| CTRI Number |
CTRI/2024/05/066788 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
17/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A descriptive study of association of yakrutvikrti in patients of nonalcoholic fatty liver disease |
|
Scientific Title of Study
|
Association of nonalcoholic fatty liver disease and yakrutvikriti:A descriptive study |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prajakta Madhao Borkar |
| Designation |
PG scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Rognidan Department, Tilak Ayurved Mahavidyalaya Rasta Peth Pune Tarachand hospital Rasta Peth Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
8830440519 |
| Fax |
|
| Email |
bprajaktaborkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjiri Deshpande |
| Designation |
Professor MD Phd Rognidan |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya Rasta Peth Pune Tarachand hospital Rasta Peth Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9960081113 |
| Fax |
|
| Email |
drmanjirideshpande24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjiri Deshpande |
| Designation |
Professor MD Phd Rognidan |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya Rasta Peth Pune Tarachand hospital Rasta Peth Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9960081113 |
| Fax |
|
| Email |
drmanjirideshpande24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya Rasta Peth Pune Maharashtra |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyala Rasta Peth Pune Maharashtra 411011 |
| 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 Prajakta Madhao Borkar |
Tilak Ayurved Mahavidyala ,Akshay hospital |
Rognidan department,Tilak Ayurved Mahavidyala Rasta Peth Pune,
Akshay Hospital opposite SNDT College Karve road near SBI Bank Pune
Pune
MAHARASHTRA |
8830440519
bprajaktaborkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TILAK AYURVED MAHAVIDYALAYA AND SETH TARACHAND RAMNATH CHARITABLE HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K768||Other specified diseases of liver. Ayurveda Condition: YAKRUJJAVIDRADHIH, (2) ICD-10 Condition:K760||Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: YAKRUJJAVIDRADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Irrespective of age, sex, marital status, socieconomical status, race, religion.
2.Patients diagnosed as nonalcohic fatty liver disease.
3.Patients those are willing for fibroscan. |
|
| ExclusionCriteria |
| Details |
Patients suffering from major illness who needs intensive care.
patients who are alcoholic |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association of nonalcoholic fatty liver disease and yakrutvikriti. |
18 months, 0 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study etiopathogenesis of nonalcohlic fatty liver disease in terms of modern science & ayurveda
To study all strotas dushti lakshan in nonalcoholic fatty liver disease. |
18 months, 0 weeks |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
16/05/2024 |
| 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
|
To study association of nonalcoholic fatty liver disease and yakrutvikriti. To study the etiopathogenesis f nonalcoholic fatty liver disease in terms of modern science and ayurveda. To study all strotas dushti lakshan in nonalcoholic fatty liver disease To interpret reports of fibroscan in yakrutvikriti in the ayurved terms. |