Acknowledgements
We would like to thank teacher Du Liang of Sichuan Huaxi Hospital for his theoretical guidance on this subject.
Author contributions
XW contributed to study concept and design. XW and SL wrote the first draft of the protocol manuscript. FW and YW supervised the process. YW and CP revised the manuscript after feedback from all authors. DH and SS coordinate the conducting of this study. All authors reviewed the manuscript and approved the final version of the manuscript.
Funding
This study is supported by the Key R&D Program of Sichuan Provincial Department of Science and Technology (Number 2020YFS0312, 19ZDYF0611) and Sichuan Province Health Research Project (Number 20PJ160). Funding agency does not have any role in the study design, data collection, data analysis or publication of results. Sponsor contact name: Zhenxing Wang, Address: No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, P.R. China. Telephone: +8619108201441, Email: [email protected]. The sponsor played no part in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication.
Availability of data and materials
Data sharing is not applicable to this article as no datasets are reported. The full protocol of this study will be provided by the corresponding author. The paper reporting the research results will disclose the availability of the data sets generated in the research. Upon reasonable request, the author can access the complete agreement and model consent form.
Ethics approval and consent to participate
The Chinese Ethics Committee of Registering Clinical Trials reviewed this study protocol and gave its approval and consent on 31 October 2020 (Ethical Review No.: ChiECRCT20190343). We ensure that written informed consent will be obtained from all study participants.
Consent for publication
Not applicable.
Competing interests
The authors declare that they have no competing interests.
Voluntary Subject Statement:
I have learned about the requirements of the clinical study in detail and the potential adverse reactions associated with it. I voluntarily participate in this clinical study, receive treatment on time, and fill out the relevant health questionnaire in accordance with the requirements of the research program. If adverse reactions occur, I will report to the doctor promptly. At the same time I know that the doctor will give positive response for my possible adverse reactions. I am also entitled to withdraw from the study at any time for any reason. However, if there are no special circumstances, I will cooperate with the doctor to complete the clinical study. My participation and the personal data in the trial are confidential. I agree with my doctor, the relevant regulatory authorities, and the ethics committee to review my information as required.
I (signature) relative (signature) (Relationship)
Date: D M Y
Doctor's declaration
I have fully explained the requirements of the clinical study in detail and the potential adverse reactions to the above participant/relative, and answered their questions. To the best of my knowledge, the participant/relative has been informed adequately and has consented.
Doctor’s signature: Date: D M Y
In the event of inconsistency or discrepancy between the Chinese version and the English version, the Chinese language version shall prevail.
Ethical approval document
Ethics Review Report of China Registered Clinical Trial Ethics Committee
Research topic: Clinical study of Th1/Th2 balance drift and Omega-3 fatty acid intervention in people with high PM2.5 exposure in Chengdu subway station hall
Applicant reviewer: Shuiqin Li
Tel: 18628912226
Email: [email protected]
Applicant review unit: Affiliated Hospital of Chengdu University of Traditional Chinese Medicine Ethics review number: ChiECRCT20190343
This ethics committee is in accordance with the "Measures for the Ethical Review of Biomedical Research Involving People (Trial)" by the Health and Family Planning Commission of the People's Republic of China (formerly the Ministry of Health) (Health Science Education Fa [2007] No. 17), the Declaration of Helsinki v.08 and the "International Ethical Guidelines for Human Biomedical Research" on the clinical trial submitted by Deputy Chief Physician Shuiqin Li of the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine for ethical review "The Th1/Th2 balance drift and Omega-3 fatty acid intervention in people with high PM2.5 exposure in Chengdu subway station hall "Clinical Research" to be reviewed, and the report is as follows:
The review experts of this ethics committee believe that the safety risk of the study is low for the test participants; the management and control measures of the research team for potential adverse reactions meet the requirements of GCP; the informed consent process is reasonable; the trial adopts a randomized controlled design and meets the research purpose.
Therefore, the research is in line with medical research ethics and agreed to be implemented according to the protocol (version number 2.0).
Funding document
Declaration number:20ZDYF1190 Plan number:2020YFS0312 Secret level
Task contract of Science and Technology Plan Project in Sichuan Province
Type of plan: key R & D projects
Project name:Nasal microflora-intestinal microflora-host interaction and the regulation mechanism of Ganduqing: a randomized, double-blind, placebo-controlled clinical study in Chengdu PM2.5 high-exposure population
Applicant: Chengdu University of traditional Chinese Medicine
Project leader: Zhenxing Wang
Contact number:028-86691467
Recommended unit:Department of Education of Sichuan Province
Project funding: 20 ($30,000)
Project start and end date:2020.01.01-2021.12.31
Declaration number:19ZDYF Plan number:2019YFS0083 Secret level
Task contract of Science and Technology Plan Project in Sichuan Province
Type of plan: key R & D projects
Project name:Nasal microflora-intestinal microflora-host interaction and the regulation mechanism of Ganduqing: a randomized, double-blind, placebo-controlled clinical study in Chengdu PM2.5 high-exposure population
Applicant: Chengdu University of traditional Chinese Medicine
Project leader: Fei Wang
Contact number:028-86691569
Recommended unit:Department of Education of Sichuan Province
Project funding: 50 ($76,000)
Project start and end date:2019.01.01-2021.12.31
Declaration number:20PJ160 Plan number:20PJ160 Secret level