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A multicenter randomized double-blind placebo-controlled clinical study of Tongxia granules (liver clearing and gastric method) in the treatment of non-erosive reflux disease hepatogastric depression syndrome

A multicenter randomized double-blind placebo-controlled clinical study of Tongxia granules (liver clearing and gastric method) in the treatment of non-erosive reflux disease hepatogastric depression syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000160
Enrollment
Unknown
Registered
2025-01-25
Start date
2020-09-01
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

Nonerosive reflux disease

Interventions

Control group:placebo
Treatment group:Tongjiang granules

Sponsors

Wuhan No.1 Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Meet NERD Western medical diagnostic criteria; 2) Patients with poor treatment effect of antacids; 3) Be between the ages of 18-70 years; 4) Meet the diagnostic criteria of TCM hepatic and gastric depression syndrome; 5) The patient has informed consent and is willing to accept the corresponding treatment.

Exclusion criteria

Exclusion criteria: 1) Patients with active peptic ulcer gastrointestinal bleeding severe dysplasia of the gastric mucosa or suspected malignant transformation patients with bradycardia or postoperative patients with cardia failure; 2) Have other organic diseases of the digestive system (such as acute and chronic pancreatitis liver cirrhosis etc.) or systemic diseases that affect the motility of the digestive tract (such as: hyperthyroidism diabetes chronic renal insufficiency psychiatric and nervous system lesions etc.); 3) Patients with serious lesions of major organs such as heart liver and kidney hematopoietic system diseases and tumors; 4) Pregnant and lactating women; 5) History of neurological and psychiatric diseases; 6) Those who have a history of allergy to the drugs used; 7) Subjects who are participating in other clinical trials or within 4 weeks.

Design outcomes

Primary

MeasureTime frame
Acid reflux,heartburn symptom score;

Secondary

MeasureTime frame
Self-rating scale for anxiety and depression;TCM syndrome score;GERD-HRQL;Secondary symptom score(chest pain;upper abdominal pain etc);Chronic gastrointestinal disease PR0 scale;

Countries

China

Contacts

Public ContactShi Zhaohong

Wuhan No.1 Hospital

zhaohshi@126.com+86 186 7409 3621

Outcome results

None listed

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