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CTRI Number  CTRI/2025/02/081096 [Registered on: 21/02/2025] Trial Registered Prospectively
Last Modified On: 26/07/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [SHAVASANA]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Management of Chittodvega (Anxiety) Through Medhya Rasayana And Shavasana 
Scientific Title of Study   A Physiological Study To Evaluate The Effect Of Shavasana And Medhya Rasayana In Chittodvega With Reference To Anxiety  
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 Shivam Mahajan 
Designation  MD Scholar 
Affiliation  Madan Mohan Malviya Government Ayurved College 
Address  PG Department Of Kriya Sharir Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  7028197591  
Fax    
Email  shivmahajan78@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rekh Raj Meena 
Designation  Lecturer 
Affiliation  Madan Mohan Malviya Government Ayurved College 
Address  PG Department Of Kriya Sharir Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9414759170  
Fax    
Email  drrekhrajudr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rekh Raj Meena 
Designation  Lecturer 
Affiliation  Madan Mohan Malviya Government Ayurved College 
Address  PG Department Of Kriya Sharir Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9414759170  
Fax    
Email  drrekhrajudr@gmail.com  
 
Source of Monetary or Material Support  
Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur Rajasthan India 313001 
 
Primary Sponsor  
Name  Madan Mohan Malviya Government Ayurved College 
Address  Madan Mohan Malviya Government Ayurved College Radaji Choraha Udaipur Rajasthan India 313001 
Type of Sponsor  Government medical college 
 
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 Shivam Mahajan  Government Ayurved Hospital  OPD Room No 2 Motichohtta Udaipur Rajasthan India 313001
Udaipur
RAJASTHAN 
7028197591

shivmahajan78@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 
Patients  (1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: MANOVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: MEDHYA RASAYANA, Reference: ASHTANG HRIDAYAM, Route: Oral, Dosage Form: Khanda /Granules, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: GODUGDHA), Additional Information: -
2Comparator ArmLifestyle--Dinacarya: SHAVASANA, Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Individuals of either sex, between 18 to 40 years of age.

2. Individual who give consent for the study.

3. Diagnostic criteria of generalized anxiety disorder as per (DSM - V)

A) Excessive anxiety and worry (apprehensive expectation) occurring more days than not for at least 6 months, about a number of events of activities.
B) The person finds it difficult to control worry.

C) The anxiety and worry are associated with three (or more) of following six symptoms.

1. Restlessness or feeling keyed up or on edge.

2. Being easily fatigued.

3. Difficulty concentrating or mind going blank.

4. Irritability.

5. Muscle tension.

6. Sleep disturbance (difficulty in falling or staying asleep)

 
 
ExclusionCriteria 
Details  1. Individuals with age below 18 years and above 40 years.

2. Pregnant women and lactating mother.

3. Patients with diagnosed severe comorbid psychiatric illness and on medication for the same like bipolar disorder, schizophrenia, dementia, ADHD etc.
4. Patient with any severe/uncontrolled/chronic illness.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate the comparative effect of Medhya Rasayana and Medhya Rasayana along with
Shavasana in Chittodvega and anxiety.

 
60 DAYS

 
 
Secondary Outcome  
Outcome  TimePoints 
1. To interpret the conceptual and clinical correlation of Chittodvega and Anxiety.

2. To understand pathophysiology of Chittodvega and Anxiety.

3. To assess effect of Shavasana and Medhya Rasayana on Chittodvega (Anxiety) subjects.

4. To identify the mechanism of action of Shavasana and Medhya Rasayana drugs.
 
60 DAYS 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   21/07/2025 
Date of Study Completion (India) 27/02/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="7"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
10 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

The thesis explains that Chittodvega represents a minor psychic disorder with multiple somatic manifestations caused by an overactivation of Rajah and Tamas. This mental imbalance directly vitiates the Manovaha Srotas and disrupts physical Dosha, predominantly aggravating Prana, Udana, and Vyana Vayu, along with Sadhaka Pitta and Tarpaka KaphaThe statistical analysis derived from the clinical observations safely rejects the null hypothesis. The data confirms that the combined therapeutic regimen yields a statistically highly significant improvement (P < 0.001) in relieving both the psychic and somatic manifestations of anxiety.

The pharmacological action of Medhya Rasayana addresses this pathology directly: Mandukparni active saponins target the muscarinic acetylcholine receptor M1 to enhance memory; Shankhpushpi bio-chemicals interact with neuro-synapses to increase serotonin concentration; Ashwagandha steroidal lactones regulate the HPA axis to counter nervous exhaustion; Shatavari reduces brain MAO-A and MAO-B levels to exert antidepressant actions; and Yashtimadhu protects central neurons from oxidative stress.

The addition of Shavasana serves as a crucial somatic intervention. By inducing conscious stillness, it shifts autonomic tone from sympathetic dominance to parasympathetic compliance, relaxes overactive muscle contraction within the Mamsavaha Srotas, and clears background mental stress. This explains the marked superiority of Group B in eliminating chronic fatigue, reducing physical muscle rigidity, and restoring natural sleep architecture.

Based on the overall clinical, psychological, and statistical findings of the present study, it can be concluded that both Medhya Rasayana alone and Medhya Rasayana combined with Shavasana are safe and effective interventions for the management of anxiety disorder.

 

 
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