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ShuGanHeWei Decoction in the treatment of refractory gastroesophageal reflux disease: a randomized parallel controlled clinical study

ShuGanHeWei Decoction in the treatment of refractory gastroesophageal reflux disease: a randomized parallel controlled clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17010669
Enrollment
Unknown
Registered
2017-02-17
Start date
2017-02-17
Completion date
Unknown
Last updated
2017-04-18

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:ShuGanHeWei granule, dissolve with warm water, two times oral daily, each time 100ml, eight weeks course of treatment
control group:Ray Bella with enteric coated tablets: each 10mg, two times a day orally for eight weeks.

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. symptoms related with gastroesophageal reflux disease, such as heartburn, vomiting stomach acid, retrosternal pain, prostrate cough, pharynx Laryngeal discomfort, GERDQ score more than 8 points; 2. endoscopy or pH and impedance monitoring for 24 hours to identify gastroesophageal reflux disease within 6 months; 3. Taking the standard dose of first generation PPI (omeprazole, lansoprazole, Pantoprazole)for 4 weeks with failure; 4. clear consciousness, subjective expression of discomfort; 5. 18-70 years of age, male and female.

Exclusion criteria

Exclusion criteria: 1. with one of the following diseases: peptic ulcer, esophageal and gastric or duodenal surgery, Zollinger Ellison syndrome, primary esophageal motility disorders (such as achalasia, scleroderma, primary esophageal spasm), upper gastrointestinal malignant lesions, drug esophagitis and psychiatric patients; 2. long-term use of other drugs for gastroesophageal reflux disease, and having not stopped a month before the study; 3. pregnant women and lactating women; 4. patients with severe cardiovascular disease or liver and kidney dysfunction (the numbers of AST, ALT, creatinine are more than one and a half times as the normal range); 5. those who can not understand the treatment or can not take medicine and the relevant inspectors on time; 6. researchers of the study.

Design outcomes

Primary

MeasureTime frame
blood test;urine test;stool test;liver function;renal function;ECG;electronic gastroscope;Gastric mucosa pathology;Clinical symptom score;SF-36 score;

Countries

China

Contacts

Public ContactShengLiang Zhu

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

zhushengliang999@163.com+86 13611947064

Outcome results

None listed

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