| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F489||Nonpsychotic mental disorder, unspecified. Ayurveda Condition: MANOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - | | 2 | Comparator Arm | Drug | Classical | | (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. |