Compound Granules of Hedyotis Diffusa for Chronic Atrophic Gastritis

NCT07391800 | Not Yet Recruiting

• 1 other identifier: LYun
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic atrophic gastritis is considered a premalignant lesion of gastric cancer. The development of gastric cancer usually follows the Correa sequence: chronic superficial gastritis → chronic atrophic gastritis → intestinal metaplasia → dysplasia → gastric cancer. Premalignant lesions of gastric cancer, such as superficial gastritis with intestinal metaplasia, atrophic gastritis with intestinal metaplasia, and atypical hyperplasia, have a high risk of progressing to gastric cancer if not intervened in a timely and effective manner. Currently, Western medicine treatment for chronic atrophic gastritis mainly includes eradicating Helicobacter pylori, supplementing folic acid or vitamins, and using gastric mucosal protectants. However, there is no specific drug to reverse gastric mucosal atrophy, and clinical needs are far from being met. According to traditional Chinese medicine (TCM) theory, chronic atrophic gastritis falls into the categories of "epigastric pain" and "gastric discomfort". It is treated based on syndrome differentiation, including various syndrome types such as spleen-stomach deficiency, qi stagnation and blood stasis, and damp-heat accumulation. TCM compound preparations have shown unique advantages in the treatment of chronic atrophic gastritis due to their advantages of multi-target and overall regulation. Chinese patent medicines such as Moluo Dan and Weifuchun Capsules have effects such as clearing heat and detoxifying, anti-inflammation, anti-bacteria, and treating chronic gastritis. Their clinical application provides important references for TCM intervention in chronic atrophic gastritis. However, there are still problems such as large individual differences in efficacy and poor response in some patients. Moreover, the precise treatment strategies for different TCM syndrome types (such as spleen-stomach deficiency type and liver-stomach disharmony type) need to be optimized. Compound Granules of Hedyotis diffusa, composed of three TCM herbs: Hedyotis diffusa, Smilax china L., and Solanum lyratum Thunb., is a classic ancient prescription that has been used in Shanghai First People's Hospital for many years. It is a hospital preparation approved for production by the Shanghai Food and Drug Administration (Approval No.: SYZ-ZF-003-2007), with the effects of clearing heat and detoxifying, and resolving blood stasis and dissipating masses. It is used for superficial gastritis, atrophic gastritis with intestinal metaplasia, atypical hyperplasia, etc., and has a preventive and therapeutic effect on premalignant lesions of gastric cancer and gastric cancer. Long-term clinical observations have found that it can not only relieve symptoms but also may have a certain improvement effect on the pathological changes of gastric mucosa. Literature reports indicate that traditional Chinese medicines represented by Hedyotis diffusa, Smilax china L., and Solanum lyratum Thunb. have good anti-inflammatory and anti-tumor activities. Due to differences between Chinese and Western cultures and the complex composition of TCM, TCM and TCM compound preparations have not yet been universally recognized by the international community. Therefore, studying TCM compound preparations using modern scientific methods, clarifying their effects as much as possible, and endowing traditional medicine with modern scientific connotations hold great clinical and social significance. Long-term clinical practice observations in Shanghai First People's Hospital have found that Compound Granules of Hedyotis diffusa has a certain preventive and therapeutic effect on atrophic gastritis with intestinal metaplasia and premalignant lesions of gastric cancer. However, there is currently a lack of systematic clinical research data support. Therefore, this clinical study will comprehensively evaluate the efficacy and safety of Compound Granules of Hedyotis diffusa in the treatment of atrophic gastritis, so as to provide a basis for its clinical application.

Conditions

Chronic Atrophic Gastritis With Hyperplasia (Diagnosis)

Keywords

Compound Granules of Hedyotis diffusa; chronic atrophic gastritis

Outcome Measures

Primary Outcomes (1)

• Pathologic Diagnosis

  Improvements in histologic scores and effective rates were calculated in patients who had undergone biopsy at least 2 times at the same site before and after treatment. Improved efficacy of histology was rated as effective or ineffective. Effective was defined as atrophy or intestinal metaplasia (IM) decreased at least one grade. Ineffective was defined as no improvement or the condition becoming worse.

  One year after enrollment

Secondary Outcomes (1)

• Endoscopic Assessment

  One year after enrollment

Other Outcomes (3)

• Symptom

  A follow-up visit was conducted at baseline and at 4, 13, 26, 39, and 52 weeks following drug administration.

• Adverse Event Incidence Rate

  A follow-up visit was conducted at 4, 13, 26, 39, and 52 weeks following drug administration.

• Serum Gastric Function Parameters

  A follow-up visit was conducted at baseline and at 4, 13, 26, 39, and 52 weeks following drug administration.

Study Arms (1)

Compound Granules of Hedyotis diffusa Group

EXPERIMENTAL

Patients received Compound Granules of Hedyotis diffusa for 12 months, followed by a 12-month follow-up period.

Drug: Compound Granules of Hedyotis diffusa

Interventions

Compound Granules of Hedyotis diffusa DRUG

12-month treatment with Compound Granules of Hedyotis diffusa and 12-month follow-up

Compound Granules of Hedyotis diffusa Group

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 35 and 80 years old;
• Diagnosed with atrophic gastritis with intestinal metaplasia by gastroscopic examination and histopathological diagnosis;
• TCM diagnosis of spleen-stomach damp-heat syndrome;
• Able to understand and sign the informed consent form, and willing to cooperate to complete the entire research process.

You may not qualify if:

• Previous history of gastric cancer or complicated with high-grade intraepithelial neoplasia;
• Lactation or pregnancy;
• Severe mental illness;
• Other severe systemic diseases (such as malignant tumors, severe heart, liver, or renal failure, etc.).

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, 200000, China

Location

MeSH Terms

Conditions

Disease; Gastritis, Atrophic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Yun Liao

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shengying Gu

CONTACT

+86-15921509854; gsy15815@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Pharmacist

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: February 6, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)