| CTRI Number |
CTRI/2024/07/070161 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To Find out cause and Status of Pachan Shakti in Non Fatty Liver Patients
|
|
Scientific Title of Study
|
Analytical and Observational study to find out etiological factors and status of Agni in Patients of Yakritdalyudar specifically in Non alcoholic fatty liver disease.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Snehlata |
| Designation |
PG Scholar |
| Affiliation |
Institute for Ayurved Studies And Research |
| Address |
Department of Rog nidan evum vikriti vigyan Institute for Ayurved Stuidies and Research
Umri Road Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
9728265416 |
| Fax |
|
| Email |
snehapoonia06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepti Parashar |
| Designation |
Chairperson of Rog Nidan Evum Vikriti Vigyan Department |
| Affiliation |
Institute for Ayurved Stuidies and Research |
| Address |
Department of Rog Nidan Evum Vikriti Vigyan Institute for Ayurved Studies and Research
Umri Road Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
9468319931 |
| Fax |
|
| Email |
drdeeptiamehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Snehlata |
| Designation |
PG Scholar |
| Affiliation |
Institute for Ayurved Studies And Research |
| Address |
Department of Rog nidan evum vikriti vigyan Institute for Ayurved Stuidies and Research
Umri Road Sector 8 Kurukshetra 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
9728265416 |
| Fax |
|
| Email |
snehapoonia06@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved studies and Research Umri Road Sector 8 Kurukshetra 136118 Shri Krishna AYUSH University |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved studies and Research |
| Address |
Institute for Ayurved studies and Research Umri Road Sector 8 Kurukshetra 136118 |
| 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 Snehlata |
Institute for Ayurved studies and Research Hospital |
Room no 72d first floor Rog Nidan Evum Vikriti vigyan Department
Kurukshetra
HARYANA |
9728265416
snehapoonia06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Krishna Ayush University IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K760||Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patients of Yakritdalyudara (NAFLD)in age group of 25-50 years will be selected irrespective of sex,for the study.
Patients willing consent will be taken to proceed the study.
Patients of obesity DM, Dislipidemia will also be included in the study.
|
|
| ExclusionCriteria |
| Details |
Patients except age group of below 25 years and above 50 years will be excluded.
Patients not wiling for consent.
Patients with communicable disease.
Patients with disease i.e CA of liver, cirrhosis of liver, hepatic abscess, hepatitis, cholecystitis and other liver disease except non-alcoholic fatty liver disease.
Alcoholic patients.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study will help to determine specific factors and status of Agni in patients of Yakritdalyudara(NAFLD) in better way.
|
10 to 15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
This will also help to cure the patients and prevent progression of prevalence rate of disease and spread awareness.
|
10 to 15 minutes |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/07/2024 |
| 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
|
Analytical and Observational study has been designed to find out the etiological factors and status of Agni in Patients of Yakritdalyudara specifically in Non-alcoholic fatty liver disease, between the age group of 25 to 50 years irrespective of sex and already diagnosed cases of fatty liver are to be selected from OPD and IPD of IAS&R Hospital, Kurukshetra. |