Here is the design of a clinical trial:

Official Title: Efficacy and Safety of Hou Gu Mi Xi in Patients With Peptic Ulcer Diseases: A Multicenter, Randomized, Double-blinded, Controlled Trial

Included conditions:
- Peptic Ulcer Disease

Study Armgroups:
- {'label': 'Hou Gu Mi Xi', 'type': 'EXPERIMENTAL', 'description': 'Basic treatment period (0 to 2rd week): Patients with infection of Helicobacter pylori receive rabeprazole (once 20 mg, twice a day), bismuth potassium citrate (once 0.3 g, twice a day), amoxicillin (once 1 mg, twice a day), and furazolidone (once 0.1 g, twice a day), and patients without infection of Helicobacter pylori only receive rabeprazole (once 20 mg, twice a day) and bismuth potassium citrate (once 0.3 g, twice a day).\n\nMaintain treatment period (3rd to 6th week): Patients in this arm receive Hou Gu Mi Xi (once 10 g, twice a day).\n\nRecuperation period (7th to 52th week): Patients in this arm receive Hou Gu Mi Xi (once 10 g, twice a day).\n\nExtensional observational period (53 to 104 weeks): no intervention.', 'interventionNames': ['Other: Hou Gu Mi Xi']}
- {'label': 'Hou Gu Mi Xi + rabeprazole', 'type': 'EXPERIMENTAL', 'description': 'Basic treatment period (0 to 2rd week): Patients with infection of Helicobacter pylori receive rabeprazole (once 20 mg, twice a day), bismuth potassium citrate (once 0.3 g, twice a day), amoxicillin (once 1 mg, twice a day), and furazolidone (once 0.1 g, twice a day), and patients without infection of Helicobacter pylori only receive rabeprazole (once 20 mg, twice a day) and bismuth potassium citrate (once 0.3 g, twice a day).\n\nMaintain treatment period (3rd to 6th week): Patients in this arm receive Hou Gu Mi Xi (once 10 g, twice a day) plus rabeprazole (once 10 mg, once a day).\n\nRecuperation period (7th to 52th week): Patients in this arm receive Hou Gu Mi Xi (once 10 g, twice a day).\n\nExtensional observational period (53 to 104 weeks): no intervention.', 'interventionNames': ['Other: Hou Gu Mi Xi', 'Drug: Rabeprazole']}
- {'label': 'Placebo + rabeprazole', 'type': 'PLACEBO_COMPARATOR', 'description': 'Basic treatment period (0 to 2rd week): Patients with infection of Helicobacter pylori receive rabeprazole (once 20 mg, twice a day), bismuth potassium citrate (once 0.3 g, twice a day), amoxicillin (once 1 mg, twice a day), and furazolidone (once 0.1 g, twice a day), and patients without infection of Helicobacter pylori only receive rabeprazole (once 20 mg, twice a day) and bismuth potassium citrate (once 0.3 g, twice a day).\n\nMaintain treatment period (3rd to 6th week): Patients in this arm receive Placebo of Hou Gu Mi Xi (once 10 g, twice a day) plus rabeprazole (10 mg/d, qd).\n\nRecuperation period (7th to 52th week): Patients in this arm receive Hou Gu Mi Xi (once 10 g, twice a day).\n\nExtensional observational period (53 to 104 weeks): no intervention.', 'interventionNames': ['Other: Placebo', 'Drug: Rabeprazole']}
- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Basic treatment period (0 to 2rd week): Patients with infection of Helicobacter pylori receive rabeprazole (once 20 mg, twice a day), bismuth potassium citrate (once 0.3 g, twice a day), amoxicillin (once 1 mg, twice a day), and furazolidone (once 0.1 g, twice a day), and patients without infection of Helicobacter pylori only receive rabeprazole (once 20 mg, twice a day) and bismuth potassium citrate (once 0.3 g, twice a day).\n\nMaintain treatment period (3rd to 6th week): Patients in this arm receive placebo of Hou Gu Mi Xi (once 10 g, twice a day).\n\nRecuperation period (7th to 52th week): Patients in this arm receive Hou Gu Mi Xi (once 10 g, twice a day).\n\nExtensional observational period (53 to 104 weeks): no intervention.', 'interventionNames': ['Other: Placebo']}

Interventions:
- {'type': 'OTHER', 'name': 'Hou Gu Mi Xi', 'description': 'Hou Gu Mi Xi is an oatmeal-liked, solid food (dry or dissolved eating).', 'armGroupLabels': ['Hou Gu Mi Xi', 'Hou Gu Mi Xi + rabeprazole']}
- {'type': 'OTHER', 'name': 'Placebo', 'description': 'The placebo is as same as Hou Gu Mi Xi in respect of color, taste, and smell.', 'armGroupLabels': ['Placebo', 'Placebo + rabeprazole']}
- {'type': 'DRUG', 'name': 'Rabeprazole', 'description': 'Rabeprazole is produced by Shanghai Xinyi Pharmaceutical Corp. Ltd.', 'armGroupLabels': ['Hou Gu Mi Xi + rabeprazole', 'Placebo + rabeprazole'], 'otherNames': ['Trade name: Xin Wei An']}

Primary Outcomes:
- {'measure': 'Total effective rate', 'description': 'The ulcer was classified for 6 grades:\n\nA1: The ulcer is round or elliptical with the center covers thick and white fur; it can be accompanied by errhysis or blood clot, and was surrounded by the obvious flush, hyperemia and edema.\n\nA2: The ulcer is covered by yellow or white fur, no bleeding, alleviated congestion and edema H1: The ulcer is healing, no hyperemia and edema disappear around the ulcer; the ulcer moss becomes thin, subside, accompanied by the new capillaries.\n\nH2: The ulcer continuously changes to shallow and small. The surrounding mucosa plica centralized to the ulcer.\n\nS1: The white fur of ulcer disappears and the new ulcer mucosa presents red. S2: The new ulcer mucosa goes from red to white.\n\nClinical cure: The ulcer heals with or without scar Markedly effective: The healing of ulcer reaches grade H2, or improves 2 grades Effective: The healing of ulcer reaches grade H1, or improves 1 grades Non-effective: No efficacy by the endoscopic observation', 'timeFrame': 'At baseline, and 12, 26, 52, and 104 weeks'}
- {'measure': 'Quality of ulcer healing', 'description': "According to Pan et al's method, we will classify the quality of ulcer healing as three ranks by histological assessment: 1) good: integral villus and epithelium, many glands, good morphology, many blood capillary, and few inflammatory cells infiltration. 2) fair: short villus, incomplete or rough epithelium, less glands, structural distortion, few blood capillary, and moderate inflammatory cells infiltration; 3) poor: a little new epithelial cell, poor integrity of epithelium, poor morphology of villus and glands, very few blood capillary, and large amount of inflame cells.", 'timeFrame': 'At baseline and 12 and 26 weeks'}
- {'measure': 'Changes in Spleen Qi Deficiency Symptoms Grading and Quantifying Scale (unit: score on a scale)', 'description': 'This outcome will be assessed based on the Spleen Qi Deficiency Symptoms Grading and Quantifying Scale (SQD scale) score. Construct of SQD scale: A total of 15 items, of which 7 items assess main symptoms, including stomach pain, stomach distension, acid reflux, abdominal distension, powerless defecation, fatigue and weak, and inappetence; 8 items assess secondary symptoms, including stomach tightness, stomach burn, belching, nausea and vomiting, abnormal stool, tired mind and taciturnity, sallow complexion, and tastelessness and hypodipsia.\n\nScale ranges and explanations: Assessment of each item includes three aspects: degree, frequency in one day, and episodes within one week. The total score of each item is the sum of points of the three aspects. The higher score indicate the worse symptom. The items for assessing main symptoms are double weighted. The score range is 0 to 283 point.', 'timeFrame': 'At basline and 6, 12, 26, 52 and 104 weeks'}

Please estimate the sample size based on the assumption: 
type I error (Î±) of 0.05, type II error (Î²) of 0.2, and a maximum drop-out rate of 15%
2.9
        Sample size estimation
        The main objective of this trial is to assess the effects of HGMX compared with placebo on the total effective rate. Therefore, the sample size estimation is based on the formula for a superiority design.[24] Because there are no previous studies available for reference, we estimated a P of .85 (total effective rate in the two groups receiving HGMX) and a P0 of .65 (total effective rate in the 2 groups receiving placebo) according to the results of our pilot survey and expert opinions. In addition, we adopted a type I error (Î±) of 0.05, a type II error (Î²) of 0.2, and a maximum drop-out rate of 15%. Based on these assumptions and our funding constraints, we computed a sample size of 360, with 90 in each group.