Study design
The protocol version is 2.0 and the date is May 1, 2024. This study is a single-center randomized controlled trial evaluating the effects of JWXSD on FD. The trial will be performed at the Beijing University of Chinese Medicine, Beijing, China.Participants will be randomly assigned to three groups (JWXSD group, mosapride group and placebo group). The schedule of enrollment, interventions, and assessment is in Fig 1. The study will be reported according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. The flowchart of the trial design is shown in Fig 2. This study will be conducted twice by researchers from Dongfang Hospital for clinical study monitoring.
Sample size
The sample size was calculated for the primary outcome NDSI. Taking a two-sided significance level of 0.05 and power of 0.1. Considering a dropout rate of 20%, a total of 72 participants with FD will be enrolled in this study.
Participant and recruitment
The recruitment will be conducted at the Beijing University of Chinese Medicine. We will recruit participants through advertisements on the canteen and WeChat software. Eligible participants will be informed of the prospective benefits and potential risks of participation and will be presented with an informed consent form. Participants shall be considered successfully enrolled on the provision of a written informed consent form.
Randomization, allocation and blinding
Generate random sequences by statistical analysts, they were randomly divided into a JWXSD group, a mosapride group, and a placebo group. 24 participants per group. The randomization plan generated in this study was sealed by the personnel responsible for randomization and was randomly assigned by personnel who did not participate in this trial.
Inclusion criteria
1. Meet the diagnostic criteria of FD Rome III;
2. Aged 18-35;
3. Have not taken gastrointestinal motility drugs in the past two weeks;
4. Sign the informed consent form.
Exclusion criteria
1. Have other functional gastrointestinal diseases;
2. Suffering from serious diseases, such as severe cardiovascular and cerebrovascular diseases, diabetes, cancer, and excessive functional dyspepsia;
3. Participate in other ongoing clinical trials;
4. Unwilling to be randomized.
Interventions
Eligible participants will be assigned to the Jiao Wei Xiao Shi Decoction (JWXSD) group. The JWXSD (Charred hawthorn 30g, Charred malt 30g and Siraitia grosvenorii 30g) are provided by Beijing Tongrentang, which was founded in 1669. The traditional Chinese medicine will be added 300ml of water and administered orally every morning, middle and evening after meals for 8 weeks. The mosapride group will receive mosapride (5mg) 3 times a day for 2 weeks. The placebo capsules will be the same in terms of colour, smell, taste, usage and dosage of mosapride. The capsules will be manufactured by Beijing Zhongkang Weiye Health Food Co., Ltd.
Primary outcome
The primary outcome of this study is the Nepean Dyspepsia Symptom Index (NDSI). We will utilize NDSI to measure the frequency, intensity, and level of discomfort for 15 upper gastrointestinal symptoms. NDSI is a 16-item questionnaire and ranges from 0 to 208, with higher scores indicating worse symptoms. NDSI will be evaluated at week 1, 3, 4, 8, 12, 16.
Secondary outcomes
The Nepean Dyspepsia Life Quality Index (NDLQI), comprising 4 components: interference, knowledge/control, eat/drink, and sleep/disturb, will be employed to evaluate the life quality of FD patients. NDLQI is a 25-item questionnaire and ranges from 25 to 125, with higher scores indicating worse quality of life. Body Mass Index (BMI) will be evaluated by height and weight. The normal value of BMI is 18.5-24kg/m ². The Pittsburgh Sleep Quality Index (PSQI), comprises 7 components, including sleep duration, sleep latency, sleep efficiency, sleep medication use, sleep disturbances, subjective sleep quality, and daytime dysfunction. PSQI is a 19-item questionnaire and ranges from 0 to 21, with higher scores indicating worse quality of sleep. The NDLQI, BMI, and PSQI will be assessed at week 1, 3, 4, 8, 12, 16.
Adverse events and safety
The pulse, respiration, blood pressure, temperature, blood routine, and liver and kidney function tests will be performed before treatment and after 2 weeks of intervention. Immediately destroy blood samples after use. Adverse events should be documented in the CRF during the trial. In case of any serious adverse event during the study, the participants should be urgently unblinded and receive medication treatment. The researcher should be recorded in detail and complete the Serious Adverse Event Form.
In addition, any serious adverse event will be provided compensation.
Data collection and management
Data will be recorded on the written case report forms (CRFs). These data will include age, gender, occupation, weight, height, education level and medication history. Two managers will enter the data into a password-protected electronic database.
Statistical analysis
In this study, the statistical analysis plan will be performed by a statistician. Statistical analyses will be conducted using R4.3.1, SAS v9.4 and SPSS 26.0. Full analysis set (FAS), per-protocol set (PPS) and safety set (SS) will be applied in the data analysis. Quantitative data will be reported as mean, standard deviation, median, upper quartile, lower quartile, etc. Normally distributed data will be assessed using analysis of variance while the Kruskal Wallis H test will be calculated for non-normally distributed data between multiple groups. Categorical data will be expressed as examples and percentages. The chi-square tests will be used for group comparisons. A two-sided P value of 0.05 will be considered statistically significant.