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A randomized, double-blind and double-dummy controlled trail of Hewei Jiangni Decoction in the treatment of nonerosive gastroesophageal reflux disease(cold and heat mixed syndrome)

A randomized, double-blind and double-dummy controlled trail of Hewei Jiangni Decoction in the treatment of nonerosive gastroesophageal reflux disease(cold and heat mixed syndrome)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005560
Enrollment
Unknown
Registered
2022-01-29
Start date
2018-12-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Nonerosive gastroesophageal reflux disease

Interventions

The treatment group:Hewei Jiangni Decoction + dummy omeprazole
The control group:dummy Hewei Jiangni Decoction granules + omeprazole

Sponsors

Dongfang Hospital of Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) patients who met the diagnostic criteria of Western medicine; (2) aged 18-65 years; (3) not receiving acid-inhibitory drugs or gastric mucosal protective agents within 2 weeks; (4) exclude other gastrointestinal diseases by gastroscopy to confirm NERD; (5) voluntarily participated in this study, written informed consent.

Exclusion criteria

Exclusion criteria: (1) patients with reflux esophagitis, reflux hypersensitivity and Barrett's esophagus; (2) patients with a history of upper gastrointestinal bleeding or surgery, esophageal stenosis, esophageal and gastric tumors, and other organic lesions; (3) patients with cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic system and other serious primary diseases; (4) lactating and pregnant women; (5) patients with a history of mental or neurological disorders or those who are difficult to complete; (6) patients currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
GERD - Q scale integral;TCM syndrome scale integral;SF36 scale integral;PRO scale integral;

Countries

China

Contacts

Public ContactChune Xie
xiechune@sina.com13651014735

Outcome results

None listed

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