First, the main points of the design:
Clarify the purpose of the study: Before starting a clinical trial, it is necessary to clarify the purpose of the study, such as evaluating the efficacy and safety of the intestinal hydrotherapy machine in patients with constipation.
Determine the type of study: Select the appropriate type of study according to the purpose of the study, such as randomized controlled trial, single-arm trial, etc.
Determine the test subjects: select subjects who meet the inclusion criteria and exclude those who are not eligible.
Determine the test method and observation indicators: According to the research purpose and study type, formulate reasonable test methods and observation indicators, such as the frequency, duration, symptom score of intestinal hydrotherapy, etc.
Develop a data collection and processing plan: During the trial, a large amount of data needs to be collected and processed, such as the basic information of the subjects, the process, the efficacy and safety, etc. A detailed data collection and processing plan needs to be developed to ensure the accuracy and reliability of the data.
Develop ethical and safety safeguards: In clinical trials, it is necessary to pay attention to ethical and safety issues and develop corresponding safeguards, such as informed consent, privacy protection, and adverse reaction handling.
Second, the implementation steps:
Research protocol formulation: According to the above design points, formulate a detailed research protocol, including research objectives, research types, test objects, test methods, observation indicators, data collection and processing plans, ethics and safety measures, etc.
Ethical review: Submit the research protocol to the Ethics Review Committee for review to ensure compliance with ethical principles and relevant regulatory requirements.
Subject recruitment and screening: Recruit and screen suitable subjects according to the inclusion criteria and exclusions in the study protocol.
Informed consent and subject registration: Subjects are given a detailed introduction to the study content and risks, and an informed consent form is signed. Eligible subjects are registered and numbered.
Randomization and control settings: According to the requirements of the type of study, subjects are randomly divided into experimental and control groups, and comparability between the two groups is ensured.
Pre-trial baseline assessment: Before the start of the trial, all subjects were evaluated at baseline, and basic information and pre-symptom scores were recorded.
Trial process management: In accordance with the requirements in the research protocol, the subjects in the experimental group were subjected to intestinal hydrotherapy, and the process and efficacy indicators were recorded. At the same time, attention is paid to the occurrence and treatment of adverse reactions.
Efficacy evaluation: In the process of **, the efficacy of the experimental group and the control group is evaluated according to the observation indicators, and methods such as scale evaluation and quality of life score can be used.
Data collection and processing: During the trial, collect and process data in a timely manner to ensure the accuracy and completeness of the data.
Statistical analysis: According to the purpose of the study and the type of study, statistical analysis of the data is carried out to draw conclusions.
Summary report writing: According to the statistical analysis results and the test process, write a summary report to summarize and analyze the research results.
It should be noted that in the process of clinical trials, it is necessary to comply with relevant regulations and ethical principles to ensure the rights and safety of subjects. At the same time, a sound quality control and data management plan needs to be developed to ensure the accuracy and reliability of the data.