| CTRI Number |
CTRI/2024/10/076069 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
AN OBSERVATIONAL STUDY OF MEDOVAHA SROTO DUSHTI IN NON- ALCOHOLIC FATTY LIVER DISEASE (NAFLD) |
|
Scientific Title of Study
|
TO STUDY ASSOCIATION OF NON-ALCOHOLIC FATTY LIVER DISEASE AND MEDOVAHA SROTO DUSHTI |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akash Dubey |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya Pune |
| Address |
Rognidan Department, Tilak Ayurveda Mahavidyalaya rasta peth Pune Tarachand hospital rasta peth Pune Maharashtra
Tilak Ayurved Mahavidyalaya rasta peth Pune Maharashtra 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
7000803056 |
| Fax |
|
| Email |
Akashdubey2105@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjiri Deshpande |
| Designation |
MD PhD Rognidan HOD Rognidan Department |
| Affiliation |
|
| Address |
Rog nidan department 1st floor Tilak Ayurveda Mahavidyalaya rasta peth Pune Maharashtra 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9960081113 |
| Fax |
|
| Email |
drmanjirideshpande24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjiri Deshpande |
| Designation |
MD PhD Rognidan HOD Rognidan Department |
| Affiliation |
|
| Address |
Rognidan Department 1st floor Tilak Ayurveda Mahavidyalaya rasta peth Pune Maharashtra 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9960081113 |
| Fax |
|
| Email |
drmanjirideshpande24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurveda Mahavidyalaya rasta peth Pune Maharashtra 411011 |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurveda Mahavidyalaya |
| Address |
Tilak Ayurveda Mahavidyalaya 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 Akash Dubey |
Tilak Ayurveda Mahavidyalaya, Akshay Hospital |
Rognidan department,Tilak Ayurved Mahavidyala Rasta Peth Pune,
Akshay Hospital opposite SNDT College Karve road near SBI Bank Pune
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
7000803056
Akashdubey2105@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TILAK AYURVED MAHAVIDYALAYA AND SETH TARACHAND RAMNATH CHARITABLE AYURVEDA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
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, (2) ICD-10 Condition:K760||Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: MEDOVAHASROTODUSHTIH, |
|
|
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, socio-economic status, race, religion.
2.Patients diagnosed as alcoholic fatty liver disease.
3.Patients those are willing for fibroscan. |
|
| ExclusionCriteria |
| Details |
1.Patients suffering from major illness who needs intensive care.
2.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 Non-alcoholic fatty liver disease and medovaha sroto dushti |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the pathophysiology of Non-alcoholic fatty liver disease in association to medovaha srotas
2. To study association of obesity & non-alcoholic fatty liver disease
3. To interpret reports of fibroscan, liver function test(LFT), lipid profile, HbA1C in patients of non
alcoholic fatty liver disease patients from ayurvedic perspective |
18 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/12/2024 |
| 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 medovaha srotas dushti To study the pathophysiology of Nonalcoholic fatty liver disease in association to medovaha srotas. To study association of obesity (sthaulya) and non alcoholic fatty liver disease. To interpret reports of fibroscan, liver function test(LFT), lipid profile, HbA1C in patients of non alcoholic fatty liver disease patients from ayurvedic perspective |