Shuganhewei Recipe for Refractory Gastroesophageal Diseases with Qi Stagnation and Phlegm Stagnation: A Randomized, Parallel-Controlled Study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200061651

Enrollment

Unknown

Registered

2022-06-30

Start date

2022-06-16

Completion date

Unknown

Last updated

2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory gastroesophageal disease

Interventions

Test group:Shuganhewei Decoction combined with Vonoprazan Fumarate

Control group:Vonoprazan Fumarate

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of vomiting acid disease (gastroesophageal disease) with qi stagnation and phlegm obstruction; 2. Patients who failed to take double dose PPI for 8 weeks before participating in this study; 3. Aged 18 - 70 years, male or female; 4. Understand and agree to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with one of the following diseases: peptic ulcer, history of gastroesophageal and duodenal surgery, Zollinger-Ellison syndrome, primary esophageal motility diseases (such as achalasia, scleroderma, primary esophageal spasm), upper gastrointestinal malignant lesions, coronary heart disease, diabetes, drug-induced esophagitis; 2. Long-term use of anticoagulant drugs and severe coagulopathy; 3. Nasal deformity, recent nasopharyngeal surgery can not be 24h pH-impedance monitoring, esophageal high-resolution manometry; 4. Pregnant or lactating women; 5. Known to be allergic to the composition of traditional Chinese medicine used in this study or vorazol fumarate tablets; 6. Participated in other clinical studies or are participating in other clinical investigators 1 month before enrollment; 7. Patients treated with different dosage forms of Chinese herbal medicine or vonoprazan fumarate 1 month before enrollment.

Design outcomes

Primary

Measure	Time frame
Electronic gastroscope;Esophageal High Resolution Manometry;Esophageal 24-hour pH-impedance monitoring;Clinical Symptom Observation Form;Quality of Life (SF-36);	—

Secondary

Measure	Time frame
Clinical symptom score;Gastroesophageal questionnaire (GerdQ);Somatization symptom checklist (SSS);	—

Countries

China

Contacts

Public ContactFang Shengquan

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

fsq20032003@163.com+86 18930566355

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026