| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: MANOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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: - | | 2 | Comparator Arm | Lifestyle | - | - | 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 Kapha. The 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. |