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HeZhong JianPi Decoction in the treatment of gastroesophageal reflux disease: a randomized double-blind controlled clinical study and technique promotion

HeZhong JianPi Decoction in the treatment of gastroesophageal reflux disease: a randomized double-blind controlled clinical study and technique promotion

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17011302
Enrollment
Unknown
Registered
2017-05-04
Start date
2017-05-10
Completion date
Unknown
Last updated
2017-05-09

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

Conditions

gastroesophageal reflux disease

Interventions

Traditional Chinese medicine group:HeZhongJianPi decoction,two times oral daily, each time 100ml, eight weeks course of treatment
Western medicine group:omeprazole capsules: each 20mg, two times a day orally for eight weeks

Sponsors

Shanghai Municipal Hospital of Shanghai TCM University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patient with gastroesophageal reflux disease more than 1 months; 2. The total RDQ score (a + b) at least 12; 3. Male or female aged 18 to 70 years; 4. Did no receive any formal treatment for system related diseases, including the use of antacids (PPI), antacid (H2RA) and gastric motility drugs and traditional Chinese medicine. Voluntary or receiving a 1 week washout period, drug eluting including PPI, H2RA and gastric motility drug has an impact on the gastrointestinal function of drugs; 5. The voluntary participation in the trial, informed consent, and signed the agreement.

Exclusion criteria

Exclusion criteria: 1. The pregnant or lactating women; 2. The combination of the following diseases: suspected or proven malignant tumor, 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 disease, drug-induced esophageal inflammation, pyloric obstruction; 3. The serious cardiovascular disease, liver and kidney dysfunction; 4. There is or psychotic language disorder; 5. It is not partners (that cannot match the diagnosis or not according to the provisions of medication and influence curative effect).

Design outcomes

Primary

MeasureTime frame
RDQ;GERD-HRQL;

Secondary

MeasureTime frame
PSQI;HAD;

Countries

China

Contacts

Public ContactLingyun Zhu

Department of Gastroenterology, Shanghai Municipal Hospital of Shanghai TCM University

0914@szy.cn+86 18901909900

Outcome results

None listed

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