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Efficacy and Safety of Shugan Hewei Formula in the Treatment of Refractory Gastroesophageal Reflux Disease (Liver-stomach Disharmony): a Randomized Double-blind Placebo-controlled Clinical Study

Efficacy and Safety of Shugan Hewei Formula in the Treatment of Refractory Gastroesophageal Reflux Disease (Liver-stomach Disharmony): a Randomized Double-blind Placebo-controlled Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000133
Enrollment
Unknown
Registered
2025-01-16
Start date
2025-02-11
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Refractory gastroesophageal reflux disease

Interventions

Treatment group:Shugan Hewei Formula were taken orally one dose a day 2 bags in total 1 bag each time 1 hour in the morning and evening after meals for 8 weeks
Placebo control group:Shugan Hewei Formula with 10% content were taken orally one dose a day 2 bags in total 1 bag each time 1 hour in the morning and evening after meals for 8 weeks

Sponsors

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the Western diagnostic criteria for refractory gastroesophageal reflux disease; 2. It meets the diagnostic criteria of TCM syndrome of liver and stomach disharmony; 3. Age =18 and =80 years old gender is not limited; 4. Voluntarily participate in this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe gastrointestinal diseases: peptic ulcer history of gastroesophageal and duodenal surgery Zhuoyi syndrome primary esophageal motility gastrointestinal malignancy etc.; 2. Serious primary diseases of heart-brain liver lung kidney blood endocrine and other important systems; 3. Persons with severe mental illness; 4. Those who cannot take medicine during pregnancy pregnancy or lactation; 5. Allergic to the drugs used in this study; 6. Participants who took the same drug treatment regimen as the study before enrollment; 7. People participating in or within 4 weeks of clinical trials of other drugs.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Score;

Secondary

MeasureTime frame
Esophageal Hypervigilance and Anxiety Scale-7;Patient Health Questionnaire-9;Visceral Sensitivity Index;?-Aminobutyric Acid;TCM syndrome score scale;glutamine;glutamate;

Countries

CHINA

Contacts

Public ContactFANG Shengquan

Yueyang Hospital of Integrative Medicine Shanghai University of Traditional Chinese Medicine

fsq2032003@163.com18930566355

Outcome results

None listed

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