Evidence map›Paper›PMID 32664084›Full record

Trial reportMedicine2020

A 12 week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of HT083 on mild osteoarthritis.

Donghun Lee, Seok Jung Kim, Hocheol Kim

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 23% of its field
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 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Non-Chinese herbal medicines for functional dyspepsia.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Trial
  3. Aromatic Plants as Potential Resources to Combat Osteoarthritis.Combinatorial chemistry & high throughput screening · 2024
    Review
  4. Review
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

3 authors at 3 institutions in 2 countries.

Donghun LeeDepartment of Herbal Pharmacology, College of Korean Medicine, Gachon University, Seongnam.ORCID 0000-0003-1075-0713
Seok Jung KimDepartment of Orthopedic Surgery, College of Medicine, The Catholic University of Korea.
Hocheol KimDepartment of Herbal Pharmacology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.ORCID 0000-0002-6690-0226
Gachon University · KRKyung Hee University · KRS.P.E.C.I.E.S. · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe increasing prevalence of osteoarthritis among the old population worldwide is a great concern. Two of the biggest complaints of OA patients are joint pain and inflammation. Currently, people are relying on non-steroidal anti-inflammatory drugs (NSAIDs) and steroids to control pain and inflammation. However, long-term use of these pharmaceutical drugs has negative health consequences in the elderly, including gastro-intestinal, respiratory, and renal diseases. Natural products are receiving more attention than ever as alternative treatments against OA for their efficacies and safety. The root of Paeonia lactiflora Pal and the gum resin of Commiphora myrrha have been used as analgesics and anti-inflammatory agents since ancient time. A new herbal formula composed of P. lactiflora root and C. myrrha gum resin extracts, known as HT083, has shown promising antinociceptive and anti-inflammatory effects in a rodent model of OA. We design this study to investigate the safety and the efficacy of HT083 to prevent OA in patients with mild OA.

methodsThis is a randomized, double-blind, and placebo-controlled study. A total of 100 eligible participants will be divided into two groups and will be given HT083 and a placebo for 12 weeks in 1:1 ratio. Treatment results will be assessed using a visual analog scale (VAS), Korean-Short Form health survey-36 score (SF-36), personal evaluation, and laboratory analysis. DISCUSSION: This trial is expected to provide clinical evidence on the effectiveness and the safety of HT083 as a natural treatment for mild OA.

trial registrationKorean Clinical Research Information Service (CRIS) number KCT0004925 Registered on 2020.04.16.

Indexed as

AdultAgedAnalgesicsAnimalsAnti-Inflammatory AgentsArthralgiaCommiphoraDouble-Blind MethodFemaleHumansIndolesInflammationMaleMedicine, Chinese TraditionalMiddle AgedOsteoarthritis, KneeAnalgesicsAnti-Inflammatory AgentsIndolesPlacebosPyrrolestoceranib phosphate

Identifiers

PMID32664084
PMCPMC7360256
OpenAlexW3040911851

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.