| CTRI Number |
CTRI/2024/04/065367 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
06/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Finding a relationship between the levels of a persons serum(blood component) uric acid and non alcoholic fatty liver disease. |
|
Scientific Title of Study
|
The Association of serum uric acid with non-alcoholic fatty liver disease – A case control study in a tertiary hospital in North Karnataka |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sohan Channeshappa Kotigera |
| Designation |
Post Graduate Student |
| Affiliation |
S. Nijalingappa Medical College, Bagalkot |
| Address |
Department of General Medicine, S. Nijalingappa Medical College, Navanagar, Bagalkot
Bagalkot
KARNATAKA
587102
India |
| Phone |
8277025456 |
| Fax |
|
| Email |
barbarickoti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramila Devi R |
| Designation |
Professor of Medicine |
| Affiliation |
S. Nijalingappa Medical College, Bagalkot |
| Address |
Department of General Medicine, S. Nijalingappa Medical College, Navanagar, Bagalkot
Bagalkot
KARNATAKA
587102
India |
| Phone |
|
| Fax |
|
| Email |
drprams06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sohan Channeshappa Kotigera |
| Designation |
Post Graduate Student |
| Affiliation |
S. Nijalingappa Medical College, Bagalkot |
| Address |
Department of General Medicine, S. Nijalingappa Medical College, Navanagar, Bagalkot
KARNATAKA
587102
India |
| Phone |
8277025456 |
| Fax |
|
| Email |
barbarickoti@gmail.com |
|
|
Source of Monetary or Material Support
|
| S. Nijalingappa Medical College, Navanagar, Bagalkot - 587102 |
|
|
Primary Sponsor
|
| Name |
Sohan Channeshappa Kotigera |
| Address |
Department of General Medicine, S. Nijalingappa Medical College, Bagalkot - 587102 |
| 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 Sohan Channeshappa Kotigera |
HSK Hospital, S.N.M.C Bagalkot |
Department of General Medicine, 2nd floor, S. Nijalingappa Medical College campus, Navanagar, Bagalkot
Bagalkot
KARNATAKA |
8277025456
barbarickoti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Institutional Ethics Committee, SNMC - Institutional ethics committee on human subjects research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy without the condition taken as controls |
| Patients |
(1) ICD-10 Condition: E888||Other specified metabolic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
Observational study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adults both the patients and the controls - healthy volunteers are observed and the parameters are noted. |
|
| ExclusionCriteria |
| Details |
Viral hepatitis
Alcohol consumption
Urico-suric drugs
carcinomas
drugs causing hyper-uricemia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Elevated or hyperuricemia in those who are currently with the condition of non alcoholic fatty liver |
baseline - at the time of observational analysis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Grade of the Hepatic Steatosis in correlation with the levels of Uric Acid |
Baseline at the time of observation |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
17/04/2024 |
| 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
|
The study is to identify if there is an association between the levels of the serum uric acid – a chemical which is present in the blood produced by bodily functions and the presence of non – alcoholic fatty liver disease- a condition where fat gets accumulated in the liver even though the person does not consume alcohol. This study aims to find out if there is in fact a link between these 2 parameters, and that by estimating this simple chemical by taking a blood sample we will be able to identify the likelihood and other related factors of the disease. All that would be required for the same is a scan of the stomach and a blood sample from the patient, and with that the analysis can be done for the study. Based on statistical tools a number of 30 has been derived wherein 30 participants who don’t have the disease will be tested for the chemical’s levels in the blood and 30 participants who do have the disease will undergo testing for its blood levels. A comparison will then be derived based on the findings. Hopefully a link will be established and this will save a lot of time and money in the future for the patients who are suffering or are on the verge of suffering from the disease, and will aid in the early recognition of the disease and its various manifestations allowing for a better method to identify and treat the disease. The study hypothesis is that those who are having non alcoholic fatty liver disease have elevated levels of uric acid in their blood. If this is the case - which the study aims to prove then further understanding of the condition both from a causative and a curative approach can be done, being of great benefit to patients. |