| Trial ID: | L0802 |
| Source ID: | CTRI/2017/12/010997
|
| Associated Drug: |
VSL#3
|
| Title: |
The Effect of Probiotic VSL#3 and Lifestyle Intervention in Obese Children with Non Alcoholic Fatty Liver Disease(NAFLD):A Randomized Clinical Trial - NA
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
--
|
| Interventions: |
Intervention1: VSL#3 probiotic <br>live freeze dried lactic acid bacteria and bifidobacteria capsules: 4 capsules of VSL#3 probiotic less than 10yrs and 8 capsules above 10 yrs for 4 months<br>Control Intervention1: Placebo capsules containing corn starch
|
| Outcome Measures: |
The primary outcome is the evaluation of beneficial effect of probiotic VSl#3 for the treatment of fatty liver disease in obese childrenTimepoint: 4 months interventionAssessment of Probiotic VSL#3 for controlling the biochemical parameters LFT Lipid profile etc Hunger hormone leptin ghrelinTimepoint: 4 months intervention
|
| Sponsor/Collaborators: |
Babe Ke Ayurvedic Hospital VPO Daudhar
|
| Gender: |
--
|
| Age: |
nannan
|
| Phases: |
Phase 1
|
| Enrollment: |
100
|
| Study Type: |
Interventional
|
| Study Designs: |
Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Participant and Investigator Blinded
|
| Start Date: |
27/12/2017
|
| Completion Date: |
07/01/2019
|
| Results First Posted: |
--
|
| Last Update Posted: |
24 November 2021
|
| Locations: |
India
|
| URL: |
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19361
|
