| CTRI Number |
CTRI/2025/02/081096 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| 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)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
21/07/2025 |
| 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="0"
Months="7"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study the 60
clinically diagnosed patients of Chittodvega
/ Anxiety Subjects are divided into 2 groups
– 1) Medhya Rasayana 2) Medhya Rasayana along with Shavasana This study aims to evaluate
the comparative effect
of Medhya Rasayana and
Medhya Rasayana along with Shavasana in Chittodvega and
anxiety. |