| CTRI Number |
CTRI/2025/09/094619 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Developing and testing a questionnaire to identify and monitor treatment improvement in patients with mental health problems |
|
Scientific Title of Study
|
Development and Validation of Ayurveda Dosha based Unmada Severity Scale” |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Umesh C |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Integrative Medicine, National Institute of Mental Health and Neurosciences, Bengaluru, Hosur main Road
KARNATAKA
560029
India |
| Phone |
9844145295 |
| Fax |
|
| Email |
drumeshayu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh C |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Integrative Medicine, National Institute of Mental Health and Neurosciences, Bengaluru.
KARNATAKA
560029
India |
| Phone |
9844145295 |
| Fax |
|
| Email |
drumeshayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Umesh C |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Integrative Medicine, National Institute of Mental Health and Neurosciences, Bengaluru.
KARNATAKA
560029
India |
| Phone |
9844145295 |
| Fax |
|
| Email |
drumeshayu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIMHANS |
| Address |
National Institute of Mental Health and Neurosciences, Hosur Road, Bengaluru - 560029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Umesh C |
National Institute of Mental Health and Neurosciences |
National Institute of Mental Health and Neurosciences, Hosur Road, Bengaluru - 560029
Bangalore
KARNATAKA |
07975856612
drumeshayu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS Ethics Committee (Behavioural Science Division) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F200||Paranoid schizophrenia. Ayurveda Condition: UNMAD, (2) ICD-10 Condition:F201||Disorganized schizophrenia. Ayurveda Condition: UNMAD, (3) ICD-10 Condition:F202||Catatonic schizophrenia. Ayurveda Condition: UNMAD, (4) ICD-10 Condition:F203||Undifferentiated schizophrenia. Ayurveda Condition: UNMAD, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects fulfilling the criteria for diagnosis of Psychosis [Schizophrenia spectrum disorder/ Mania with Psychotic symptoms/ Depression with Psychotic Symptoms] as per DSM-V.
2. Subjects aged between 18 to 50 years.
3. Both male and female subjects.
4. Subjects willing to provide consent.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with other psychiatric illnesses such as anxiety, OCD, phobia and panic disorders.
2. Subjects with alcohol dependence and substance abuse or dependence.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Develop and validate an Ayurveda dosha based Unmada severity Scale. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To establish concurrent validity of developed scale with Brief Psychiatry Rating Scale. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="320"
Sample Size from India="320"
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)
|
06/11/2025 |
| 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="1"
Months="0"
Days="0" |
|
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
|
The aim of the study is to develop; content validate an Ayurveda based scale that would help in diagnosis and measure the treatment outcomes of the disease Unmada (Psychosis). Further the developed and validated scale will be tested to establish its concurrent validity with Brief Psychiatry rating Scale. This would be the first scale in Ayurveda that would be developed and validated to diagnose and measure treatment outcomes of a Psychiatric disorder. |