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

Authors
Category Primary study
Registry of TrialsInternational Traditional Medicine Clinical Trial Registry
Year 2026
INTERVENTION: 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 water and taken in two equal portions, 150ml each, before meals, once in the morning and once in the evening. (Uniformly produced by Jiangyin Tianjiang Pharmaceutical Co., Ltd. as formula granules) The ingredients include Bupleurum, White Peony, Prepared Licorice, Raw Licorice, and other 10 herbs. (This formula is currently under patent application, so the full list of ingredients and dosages is not disclosed.) Aluminum magnesium carbonate chewable tablets (simulants) (uniformly produced by) are taken orally, 1g each time, 30 minutes before meals, three times daily.;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 in 300ml of boiling water and taken in two equal portions, 150ml each time, before meals, once in the morning and once in the evening.Aluminum Magnesium Carbonate Chewable Tablets are taken orally, 1g per dose, 30 minutes before meals, three times daily.; CONDITION: Biliary reflu Xgastritis PRIMARY OUTCOME: Improvement rate of bile reflux under gastroscopy.; SECONDARY OUTCOME: Endoscopic severity of mucosal inflammation;TCM Syndrome Score;blood indicators; 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 reflu Xgastritis as specified in the "Consensus Opinion on Chinese Chronic Gastritis" (2017), with confirmed evidence of bile reflu Xvia 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 th
Epistemonikos ID: 67311fc37b56147ea198b0da00e0fc2cacfba62b
First added on: May 09, 2026