CTRI

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CTRI Number

CTRI/2025/12/099749 [Registered on: 23/12/2025] Trial Registered Prospectively

Last Modified On:

23/12/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A Clinical Study to Evaluate the Effect of Vruddhadaru Ghanavati in the Management of Chittodvega. (Generalized Anxiety Disorder)

Scientific Title of Study

A RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF VRUDDHADARU GHANAVATI IN THE MANAGEMENT OF CHITTODVEGA (GENERALIZED ANXIETY DISORDER).

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Abhijit Baburao Shinde
Designation	PhD Scholar
Affiliation	Bharati Vidyapeeth (Deemed To Be University)College of Ayurved And Hospital Pune
Address	Kayachikitsa Department Bharati Vidyapeeth College of Ayurved Pune Bharati Vidyapeeth Educational Campus Pune Satara Road Pune MAHARASHTRA 411043 India
Phone	8095311801
Fax	02024373954
Email	abhijit.shinde@bharatividyapeeth.edu

Details of Contact Person
Scientific Query

Name	Dr Virendra Baburao Pawar
Designation	Associate Professor
Affiliation	Bharati Vidyapeeth (Deemed To Be University)College of Ayurved And Hospital Pune
Address	Associate Professor Kayachikitsa Department Bharati Vidyapeeth College Of Ayurved And Hospital Pune Bharati Vidyapeeth College Of Ayurved and Hospital,Bharati Vidyapeeth Educational Campus Pune Pune MAHARASHTRA 411043 India
Phone	9096743333
Fax	02024373954
Email	virendra.pawar@bharatividyapeeth.edu

Details of Contact Person
Public Query

Name	Dr Abhijit Baburao Shinde
Designation	PhD Scholar
Affiliation	Bharati Vidyapeeth (Deemed To Be University)College of Ayurved And Hospital Pune
Address	Kayachikitsa Department Bharati Vidyapeeth College of Ayurved And Hospital Pune Bharati Vidyapeeth Educational Campus Pune Satara Road, Pune 411 043 Maharashtra INDIA Pune MAHARASHTRA 411043 India
Phone	8095311801
Fax	02024373954
Email	abhijit.shinde@bharatividyapeeth.edu

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Dr Abhijit Baburao Shinde
Address	Bharati Vidyapeeth College Of Ayurved And Hospital Bharati Vidyapeeth Educational Campus, Pune
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	Bharati Vidyapeeth Educational Campus, Pune – Satara Road, Pune –411 043 Maharashtra, INDIA

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Abhijit Shinde	Bharati Ayurved Hospital Pune	Kayachikitsa OPD Ground Floor Bharati Vidyapeeth College of Ayurved And Hospital Bharati Vidyapeeth Educational Campus Katraj Dhankawadi Pune Pune MAHARASHTRA	8095311801 02024373954 abhijit.shinde@bharatividyapeeth.edu

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICS COMMITTEE BVDUCOA-IEC	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:F40-F48\|\|Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders. Ayurveda Condition: CITTAVIPARYAYAJA-AROCAKAH/MANASSANTAPAJA-AROCAKAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Drug	Classical		(1) Medicine Name: Ashwagandha Ghanavati, Reference: Bhavaprakash Nighantu Guduchyadi Varga, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Go Ghrita), Additional Information: Patient can take Go Ghrita as anupana
2	Intervention Arm	Drug	Classical		(1) Medicine Name: Vruddhadaru Ghanavati , Reference: Kaiyadeva Nighantu Aushadhi Varga, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Go Ghrita), Additional Information: Patient can take Go Ghrita as Anupana.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	Excessive anxiety and worry occurring more days than not for at least 6 months, about a no. of events or activities The individual finds it difficult to control the worry. The anxiety and worry are associated with three (or more) of the following six symptoms (with at least some symptoms having been present for more days than not for the past 6 months): Restlessness or feeling keyed up or on edge. Being easily Fatigued Difficulty concentrating or mind going blank. Irritability Muscle tension Sleep disturbance (difficulty in falling or staying sleep or restless, unsatisfying) The anxiety worry or physical symptoms cause clinically significant distress or impairment in social, occupational or other important areas of functioning. The disturbance is not attributable to the physiological effects of a substance (e.g., a drug of abuse, a medication) or another medical condition (e.g., hyperthyroidism). Patients who are willing to participate and provide informed consen

ExclusionCriteria

Details

1. Pregnant or lactating women.
2. Patients with major psychiatric disorders other than GAD like schizophrenia,
bipolar disorder etc.
3. History of allergic reactions to herbal products.
4. Patients having any major systemic disorders such as cardiac, renal, hepatic, or
neurological diseases excluded.
5. Patients currently taking other anti-anxiety medications or undergoing
psychotherapy.

Method of Generating Random Sequence

Method of Concealment

Blinding/Masking

Primary Outcome

Outcome	TimePoints
1. Reduction in classical symptoms of Chittodvega. 2. Mean reduction in anxiety levels.	1st day of intervention 4th week 8th week

Secondary Outcome

Outcome	TimePoints
Improvement in sleep quality & overall quality of life	1st day of intervention 4th week 8th week

Target Sample Size

Total Sample Size="120"
Sample Size from India="120"
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

N/A

Date of First Enrollment (India)

14/01/2026

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="2"
Months="5"
Days="10"

Recruitment Status of Trial (Global)

Not Yet Recruiting

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 research is a randomized comparative clinical trial aimed at evaluating the effectiveness of Ayurvedic interventions in the management of Chittodvega (Generalized Anxiety Disorder). The study focuses on restoring mental balance by pacifying aggravated Vata Dosha, enhancing Satva Guna, and strengthening mental faculties such as Dhi (intellect), Dhriti (willpower), and Smriti (memory).

Participants will be randomly allocated into two groups and administered either Vruddhadaru Ghanavati or Ashwagandha Ghanavati. The therapeutic outcomes will be assessed based on improvement in anxiety symptoms, emotional stability, and overall mental well-being. This trial also aims to contribute to future research by exploring the role of Ayurveda as a safe and effective approach in managing anxiety-related psychiatric disorders. We will make sure it could be helpful to society.Thank You.