1 Government Ayurveda college Nagpur India 440024 
 
Primary Sponsor  
Name  Yogita Pole 
Address  Department of Kaychikitsa OPD No. 1 Government Ayurvedic Hospital Sakkardara Raji Raghuji Nagar Nagpur India 440024 
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 Yogita Pole  Government Ayurved College Nagpur  Department of kaychikitsa opd no.1 Government Ayurved College Sakkardara Raje Raghuji NagarNagpur
Nagpur
MAHARASHTRA 
9075637847

yogitapole1111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Government Ayrved College Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F489||Nonpsychotic mental disorder, unspecified. Ayurveda Condition: MANOVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Yashtimadhu churna, Reference: CHARAKSAMHITA CHIKITSASTHANA CHAPTER NO.1.3 Verse No.30, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Ashwagandha churna, Reference: sodhalnighantu, Guduchyadivarga: Chapter 1, verse no 196-197, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.All the patients with symptoms of stress from at least 15 days to 1 year with a
score between 15-33 in the DASS-21 Scale.
2.Male and female adults aged between 18 and 65 years.
3.Participants are willing to participate in the study and comply with its
procedures by signing a written informed consent.
 
 
ExclusionCriteria 
Details  1. DASS -21 Score less than 15 and More than 33.
2. Pregnant women and lactating mothers.
3. People with a known hypersensitivity to study medications will be excluded.
4. Patients with serious life-threatening critical illnesses that may interfere with the current study.
5. People reported alcohol dependence and drug abuse.
6. People taking any other investigational drug for another clinical trial/research are also ineligible.
7. Patient with addiction to Narcotics.
8. Patients taking medicines that may interfere with the study outcome.
9. Patients are not willing to participate and are not ready to give written informed consent.
10. Patients having uncontrolled HTN BP > 150/90 mmHg, Known case of Uncontrolled DM with HbA1C >8.
11. The patient taking any other hormonal or psychiatric treatment since last 1 month.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in DASS-21 Scale  Day 0,Day 7, Day 14,Day 21 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in PSS Scale  Day 0,Day 7, Day 14,Day 21 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
Final Enrollment numbers achieved (Total)= "82"
Final Enrollment numbers achieved (India)="82" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   17/02/2025 
Date of Study Completion (India) 30/04/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/04/2026 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
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, anxiety, and depression are more common mental health issues that significantly affect individuals’ quality of life.  Although there are allopathic treatments for stress, they are often associated with adverse side effects and limited multi-targeted action. In contrast, Ayurvedic herbal remedies, known for their safety and holistic therapeutic effects, are gaining popularity Among them, Yashtimadhu, recognized for its multi-targeted action, particularly on the Manovaha Strotas, has demonstrated neuropharmacological properties, including nootropic, antidepressant, antistress, and anxiolytic effects. Ashwagandha is a well-researched adaptogen that is used extensively for its ability to improve mood and reduce stress. However, there is limited evidence comparing their effectiveness in stress management, particularly in the context of the Depression Anxiety Stress Scale (DASS-21).

Objective: This randomized controlled trial aimed to evaluate and compare the efficacy of Yashtimadhu and Ashwagandha in managing stress, using the

Depression Anxiety Stress Scale (DASS-21) as a primary assessment tool.

Methods: Total 82 participants experiencing stress will be randomly assigned to two groups: Yashtimadhu and Ashwagandha. The trial will have a duration of 3 weeks, with dose of 5gm Churna BD administered according to standard Ayurvedic recommendations. Pre- and post-treatment assessments using the DASS-21 scale will be conducted to measure the levels of depression, anxiety, and stress. The PSS Scale is also used to assess stress.

Results: The results of this study will potentially influence clinical practices and highlight the role of traditional herbal remedies in contemporary stress management strategies.

Conclusion: The final conclusion will be determined after the completion of the randomized controlled trial, which will assess the comparative efficacy of Yashtimadhu and Ashwagandha in the management of stress.

Keywords: Stress, Yashtimadhu, Ashwagandha,  DASS-21, mental health, Ayurveda.

 

 
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