Chronic Atrophic Gastritis With Hyperplasia (Diagnosis)NCT07391800
Compound Granules of Hedyotis Diffusa for Chronic Atrophic Gastritis
A study testing Compound Granules of Hedyotis diffusa in people with Chronic Atrophic Gastritis With Hyperplasia (Diagnosis), run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Chronic Atrophic Gastritis With Hyperplasia (Diagnosis)
- What is being tested?
- Compound Granules of Hedyotis diffusa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2026to 31 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai General Hospital
Shanghai, 200000
Qin Liacility Contact * Enter a facility contact for this location, 86-021-63240090, liqin0626@hotmail.com
About this study
Official title: Single-Arm Study of Compound Granules of Hedyotis Diffusa for Chronic Atrophic Gastritis
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.
Read more
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.
- Being tested
- Compound Granules of Hedyotis diffusa
- Keywords
- Compound Granules of Hedyotis diffusa, chronic atrophic gastritis
- Medical subject headings
- Disease, Gastritis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound Granules of Hedyotis diffusaDrug
12-month treatment with Compound Granules of Hedyotis diffusa and 12-month follow-up
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Compound Granules of Hedyotis diffusa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year after enrollment
Secondary outcomes (1)
Endoscopic Assessment
A 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).
Measured: One year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start31 Jan 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Atrophic Gastritis With Hyperplasia (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liao Yun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Yun Liao, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391800
- Sponsor's protocol ID
- LYun
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No