Randomized Controlled Clinical Trial Article Writing

Title Page

Article Title: Should be concise and clearly reflect the core issues and methods of the study.

Author Names and Affiliations.

Corresponding Author Contact Information.

Keywords (3-5 keywords for indexing and searching purposes).

Abstract

##Background: A brief introduction to the background and purpose of the study.

Methods: Description of the study design, randomization methods, interventions, and main outcome assessment indicators.

Results: A brief report of the main results, including statistical significance and effect size, etc.

Conclusion: Conclusions based on the results and their clinical significance.

Word Limit: Typically around 250 words.

Keywords

3-5 keywords.

Main Text

1. Introduction

Background Information: An overview of the background of the research field, highlighting the significance of the study.

Research Question: Clearly state the scientific question or hypothesis to be addressed.

Objectives and Hypotheses: Clarify the research objectives and propose research hypotheses.

2. Methods

2.1 Study Design:

Briefly describe the study design (e.g., double-blind, parallel groups, randomized controlled trial, etc.).

Participants:

Inclusion and Exclusion Criteria.

Source of Study Subjects (e.g., hospitals, communities, volunteers, etc.).

Ethical Considerations (including patient informed consent, hospital ethics approval).

Registration Number

2.2 Interventions:

Describe the content and implementation of interventions for the experimental and control groups.

Dosage, frequency, and duration of the interventions, etc.

2.3 Randomization Methods: Describe the randomization procedures, including the generation of randomization lists, allocation concealment, and blinding.

Blinding: Explain whether blinding is used (single-blind, double-blind, etc.) and how it is implemented.

2.4 Primary and Secondary Outcomes:

Clearly list the primary and secondary clinical outcome measures.

Assessment tools and measurement methods (e.g., questionnaires, biomarker detection, etc.).

Follow-up and Dropout: Detailed description of follow-up plans, dropout situations, and handling methods.

2.5 Statistical Analysis:

Describe the statistical methods, explaining the primary and secondary analysis approaches.

Show how to handle dropouts, missing data, and bias.

Sample size calculation methods and rationale.

3. Results

3.1 Participant Characteristics: Briefly describe the basic demographic characteristics of the intervention and control groups, ensuring comparability between groups. Indicate the location of the participant flow diagram.

3.2 Primary Outcomes: Present the primary outcome measures, using appropriate statistical analysis methods, such as effect size, confidence intervals, P-values, etc.

3.3 Secondary Outcomes: Describe secondary outcomes and their statistical analysis.

3.4 Subgroup Analysis and/or Interaction Effects.

3.5 Side Effects and Adverse Reactions: Report any side effects or adverse reactions that occurred during the study.

4. Discussion

4.1 Main Findings: Summarize the main findings of the study and compare them with existing literature.

4.2 Clinical Significance: Explain the potential impact of these findings on clinical practice.#### Mainly focusing on the similarities and differences between the main results and previous studies, as well as the main innovations of this study.

4.3 Limitations: Discuss the limitations of the study, including methodological limitations, sample size restrictions, etc.

4.4 Conclusion: Briefly summarize the conclusions of the study and propose recommendations for clinical practice. Sometimes, it can also emphasize the clinical value of the study and future research directions.

5. Acknowledgements

Gratitude towards funding sources, assistants, research participants, etc.

6. Conflict of Interest Statement

Clearly state the potential conflicts of interest for all participants.

7. References

A reference list formatted according to journal requirements.

8. Appendix (if applicable)

Additional materials or supplementary data for the study (e.g., intervention manuals, questionnaires, etc.).