Compound Granules of Hedyotis Diffusa for Chronic Atrophic Gastritis
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.
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shengying Gu
- Phone Number: +86-15921509854
- Email: gsy15815@163.com
Study Locations
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Shanghai, China, 200000
- Shanghai General Hospital
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Contact:
- Qin Liacility Contact * Enter a facility contact for this location
- Phone Number: 86-021-63240090
- Email: liqin0626@hotmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Compound Granules of Hedyotis diffusa Group
Patients received Compound Granules of Hedyotis diffusa for 12 months, followed by a 12-month follow-up period.
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12-month treatment with Compound Granules of Hedyotis diffusa and 12-month follow-up
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pathologic Diagnosis
Time Frame: One year after enrollment
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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.
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One year after enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Endoscopic Assessment
Time Frame: One year after enrollment
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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).
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One year after enrollment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Symptom
Time Frame: A follow-up visit was conducted at baseline and at 4, 13, 26, 39, and 52 weeks following drug administration.
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Symptom improvement efficacy was categorized into three grades: markedly effective (complete or near-complete resolution of clinical symptoms including epigastric pain, abdominal distension, anorexia, belching, and acid regurgitation); effective (significant symptom relief or >50% reduction in symptom scores); and ineffective (<50% reduction in symptom scores or symptom exacerbation).
Total effective rate was calculated as the percentage of the sum of markedly effective and effective cases relative to the total cases.
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A follow-up visit was conducted at baseline and at 4, 13, 26, 39, and 52 weeks following drug administration.
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Adverse Event Incidence Rate
Time Frame: A follow-up visit was conducted at 4, 13, 26, 39, and 52 weeks following drug administration.
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An independent investigator interviewed patients quarterly to record adherence and queried about adverse events.
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A follow-up visit was conducted at 4, 13, 26, 39, and 52 weeks following drug administration.
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Serum Gastric Function Parameters
Time Frame: A follow-up visit was conducted at baseline and at 4, 13, 26, 39, and 52 weeks following drug administration.
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Serum gastric function indicators were tested every three months via blood sampling, with the detection of Pepsinogen 1 (PGⅠ) and Pepsinogen 2 (PGⅡ).
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A follow-up visit was conducted at baseline and at 4, 13, 26, 39, and 52 weeks following drug administration.
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Collaborators and Investigators
Investigators
- Principal Investigator: Yun Liao, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LYun
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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