- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07575789
Grape Seed Powder and Vitamin C Supplementation for Liver Disease (Acquired Hepatic Jaundice) (AHJ)
Impact of Grape (VITIS VINIFERA) Seed Powder Along With Vitamin C Supplementation on Serum Bilirubin Levels in Patients With Acquired Hepatic Jaundice
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
According to my study, the division of patients was done between two groups: one was named as Conventional group (CG) and other was named as Intervention group (IG). The conventional treatment group received only conventional medication and intervention group was given Grape-C capsule with dose of one tablet per day for 4 weeks after lunch along with conventional medication. Grape-C capsule continued for 4 weeks and the data was obtained at the initiation and at end of intervention (after 4th week).
According to my research study results the intervention group had a significant decrease in bilirubin levels, ALT, AST, ALP and increase the albumin and gamma glutamyl transferase (GGT) compared to the conventional group. The p-values for the comparison between pre and post intervention levels were highly significant rather than the conventional groups indicating a statistically significant difference.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan
- University of Lahore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both men and women
- Participants between the ages of 20-40 years will be included
- Patients having signs and symptoms of acquired hepatic jaundice
- Patients having high serum bilirubin, albumin, ALT, AST, ALP levels
- The patient having ALT level more than 10-50 U/L were included
- The participants having AST level above than 0-40 IU/L were included in this study
- Patients having ALP level more than 30 - 130 U/L were included in this research study
- Patients having level of bilirubin above than 0 - 21 μmol/L were included in this investigation
- Participants having the range of albumin more than 30-50 g/L were included in this research
- Participants those were underweighted were included
Exclusion Criteria:
- Patients who already taking any supplement or medication
- Participants taking any anti-inflammatory medications
- People who were suffering from any other disease
- Patients who have any known allergies
- Non willing patients
- Lactating women
- Pregnant women
- Smokers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Conventional group
Control group
|
|
|
Experimental: Intervention group
Targeted group with intervention
|
Grape-C supplement purchased from Nutrifactor brand.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bilirubin levels
Time Frame: 4 weeks
|
In this study results showed the significant decrease in bilirubin levels in interventional group as compared to the conventional group
|
4 weeks
|
Collaborators and Investigators
Investigators
- Study Chair: Dr Habib-ur-Rehman Rehman, PhD Food and Nutrition, University of Lahore
Publications and helpful links
General Publications
- DOI: 10.4103/1319-3767.65197
Helpful Links
- Ghaffar, S., Naqvi, M. A., Fayyaz, A., Abid, M. K., Khayitov, K. N., Jalil, A. T., Alsaikhan, F., Hammid, A. T., Al-Gazally, M. E., & Mohammadparast, V. (2022). What is the influence of grape products on liver enzymes? A systematic review and meta-ana
- Adikwu, E., & Deo, O. (2013). Hepatoprotective effect of vitamin C (ascorbic acid)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AZ786
- University of Lahore (Other Identifier: Self)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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