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A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Digan Zhaoshao Decoction for the Treatment of Bile Reflux Gastritis

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Digan Zhaoshao Decoction for the Treatment of Bile Reflux Gastritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000902
Enrollment
Unknown
Registered
2026-04-03
Start date
2026-04-13
Completion date
Unknown
Last updated
2026-04-28

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

Conditions

Biliary reflux gastritis

Interventions

Experimental Group:The formula granules of Danggui Sini Decoction are taken once daily, containing 10 small packets of formula granules. After mixing evenly, they are dissolved in 300ml of boiling wat
Control Group:The herbal formula granules of Er-Gan-Zhi-Shao Decoction,simulated agent, are taken once daily, containing 10 small packets of formula granules. After mixing uniformly, it is dissolved i

Sponsors

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: In accordance with the "Consensus Opinion on Chinese Chronic Gastritis" (2017) by the Working Group on Chronic Gastritis of the Chinese Society of Gastroenterology and the "Expert Consensus on the Diagnosis and Treatment of Chronic Gastritis in Traditional Chinese Medicine" (2023) by the Subcommittee of Diseases of the Chinese Association of Traditional Chinese Medicine, the inclusion criteria are as follows: 1. Meets the diagnostic criteria for biliary reflux gastritis as specified in the "Consensus Opinion on Chinese Chronic Gastritis" (2017), with confirmed evidence of bile reflux via endoscopic examination and inflammatory changes in the gastric mucosa. 2. Meets the diagnostic criteria for traditional Chinese medicine (TCM) diseases as specified in the "Expert Consensus on the Diagnosis and Treatment of Chronic Gastritis in Traditional Chinese Medicine" (2023), falling under the categories of "gaotong (stomach pain)," "gaopi disease (stagnation of qi in the stomach)," and "noisy stomach." The primary symptoms include epigastric pain (distending pain, dull pain, burning pain, stabbing pain, with or without tenderness), upper abdominal distension, or a burning sensation, accompanied by symptoms such as emotional distress, acid regurgitation, gastric burning, and belching. 3. Age between 18 and 70 years, with no restriction on gender. 4. Patients have signed an informed consent form, voluntarily participating in this study and agreeing to follow-up.

Exclusion criteria

Exclusion criteria: 1.Patients with peptic ulcers, gastric tumors, or other severe gastric diseases; 2. Patients with cirrhosis, acute cholecystitis, or other severe hepatobiliary or pancreatic diseases; 3. Patients with severe cardiovascular, cerebrovascular, hepatic, or renal diseases involving major organs; 4. Pregnant or breastfeeding women; 5. Patients with a history of allergies, such as allergies to two or more drugs or foods, or known allergy to the study drug; 6. Patients who have used medications affecting gastrointestinal motility or gastric mucosal protection, which may impact the evaluation of the study's efficacy, within the past two weeks; 7. Patients with mental disorders or poor compliance, making it impossible to complete the study; 8. Legally defined disabled patients (blindness, deafness, mutism, intellectual disabilities, mental disorders, physical disabilities); 9. Patients with a suspected or confirmed history of alcohol or substance abuse.

Design outcomes

Primary

MeasureTime frame
Improvement rate of bile reflux under gastroscopy.;

Secondary

MeasureTime frame
Endoscopic severity of mucosal inflammation;TCM Syndrome Score;blood indicators;

Countries

China

Contacts

Public ContactLi Zhe

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

lizhe@bjzhongyi.com15501152699

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026