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Hedgehog Fungus Extract Granules in the treatment of chronic non-atrophic gastritis: A multi-center, randomized, placebo-controlled trial

To evaluate the efficacy and safety of Hedgehog Fungus Extract Granules in the treatment of chronic non-atrophic gastritis: A multi-center, randomized, double-blind, placebo-controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055788
Enrollment
Unknown
Registered
2022-01-19
Start date
2022-01-31
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Chronic non-atrophic gastritis

Interventions

Control group:Placebo
Experiment Group:Hedgehog Fungus Extract Granules

Sponsors

Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Fulfilling the Western Medicine diagnosis of chronic non-atrophic gastritis in Consensus on chronic gastritis in China (2017, Shanghai) of Chinese Society of Gastroenterology; 2. Have at least two symptoms in five major symptoms (epigastric pain, epigastric distension, heartburn, sour regurgitation and belching) and one or more symptom with score >= 2; 3. Aged between 18 to 65 years; 4. Willing to participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Have participated in other clinical trials within the past 1 month; 2. Those who have used Traditional Chinese medicine or patent Chinese medicine to improve the pathological condition of gastric mucosa in recent 2 weeks; 3. Patients who had used acid suppressors (H2 antagonists or proton pump inhibitors), stimulants (moxapride or domperidone, etc.) and gastric mucosal protective agents (tipreidone, sulfoaluminum, gifadione, glutamine, rebapete, bismuth, etc.) in the last 2 weeks; 4. Endoscopy revealed intraepithelial neoplasia and malignant transformation of gastric mucosa; Pathological diagnosis of atrophy, intestinal metaplasia; 5. Cholecystitis, gallstones or bile duct stones, biliary obstruction, chronic pancreatitis, chronic liver disease and other hepatobiliary diseases that can cause digestive tract symptoms; 6. People with mental illness or brain disease were judged to have significant anxiety or depression. 7. Patients with serious primary diseases of heart, liver, kidney, lung or blood system, with Cr of renal function and liver function (ALT, AST, TBIL) three times the upper limit of normal reference value; 8. Planning pregnancy, pregnancy or lactation; 9. Alcohol or drug abusers; 10. Allergic to drugs or ingredients used in this study; 11. Any other circumstances in which the Investigator considers the subject unable to participate in the study.

Design outcomes

Primary

MeasureTime frame
Total effective rate of 6 weeks after drug administration;

Secondary

MeasureTime frame
Total effective rate of 3 and 9 weeks after drug administration;Improvement rate of quality of life score (SF-36) at 3, 6 and 9 weeks after drug administration;The disappearance rate of symptoms at 3, 6 and 9 weeks after drug administration;Percentage change in total symptom score of 3, 6 and 9 weeks after drug administration;Percentage change in single symptom score of 3, 6 and 9 weeks after drug administration;marked effective rate of 3, 6 and 9 weeks after drug administration;

Countries

China

Contacts

Public ContactZhou Duowu

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

zdw_pi@126.com+86 13901617608

Outcome results

None listed

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