An interventional study of Experimental and Experimental in Lipid Profile, Blood Glucose and Liver Enzymes, sponsored by University of Lahore. Not yet recruiting at 1 site in Pakistan. Open to participants aged 45 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by University of Lahore · Not applicable, Interventional, and Health services research
This RCT will evaluate the 12-week therapeutic effects of prickly pear pulp powder lozenges (0.5, 1.0, and 1.5 g/day) combined with an anti-inflammatory diet in adults with liver fibrosis (F1-F3).
Changes in ALT, AST, ALP, GGT, bilirubin, and clinical outcomes will be assessed to determine its potential as a safe, affordable, and hepatoprotective nutraceutical.
Liver fibrosis, a progressive outcome of chronic liver damage, represents a major and expanding issue affecting people's well-being, particularly in nations with limited resources like Pakistan. Although conventional treatments offer some benefits, they are often expensive, less accessible, and associated with adverse effects. This has led to rising interest in nutraceutical and plant-based therapies that provide safer, multifunctional alternatives. Opuntia ficus-indica (prickly pear cactus) is abundant in bioactive compounds such as betalains, flavonoids (quercetin, kaempferol, isorhamnetin), vitamin C, and polyphenols, which possess strong antioxidant, anti-inflammatory, hypoglycemic, and hepatoprotective activities. By regulating oxidative stress, redox balance, and lipid metabolism, Opuntia extracts may reduce hepatic steatosis and oxidative injury, highlighting its potential as a nutraceutical strategy for chronic liver disorders. This RCT is designed to investigate the therapeutic efficacy of prickly pear pulp powder in patients with liver fibrosis. The study will be conducted at the Food Science and Nutrition Laboratory, University of Lahore. Prickly pear pulp will be sourced from certified herbal suppliers will be dried, ground, and brewed to prepare the powder in the form of lozenges. Each lozenge produced will contain 0.5 g of prickly pear pulp powder. Treatment plan will be executed as follows: T1= 0.5g, T2=1g and T3=1.5g to patients along with anti-inflammatory dietary intervention. Patients (men and women aged 45-60) with clinically confirmed liver fibrosis (F1-F3, via transient elastography) will be enrolled and assigned into four intervention groups randomly. Participants will consume prickly pear pulp powder lozenges daily for 12 weeks. Biochemical and clinical assessments will be conducted pre- and post-intervention, including liver function tests (ALT, AST, ALP, GGT, bilirubin). Statistical analysis will be performed using SPSS, with a significance threshold of p \< 0.05. Preliminary evidence suggests that prickly pear pulp powder may serve as a safe, cost-effective hepatoprotective agent, potentially reducing fibrosis progression and enhancing liver function in affected individuals.
1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.
This study's planned enrollment of 120 is above the median of 78 across 739 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →University of Lahore is the lead sponsor of 232 studies on the registry; 41 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1 Lozenge (0.5 gm Prickly Pear Pulp Powder) \+ Anti Inflammatory Diet + Conventional Treatment
Dietary Supplement: Experimental
2 Lozenges (0.5 gm Prickly Pear Pulp Powder) 1+1 * Anti Inflammatory Diet * Conventional Treatment
Dietary Supplement: Experimental
3 Lozenges (0.5 gm Prickly Pear Pulp Powder) * Anti Inflammatory Diet * Conventional Treatment
Dietary Supplement: Experimental
simple lozenges
Other: Placebo
1 Lozenge (0.5 gm Prickly Pear Pulp Powder) \+ Anti Inflammatory Diet + Conventional Treatment once a day
2 Lozenges (0.5 gm Prickly Pear Pulp Powder) 1+1 * Anti Inflammatory Diet * Conventional Treatment
3 Lozenges (0.5 gm Prickly Pear Pulp Powder) * Anti Inflammatory Diet * Conventional Treatment
SIMPLE LOZENGESE
anthropometric measurement
weight (Kg)
Time frame: 12 weeks
Liver Enzymes
ALT, AST, ALP, and GGT are commonly reported in U/L
Time frame: 12 weeks
Glucose
Fasting glucose is reported in mg/dL, while HbA1c is reported as %.
Time frame: 12 weeks
BMI (kg/m^2)
Time frame: 12 WEEKS
lipid profile
Lipid profile parameters are generally reported as TC, TG, LDL-C, and HDL-C in mg/dL.
Time frame: 12 weeks
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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