Assessment of safety and efficacy of a dietary supplement KaraLiv™ in supporting liver health: a double-blind, parallel, placebo-controlled randomized clinical trial

Background: The liver is responsible for many critical functions within the body. If the liver becomes diseased or injured, loss of those critical functions can cause significant damage to the body. KaraLivTM is a novel herbal formulation which contains a blend of different herbal extract ingredients. The current study tested the safety and efficacy of KaraLivTM versus a placebo control in supporting liver function.Methods: The study is a randomized, double-blind, parallel, and placebo-controlled study. A total of 60 patients were divided into 2 groups of 30 each. One group was given KaraLivTM and the other group was given a placebo for a period of 56 days. Treatment results were assessed by evaluating the levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, and alkaline phosphatase (ALP) in both groups.Results: The herbal supplement KaraLivTM significantly supported healthy liver function compared to the placebo following the 56 days of treatment. The treatment (KaraLivTM) group showed a statistically significant improvement in assessed liver enzyme levels compared to the placebo group.Conclusions: The all-natural herbal supplement KaraLivTM is a safe and effective product that can significantly help support healthy liver function.

Download Full-text

Faculty Opinions recommendation of Safety and efficacy of monoclonal antibody VIS410 in adults with uncomplicated influenza A infection: Results from a randomized, double-blind, phase-2, placebo-controlled study.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.734858436.793573735 ◽

2020 ◽

Author(s):

Graham Pawelec

Keyword(s):

Monoclonal Antibody ◽

Influenza A ◽

Controlled Study ◽

Phase 2 ◽

Double Blind ◽

Safety And Efficacy

Download Full-text

Safety and Efficacy of Monoclonal Antibody VIS410 in Adults with Uncomplicated Influenza A Infection: Results from a Randomised, Double-Blind, Placebo-Controlled Study

SSRN Electronic Journal ◽

10.2139/ssrn.3271424 ◽

2018 ◽

Author(s):

Ellie Hershberger ◽

Susan Sloan ◽

Kristin Narayan ◽

Catherine A. Hay ◽

Patrick Smith ◽

...

Keyword(s):

Monoclonal Antibody ◽

Influenza A ◽

Controlled Study ◽

Double Blind ◽

Safety And Efficacy ◽

Double Blind Placebo

Download Full-text

Randomised clinical trial: the safety and efficacy of AST-120 in non-constipating irritable bowel syndrome - a double-blind, placebo-controlled study

Alimentary Pharmacology & Therapeutics ◽

10.1111/j.1365-2036.2011.04818.x ◽

2011 ◽

Vol 34 (8) ◽

pp. 868-877 ◽

Cited By ~ 27

Author(s):

J. F. Tack ◽

P. B. Miner ◽

L. Fischer ◽

M. S. Harris

Keyword(s):

Clinical Trial ◽

Irritable Bowel Syndrome ◽

Randomised Clinical Trial ◽

Controlled Study ◽

Double Blind ◽

Safety And Efficacy ◽

Double Blind Placebo ◽

Irritable Bowel

Download Full-text

Safety and Efficacy of a New 3.3g b.i.d. Tablet Formulation in Patients With Mild-to-Moderately-Active Ulcerative Colitis: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

Yearbook of Gastroenterology ◽

10.1016/s0739-5930(09)79361-4 ◽

2009 ◽

Vol 2009 ◽

pp. 110-111

Author(s):

M.F. Picco

Keyword(s):

Ulcerative Colitis ◽

Tablet Formulation ◽

Controlled Study ◽

Active Ulcerative Colitis ◽

Double Blind ◽

Safety And Efficacy ◽

Double Blind Placebo

Download Full-text

Evaluation of the Safety and Efficacy of a Multienzyme Complex in Patients with Functional Dyspepsia: A Randomized, Double-Blind, Placebo-Controlled Study

Journal of Medicinal Food ◽

10.1089/jmf.2017.4172 ◽

2018 ◽

Vol 21 (11) ◽

pp. 1120-1128 ◽

Cited By ~ 2

Author(s):

Muhammed Majeed ◽

Shaheen Majeed ◽

Kalyanam Nagabhushanam ◽

Sivakumar Arumugam ◽

Anurag Pande ◽

...

Keyword(s):

Functional Dyspepsia ◽

Controlled Study ◽

Multienzyme Complex ◽

Double Blind ◽

Safety And Efficacy ◽

Double Blind Placebo

Download Full-text

Olfactory ensheathing cells in chronic ischemic stroke: A phase 2, double-blind, randomized, controlled trial

Journal of Neurorestoratology ◽

10.26599/jnr.2020.9040019 ◽

2020 ◽

Vol 8 (3) ◽

pp. 182-193

Author(s):

Yunliang Wang

Keyword(s):

Ischemic Stroke ◽

Olfactory Ensheathing Cells ◽

Controlled Study ◽

Cell Group ◽

Placebo Control ◽

Phase 2 ◽

Double Blind ◽

Assessment Scores ◽

Ensheathing Cells

Olfactory ensheathing cells (OECs) have shown promising results for patients with neurologic diseases in non-double-blind, placebo control studies. Thirty patients with a unilateral ischemic stroke of more than a year were enrolled in a phase 2, multicenter, randomized, double-blind, and placebo-controlled cell therapy trial with a subsequent 12-month follow-up. The primary therapeutic objective has shown that after 12 months, there were significant differences in National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS) and Barthel Index (BI) assessment scores among the OEC group, Schwann cell group and placebo medium group at one-year follow-up. The second therapeutic objective found that there were significant differences in NIHSS, mRS, and BI assessment scores when comparing the endpoint data with the baseline data in the OEC group. There was neither hypersensitivity reaction nor adverse event. The results of this multicenter, randomized, double-blind, and placebo-controlled study indicate that injecting OECs into the olfactory sub-mucosa have neurorestorative effects, which can improve the quality of life for patients with chronic ischemic strokes without serious side effects.

Download Full-text

Safety and Efficacy of a Topical Anesthetic for Neonatal Circumcision

PEDIATRICS ◽

10.1542/peds.92.5.710 ◽

1993 ◽

Vol 92 (5) ◽

pp. 710-714 ◽

Cited By ~ 1

Author(s):

Kathleen B. Weatherstone ◽

Lynn B. Rasmussen ◽

Allen Erenberg ◽

Emily M. Jackson ◽

Katherine S. Claflin ◽

...

Keyword(s):

Vital Signs ◽

Behavioral Changes ◽

Controlled Study ◽

Topical Anesthetic ◽

Double Blind ◽

Safety And Efficacy ◽

Exact Test ◽

Treatment Groups ◽

Topical Lidocaine ◽

Postoperative Serum

Objective. Circumcision is a common neonatal surgical procedure routinely performed without the use of anesthesia. The purpose of this study was to evaluate the safety and efficacy of topical lidocaine cream as an anesthetic for circumcision. Methods. Thirty newborns were studied in a randomized, double-blind, placebo-controlled study; 15 received a topical 30% lidocaine cream and 15 received the cream base alone. Vital signs were recorded, and preoperative and postoperative serum β-endorphin and lidocaine concentrations were measured. A videotape of the newborn was used to score behavioral changes. Results. Comparisions of the vital signs precircumcision and postcircumcision showed no differences between the placebo and treatment groups, with the exception of mean systolic blood pressure, which significantly increased in the placebo-treated newborns (P < .05). Serum β-endorphin concentrations increased postoperatively in 11 of 15 subjects receiving placebo, but decreased or remained unchanged in 10 of 15 subjects receiving lidocaine (P = .03, Fisher's exact test). When stress-related behaviors in the precircumcision and post-circumcision periods were compared, the mean increase in their occurrence was greater in the placebo than in the treatment group. There was no significant absorption of lidocaine as measured in the serum. Conclusion. Topical application of a 30% lidocaine cream as used in this study may be a safe and efficacious anesthetic for circumcision.

Download Full-text