| CTRI Number |
CTRI/2024/06/068882 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Validation and Standardization of Prameha diagnostic criteria and assessment of mental strength ,digestive power, and complications |
|
Scientific Title of Study
|
Standradization and validation of Prameha diagnostic criteria along with clinical assessment of Sattva,Agni, Kostha and Upadrava . |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrNeha kumari |
| Designation |
PG Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Vikriti Vigyan Faculty of Ayurveda Institute of Medical Science Banaras Hindu University Varanasi Uttar Pradesh India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8382889433 |
| Fax |
|
| Email |
neha20.kumari0697@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Parameswarappa S. Byadgi |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Vikriti Vigyan Faculty of Ayurveda Institute of Medical Science Banaras Hindu University Varanasi Uttar Pradesh India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9450711759 |
| Fax |
|
| Email |
psbyadgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrNeha kumari |
| Designation |
PG Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Vikriti Vigyan Faculty of Ayurveda Institute of Medical Science Banaras Hindu University Varanasi Uttar Pradesh India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8382889433 |
| Fax |
|
| Email |
neha20.kumari0697@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Vikriti Vigyan Faculty of Ayurveda Institute of Medical Science Banaras Hindu University Varanasi Uttar Pradesh India |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Science Banaras Hindu University Varanasi Uttar Pradesh India |
| Address |
Department of Vikriti Vigyan Faculty of Ayurveda Institute of Medical Science Banaras Hindu University Varanasi Uttar Pradesh India |
| 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 Neha Kumari |
Institute of Medical Sciences/ Sir Sundarlal Hospital |
Room no 23 ( S.S H. Indian medicine wing ,Room no 216 ( S.S.H. General medicine opd),Room no 218 ( S.S.H Super speciality building)
Varanasi
UTTAR PRADESH |
8382889433
neha20.kumari0697@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:E889||Metabolic disorder, unspecified. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: Nil, Ritucarya: Nil, Acara Rasayana:Nil, Other:Nil, Pathya/Apathya:, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who full filled the diagnostic criteria of Prameha |
|
| ExclusionCriteria |
| Details |
1. Semiconscious or unconscious patients
2. not willing to give consent for the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Standardization and Validation of the Prameha diagnostic criteria according to Sushruta |
1.5 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assessment of Satva,Agni,Kostha in Prameha patient.
2. Clinical assessment of Upadrava in Prameha patient. |
1.5 year |
|
|
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)
|
18/06/2024 |
| 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="6"
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
|
This study is a single group cross sectional study of prameha patients to - 1.Standardization and validation of Prameha diagnostic criteria according to Sushruta 2.Assessment of Satva, Agni Kostha in Prameha patients 3. Clinical assessment of Upadrava in Prameha patients |