| CTRI Number |
CTRI/2024/10/075951 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
21/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to test how well the tablet ANXO-125 works in treating people with Generalized Anxiety Disorder (GAD). |
|
Scientific Title of Study
|
A pilot study to evaluate the efficacy of tablet ANXO-125 in the management of generalized anxiety disorder (GAD). |
| 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 Madhulika D Tiwari |
| Designation |
Associate Professor |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre |
| Address |
Dr D Y Patil College of Ayurved and Research Centre
Dr D Y Patil Vidyapeeth (Deemed to be university)
Pimpri Pune Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
9158350066 |
| Fax |
|
| Email |
madhulika.tiwari@dpu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwin Shete |
| Designation |
Assistant Professor |
| Affiliation |
Dr D Y Patil College of Ayurveda and Research Centre |
| Address |
Dr D Y Patil College of Ayurved and Research Centre
Dr D Y Patil Vidyapeeth (Deemed to be university)
Pimpri Pune Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
9405716548 |
| Fax |
|
| Email |
ashwin3485@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogini M Bhoyar |
| Designation |
PG Scholar |
| Affiliation |
Dr D Y Patil College of Ayurved and Research Centre |
| Address |
Dr D Y Patil College of Ayurved and Research Centre
Dr D Y Patil Vidyapeeth (Deemed to be university)
Pimpri Pune Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
7350267705 |
| Fax |
|
| Email |
yogini17bhoyay@mail.com |
|
|
Source of Monetary or Material Support
|
| Sudhatatva pharmacy, Dr D Y Patil College of Ayurved and Research centre Pimpri Pune Maharshtra 411018 |
|
|
Primary Sponsor
|
| Name |
EVIMED SOLUTION |
| Address |
Plot No 17 Suuyojana Housing Society Lane No 4 Koregaon Park Pune 411001 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Madhulika D Tiwari |
Dr D Y Patil Ayurved Hospital |
Dr D Y Patil College of Ayurved and Research Centre
Dr D Y Patil Vidyapeeth
Pimpri Pune Maharashtra 411018
Pune
MAHARASHTRA |
9158350066
madhulika.tiwari@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr DYPCA and RC 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 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: ANXO 125, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 800(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed anxiety disorder.
Willingness to comply with study requirements and follow instructions.
Absence of significant cognitive impairment or comorbid psychiatric disorders.
Ability to provide informed consent.
Stable medication regimen for other medical conditions for at least 4 weeks prior to the |
|
| ExclusionCriteria |
| Details |
Individuals with known allergies to the contents of Drug.
Pregnant or breastfeeding women.
Individuals with associated comorbidities
Recent participation in another clinical trial. Presence of severe medical conditions or unstable psychiatric disorders.
Current substance abuse or dependence.
Use of medications known to interact with the study drug
Significant medical illness or unstable medical condition.
Use of other anxiolytic medications within the past 4 weeks.
Inability to comprehend or effectively communicate in the primary language of the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effectiveness of treatments in reducing symptoms mentioned in GAD scale. |
effectiveness of treatments in reducing symptoms mentioned in GAD scale in one month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Monitoring for adverse effects such as Exacerbation of anxiety symptoms |
Monitoring for adverse effects such as Exacerbation of anxiety symptoms done during follow up 10th, 20th and 30th day of treatment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
11/11/2024 |
| Date of Study Completion (India) |
29/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study aims to evaluate the efficacy of tablet Anxo 125 in Generalised Anxiety Disorder (GAD) . Anxo-125 tablet is a formulation designed to address the pervasive issue of anxiety disorders, offering an approach to symptom management. The extensive therapeutic effect of medicine is a cornerstone for the formulation of Anxo-125 tablet, a medication that includes Trilokya vijaya vati, Mandukparni, Jatamansi, Haritaki, and Guduchi for the management of anxiety disorders. Patients will be recruited after screening through Gad-7 scale and given with tablet Anxo 125 in 2 OD dosage at night after food. Then after treatment follow up will be done and conclusion will be drawn after statistical analysis. |