Evidence map›Paper›PMID 33145451›Full record

ArticleContemporary clinical trials communications2020

Evaluation of efficacy and safety of a novel lipogel containing diclofenac: A randomized, placebo controlled, double-blind clinical trial in patients with signs and symptoms of osteoarthritis.

Amit Bhatia, Vijay Goni, Shruti Chopra, Bhupinder Singh, Om Prakash Katare

Abstract read
In one paragraph

Article in Contemporary clinical trials communications, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Amit BhatiaDepartment of Pharmaceutical Sciences and Technology, Maharaja Ranjit Singh Punjab Technical University, Badal Road, Bathinda, Punjab, 151 001, India.
Vijay GoniDepartment of Orthopaedic Surgery, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh, 160 012, India.
Shruti ChopraAmity Institute of Pharmacy, Amity University, Sector 125, Noida, Uttar Pradesh, 201 303, India.
Bhupinder SinghUniversity Institute of Pharmaceutical Sciences, Panjab University, Sector 14, Chandigarh, 160 014, India.
Om Prakash KatareUniversity Institute of Pharmaceutical Sciences, Panjab University, Sector 14, Chandigarh, 160 014, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEffectiveness and safety of pharmaceuticals is the prime concern of every osteoarthritis (OA) treatment. Chronic administration of NSAIDs, especially in case of geriatrics, through oral route tend to compromise the patient's safety, whereas topical treatments are not found to be effective owing their poor ability to deliver drug molecules.Thus, the present study deals with a randomized, double-blind, controlled trial conducted on patients with knee osteoarthritis (OA) for comparing the performance of a novel topical gel (liposomal gel) of diclofenac with a placebo and a marketed gel.

methodsThe patients were treated and evaluated for 6 weeks as per the Western Ontario McMaster Universities (WOMAC) Index for OA. Patients were also observed for any adverse events. All the results were analyzed statistically using Kruskal-Wallis test, followed by Student's t-test at p ≤ 0.05.

resultsPatients treated with liposomal gel showed statistically significantly improvements in treatment in comparison to the other tested formulations. All the treatments were found to be well tolerated with no report of adverse event. The results unequivocally demonstrated the superiority of the diclofenac liposomal gel, in the relieving the symptoms of OA of the knee, in comparison to placebo and marketed gel.

conclusionFrom above results it was revealed that the drug in liposome have higher therapeutic potential. Thus, this can be a safe and effective option for the management of chronic OA especially for geriatric patients.

Indexed as

EfficacyLiposomeNanomedicineOsteoarthritisPatient complianceTopical drug delivery

Identifiers

PMID33145451
PMCPMC7593528

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.