Evidence map›Paper›PMID 30082340›Full record

ArticleBMJ open2018

Single-arm, open-label, dose-escalation phase I study to evaluate the safety of a herbal medicine SH003 in patients with solid cancer: a study protocol.

Chunhoo Cheon, Sohyeon Kang, Youme Ko, Mia Kim, Bo-Hyoung Jang, Yong-Cheol Shin, Seong-Gyu Ko

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03081819 (A Phase I Study of SH003 for Evaluate Safe Dose Range in Patients With Solid Cancer), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT03081819 phase1completednot on this map

A Phase I Study of SH003 for Evaluate Safe Dose Range in Patients With Solid Cancer

TypeinterventionalSponsorKyunghee University Medical CenterRan2017 to 2019Enrolled11ConditionsSolid Tumor, AdultArmsSH003
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Review
  2. Article
  3. Analgesic Effect of SH003 andCurrent issues in molecular biology · 2022
    Article
  4. General Use of Chinese Herbal Products among Female Patients with Mastitis in Taiwan.Evidence-based complementary and alternative medicine : eCAM · 2022
    Article
  5. Herbal Prescription SH003 Alleviates Docetaxel-Induced Neuropathic Pain in C57BL/6 Mice.Evidence-based complementary and alternative medicine : eCAM · 2021
    Article
  6. Article
  7. Article
  8. Article
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

7 authors.

Chunhoo CheonDepartment of Korean Preventive Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.
Sohyeon KangDepartment of Korean Preventive Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.
Youme KoDepartment of Korean Preventive Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.
Mia KimDepartment of Cardiovascular and Neurologic Disease (Stroke Center), College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.
Bo-Hyoung JangDepartment of Korean Preventive Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.
Yong-Cheol ShinDepartment of Korean Preventive Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.
Seong-Gyu KoDepartment of Korean Preventive Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCancer is a major health problem worldwide and the leading cause of death in many countries. The number of patients with cancer and socioeconomic costs of cancer continues to increase. SH003 is a novel herbal medicine consisting of METHODS AND ANALYSIS: This study is an open-label, dose-escalation trial evaluating the safety and tolerability of SH003. The traditional 3+3 dose-escalation design will be implemented. Patients with solid cancers will be recruited. According to dose level, the patients will receive one to four tablets of SH003, three times a day for 3 weeks. Toxicity will be evaluated using common terminology criteria for adverse events (CTCAE). Dose-limiting toxicities are defined as grade 3 or higher adverse events based on CTCAE. The maximum tolerated dose will be determined by the highest dose at which no more than one of six patients experiences dose-limiting toxicity. ETHICS AND DISSEMINATION: This study has been approved by the institutional review board of the Ajou University Hospital (reference AJIRB-MED-CT1-16-311). The results of this study will be disseminated through a scientific journal and a conference. TRIAL REGISTRATION NUMBER: NCT03081819; Pre-results.

Indexed as

AngelicaAntineoplastic Agents, PhytogenicAstragalus PlantClinical Trials, Phase I as TopicDose-Response Relationship, DrugHumansNeoplasmsPlant ExtractsTrichosanthesAntineoplastic Agents, PhytogenicPlant ExtractsSH003 extractclinical trialscomplementary medicineherbal medicineoncology

Identifiers

PMID30082340
PMCPMC6078237

What OpenQuestion holds

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Registered trials

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.