| CTRI Number |
CTRI/2025/09/094163 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Development of a standard tool to assess Meda Sara lakshana in healthy individual and to evaluate the such developed tool in healthy individuals for medosara purusha lakshana mentioned in classics |
|
Scientific Title of Study
|
Development of standardised tool for Meda Sara Pariksha |
| 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 Muktha p s |
| Designation |
BAMS Pg scholar |
| Affiliation |
SDM college of Ayurveda hospital and research centre |
| Address |
department of roganidana 2nd year pg scholar SDM college of Ayurveda hospital and research centre Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
7338088591 |
| Fax |
|
| Email |
mukthaps2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saritha t |
| Designation |
assistant professor |
| Affiliation |
SDM college of Ayurveda hospital and research centre |
| Address |
department of roganidana SDM college of Ayurveda hospital and research centre Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
7338088591 |
| Fax |
|
| Email |
mukthaps2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Muktha p s |
| Designation |
BAMS Pg scholar |
| Affiliation |
SDM college of Ayurveda hospital and research centre |
| Address |
department of roganidana 2nd year pg scholar SDM college of Ayurveda hospital and research centre Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
7338088591 |
| Fax |
|
| Email |
mukthaps2000@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Muktha PS |
| Address |
department of roganidana 2nd year pg scholar SDM college of Ayurveda hospital and research centre Udupi 574118 |
| Type of Sponsor |
Other [self] |
|
|
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 Muktha P S |
Sdm College of Ayurveda hospital research centre |
department of roganidana 2nd year pg scholar
Udupi
KARNATAKA |
7338088591
mukthaps2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM college of ayurveda udupi Institutional ethical clearance committee - human |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy volunteer |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Apparently Healthy individuals
2.Subjects of either gender of age 18-40 years.
3.Subjects having ability and willingness to sign the written informed consent
|
|
| ExclusionCriteria |
| Details |
1.Subjects suffering from acute or chronic illness and systemic illness.
2.Subjects with congenital deformities.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Develop and evaluate the parameters of meda sara in healthy individual |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/09/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is a cross sectional observational study to develop and evaluate parameters of meda sara purusha lakshana. here healthy individuals are selected in whom a developed tool will be studied for assessing and evaluating meda sara purusha lakshana as mentioned in the classics. |