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Compound Granules of Hedyotis Diffusa for Chronic Atrophic Gastritis

Single-Arm Study of Compound Granules of Hedyotis Diffusa for Chronic Atrophic Gastritis

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07391800
Enrollment
20
Registered
2026-02-06
Start date
2026-01-31
Completion date
2027-07-31
Last updated
2026-02-06

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

Conditions

Chronic Atrophic Gastritis With Hyperplasia (Diagnosis)

Keywords

Compound Granules of Hedyotis diffusa, chronic atrophic gastritis

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.

Interventions

DRUGCompound Granules of Hedyotis diffusa

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

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.).

Design outcomes

Primary

MeasureTime frameDescription
Pathologic DiagnosisOne year after enrollmentImprovements 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.

Secondary

MeasureTime frameDescription
Endoscopic AssessmentOne year after enrollmentA senior endoscopist blinded to the patients' treatment group assignment scored the endoscopic findings in accordance with the Kyoto Classification of Gastritis (Appendix 3, Supplemental Digital Content 1, http://links.lww.com/JCG/A802).

Countries

China

Contacts

CONTACTShengying Gu
gsy15815@163.com+86-15921509854
PRINCIPAL_INVESTIGATORYun Liao

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026