Atrophic GastritisPhase 2NCT05209633
Efficacy and Safety of Using Granules Dendrobii for the Treatment of Chronic Atrophic Gastritis
A Phase 2 study testing Granules Dendrobii in people with Atrophic Gastritis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Chronic atrophic gastritis (CAG) is a common and frequently-occurring disease, characterized by atrophy of gastric mucosal epithelium and glands, thinning of the mucosa, thickening of the submucosal muscle layer, intestinal metaplasia, and atypical hyperplasia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atrophic Gastritis
- What is being tested?
- Granules Dendrobii
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2022to 22 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfill the diagnosis of chronic atrophic gastritis;
- TCM syndrome differentiation is deficiency of both qi and yin;
- Aged between 18 and 65 years old, regardless of gender;
- Volunteer to participate in this clinical trial and sign an informed consent form.
Who cannot join
- Patients with peptic ulcer, acid reflux, etc. who need PPI treatment;
- Patients with high-grade intraepithelial neoplasia of gastric mucosa or suspected malignant transformation in pathological diagnosis;
- Those who have received anti-HP treatment and related treatments in the past two weeks;
- Diabetic patients;
- Patients with severe heart, liver, kidney, lung, blood system diseases, abnormal renal function Cr test with clinical significance, and liver function ALT ≥ 1.5 times the upper limit of the normal reference value;
- People with allergies or a history of allergies to multiple drugs (two or more or the known ingredients in the drug);
Show all 10Show fewer
- Those planning to become pregnant, pregnant or breast-feeding;
- Patients with mental illness;
- Those who have participated in other drug clinical trials within the past 3 months;
- The investigator believes that it is not suitable to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Using Granules Dendrobii for the Treatment of Chronic Atrophic Gastritis in Subjects With Deficiency of Qi and Yin: a Randomized, Double-blind, Parallel, Placebo-controlled Study
Chronic atrophic gastritis (CAG) is a common and frequently-occurring disease, characterized by atrophy of gastric mucosal epithelium and glands, thinning of the mucosa, thickening of the submucosal muscle layer, intestinal metaplasia, and atypical hyperplasia. The course of the disease is protracted and often recurrent, which seriously affects the work and physical and mental health of the patient. Moreover, epidemiological studies have shown that the risk of gastric cancer in patients with chronic multifocal atrophic gastritis is significantly higher than that of the general population. Because CAG intestinal metaplasia and dysplasia can easily develop into gastric cancer, the World Health Organization (WHO) listed CAG's gastric mucosal atrophy, intestinal metaplasia and dysplasia as precancerous lesions of gastric cancer in 1978. Therefore, reversing and disappearing the precancerous state of gastric cancer is an effective measure to prevent the occurrence of gastric cancer.
The cause of CAG is complicated. Modern medicine believes that CAG is closely related to biological factors, physical and chemical factors, immune factors, and genetic factors. At present, there is no specific treatment, but symptomatic treatment is the main treatment. The disease belongs to the categories of "stomach pain" and "suffocation" in traditional Chinese medicine.
Read more
In many years of surveys and studies in Mainland China, it is found that Dendrobii granules have a good effect on chronic atrophic gastritis. It is planned to explore the possibility, effectiveness and safety of Dendrobii granules in the treatment of chronic atrophic gastritis through clinical trials.
20 subjects will be randomized into the treatment group and placebo group with 18 weeks of treatment.
Read the detailed description
Chronic atrophic gastritis, (CAG) is a common and frequently-occurring disease, characterized by atrophy of gastric mucosal epithelium and glands, thinning of the mucosa, thickening of the submucosal muscle layer, intestinal metaplasia, and atypical hyperplasia. The course of the disease is protracted and often recurrent, which seriously affects the work and physical and mental health of the patient. Moreover, epidemiological studies have shown that the risk of gastric cancer in patients with chronic multifocal atrophic gastritis is significantly higher than that of the general population. Because CAG intestinal metaplasia and dysplasia can easily develop into gastric cancer, the World Health Organization (WHO) listed CAG's gastric mucosal atrophy, intestinal metaplasia and dysplasia as precancerous lesions of gastric cancer in 1978. Therefore, reversing and disappearing the precancerous state of gastric cancer is an effective measure to prevent the occurrence of gastric cancer. The study of CAG gastric mucosal atrophy and intestinal metaplasia reversal drugs not only has important academic significance, but also has good social and economic benefits, and has a broad market prospect.
The cause of CAG is complicated. Modern medicine believes that CAG is closely related to biological factors, physical and chemical factors, immune factors, and genetic factors. At present, there is no specific treatment, but symptomatic treatment is the main treatment. The disease belongs to the categories of "stomach pain" and "suffocation" in traditional Chinese medicine. The Chinese Medicine practitioners in the past have advocated that the main treatment is to nourish the stomach.
For more than two thousand years, a better understanding of Dendrobii used for "thick intestines and stomach", "calm the stomach", "replenish five internal organs and fatigue", and "light body and prolong life". There are many varieties of Dendrobii, especially Dendrobii officinale is the top grade. Dendrobii candidum is combined with American ginseng to nourish qi and nourish yin, nourish the stomach and promote fluid, nourish but not greasy, clear but not hurt the stomach.
This study used the Granules Dendrobii produced by Zhejiang Tianhuang Medical Plant Pharmaceutical Co., Ltd. (Hong Kong proprietary Chinese medicine registration number: HKC-16115). Granules Dendrobii has completed many pharmacodynamic and toxicological studies. In the many years of market investigation and research in Mainland China, it is found that Granules Dendrobii (Hong Kong Chinese Patent Medicine Registration Number: HKC-16115) has a good effect on chronic atrophic gastritis. Granules Dendrobii is suitable for the long-term conditioning and rehabilitation of spleen and stomach diseases that are weakened by spleen and stomach, or due to deficiency and solidification, resulting in spleen and stomach diseases mixed with deficiency and solid. Granules] with Dendrobium candidum as the main ingredient in the treatment of chronic atrophic gastritis has the traditional theoretical basis of Chinese medicine. Now plan to explore the possibility, effectiveness and safety of Granules Dendrobii in the treatment of chronic atrophic gastritis (qi and yin deficiency) through clinical trials.
- Conditions
- Atrophic Gastritis
- Being tested
- Granules Dendrobii, Placebo
- Medical subject headings
- Gastritis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granules DendrobiiDrug
Also called Dendrobii
6g each, 3 times per day, total 18 weeks
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Active treatment (Granules Dendrobii) | Experimental | 6g each, 3 times per day, total 18 weeks Receives: Drug: Granules Dendrobii |
| Placebo | Placebo comparator | 6g each, 3 times per day, total 18 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of histopathological grading of gastric mucosal atrophy.
Measure the improvement rate of histopathological grading of gastric mucosal atrophy.
Measured: 18 weeks
Secondary outcomes (7)
Histopathological changes of gastric mucosa
Other histopathological changes of gastric mucosa (intestinal metaplasia, dysplasia, chronic inflammatory reaction, activity, HP infection) grade changes by using the Visual Analogue Scale of New Sydney System. Mild, moderate and severe will be the grading of severity.
Measured: 18 weeks
Grading changes of gastric mucosa
Changes in the grading of the gastric mucosa of gastric antrum (including gastric angle) and gastric body (atrophy, intestinal metaplasia, dysplasia, chronic inflammatory reaction, activity, HP infection) by using the Visual Analogue Scale of New Sydney System. Mild, moderate and severe will be the grading of severity.
Measured: 18 weeks
Grading changes of epigastric bloating
The severity of epigastric bloating will be measured by using the scores 0,2,4,6. Which 0 means no symptom and 6 means most severe.
Three gradings will be recorded: Symptom disappeared, improving or unchanged. Symptom disappeared means the score return to 0. Improving means the score decreases from baseline. Unchanged means score remain the same with baseline.
Measured: 18 weeks
Grading changes of epigastric pain
The severity of epigastric pain will be measured by using the scores 0,2,4,6. Which 0 means no symptom and 6 means most severe.
Three gradings will be recorded: Symptom disappeared, improving or unchanged. Symptom disappeared means the score return to 0. Improving means the score decreases from baseline. Unchanged means score remain the same with baseline.
Measured: 18 weeks
The efficacy of TCM syndromes
Traditional Chinese Medicine syndromes such as epigastric bloating, epigastric pain, belching, loss of appetite will be assessed by the Chinese Medicine Practitioner. 4 gradings 0,1,2,3 will be used, which 3 is the most severe.
Measured: 18 weeks
Inflammation changes under OGD
The severity of inflammation of gastric mucosa will be assessed under endoscopy. Four gradings of the severity which are normal, mild, moderate and severe according to the Visual Analogue Scale of New Sydney System.
Measured: 18 weeks
The H. Pylori eradication rate
The H. Pylori eradication rate (positive at baseline)
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Nov 2022
- Primary completion22 Nov 2024
- Study completion22 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic GastritisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Lin Zhixiu, Chinese University of Hong Kong
- Investigators
- Zhixiu Lin, Professor, Principal investigator, Hong Kong Institute of Integrative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209633
- Sponsor's protocol ID
- Atrophic Gastritis Study
- Status last verified
- Jul 2026
- First submitted
- 1 Dec 2021
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Using Granules Dendrobii for the Treatment of Chronic Atrophic Gastritis in Subjects With Deficiency of Qi and Yin: a Randomized, Double-blind, Parallel, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05209633
- Acronym / sponsor ID
- Atrophic Gastritis Study
- Conditions
- Atrophic Gastritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic atrophic gastritis (CAG) is a common and frequently-occurring disease, characterized by atrophy of gastric mucosal epithelium and glands, thinning of the mucosa, thickening of the submucosal muscle layer, intestinal metaplasia, and atypical hyperplasia. The course of the disease is protracted and often recurrent, which seriously affects the work and physical and mental health of the patient. Moreover, epidemiological studies have shown that the risk of gastric cancer in patients with chronic multifocal atrophic gastritis is significantly higher than that of the general population. Because CAG intestinal metaplasia and dysplasia can easily develop into gastric cancer, the World Health Organization (WHO) listed CAG's gastric mucosal atrophy, intestinal metaplasia and dysplasia as precancerous lesions of gastric cancer in 1978. Therefore, reversing and disappearing the precancerous state of gastric cancer is an effective measure to prevent the occurrence of gastric cancer.
The cause of CAG is complicated. Modern medicine believes that CAG is closely related to biological factors, physical and chemical factors, immune factors, and genetic factors. At present, there is no specific treatment, but symptomatic treatment is the main treatment. The disease belongs to the categories of "stomach pain" and "suffocation" in traditional Chinese medicine.
In many years of surveys and studies in Mainland China, it is found that Dendrobii granules have a good effect on chronic atrophic gastritis. It is planned to explore the possibility, effectiveness and safety of Dendrobii granules in the treatment of chronic atrophic gastritis through clinical trials.
20 subjects will be randomized into the treatment group and placebo group with 18 weeks of treatment.
Detailed description
Chronic atrophic gastritis, (CAG) is a common and frequently-occurring disease, characterized by atrophy of gastric mucosal epithelium and glands, thinning of the mucosa, thickening of the submucosal muscle layer, intestinal metaplasia, and atypical hyperplasia. The course of the disease is protracted and often recurrent, which seriously affects the work and physical and mental health of the patient. Moreover, epidemiological studies have shown that the risk of gastric cancer in patients with chronic multifocal atrophic gastritis is significantly higher than that of the general population. Because CAG intestinal metaplasia and dysplasia can easily develop into gastric cancer, the World Health Organization (WHO) listed CAG's gastric mucosal atrophy, intestinal metaplasia and dysplasia as precancerous lesions of gastric cancer in 1978. Therefore, reversing and disappearing the precancerous state of gastric cancer is an effective measure to prevent the occurrence of gastric cancer. The study of CAG gastric mucosal atrophy and intestinal metaplasia reversal drugs not only has important academic significance, but also has good social and economic benefits, and has a broad market prospect.
The cause of CAG is complicated. Modern medicine believes that CAG is closely related to biological factors, physical and chemical factors, immune factors, and genetic factors. At present, there is no specific treatment, but symptomatic treatment is the main treatment. The disease belongs to the categories of "stomach pain" and "suffocation" in traditional Chinese medicine. The Chinese Medicine practitioners in the past have advocated that the main treatment is to nourish the stomach.
For more than two thousand years, a better understanding of Dendrobii used for "thick intestines and stomach", "calm the stomach", "replenish five internal organs and fatigue", and "light body and prolong life". There are many varieties of Dendrobii, especially Dendrobii officinale is the top grade. Dendrobii candidum is combined with American ginseng to nourish qi and nourish yin, nourish the stomach and promote fluid, nourish but not greasy, clear but not hurt the stomach.
This study used the Granules Dendrobii produced by Zhejiang Tianhuang Medical Plant Pharmaceutical Co., Ltd. (Hong Kong proprietary Chinese medicine registration number: HKC-16115). Granules Dendrobii has completed many pharmacodynamic and toxicological studies. In the many years of market investigation and research in Mainland China, it is found that Granules Dendrobii (Hong Kong Chinese Patent Medicine Registration Number: HKC-16115) has a good effect on chronic atrophic gastritis. Granules Dendrobii is suitable for the long-term conditioning and rehabilitation of spleen and stomach diseases that are weakened by spleen and stomach, or due to deficiency and solidification, resulting in spleen and stomach diseases mixed with deficiency and solid. Granules] with Dendrobium candidum as the main ingredient in the treatment of chronic atrophic gastritis has the traditional theoretical basis of Chinese medicine. Now plan to explore the possibility, effectiveness and safety of Granules Dendrobii in the treatment of chronic atrophic gastritis (qi and yin deficiency) through clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment (Granules Dendrobii) | Experimental | Drug: Granules Dendrobii6g each, 3 times per day, total 18 weeks |
| Placebo | Placebo comparator | Drug: Placebo6g each, 3 times per day, total 18 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fulfill the diagnosis of chronic atrophic gastritis;
- TCM syndrome differentiation is deficiency of both qi and yin;
- Aged between 18 and 65 years old, regardless of gender;
- Volunteer to participate in this clinical trial and sign an informed consent form.
Key exclusion criteria (10 listed)
- Patients with peptic ulcer, acid reflux, etc. who need PPI treatment;
- Patients with high-grade intraepithelial neoplasia of gastric mucosa or suspected malignant transformation in pathological diagnosis;
- Those who have received anti-HP treatment and related treatments in the past two weeks;
- Diabetic patients;
- Patients with severe heart, liver, kidney, lung, blood system diseases, abnormal renal function Cr test with clinical significance, and liver function ALT ≥ 1.5 times the upper limit of the normal reference value;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Granules DendrobiiAlso: Dendrobii6g each, 3 times per day, total 18 weeks | Drug | Active treatment (Granules Dendrobii) |
| Placeboplacebo | Drug | Placebo |
Primary outcome
Change of histopathological grading of gastric mucosal atrophy.
Time frame: 18 weeks
Measure the improvement rate of histopathological grading of gastric mucosal atrophy.
7 secondary outcomes
Histopathological changes of gastric mucosa
Time frame: 18 weeks
Grading changes of gastric mucosa
Time frame: 18 weeks
Grading changes of epigastric bloating
Time frame: 18 weeks
Grading changes of epigastric pain
Time frame: 18 weeks
The efficacy of TCM syndromes
Time frame: 18 weeks
Inflammation changes under OGD
Time frame: 18 weeks
The H. Pylori eradication rate
Time frame: 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Atrophic Gastritis
RecruitingObservational study
Helicobacter Pylori, Atrophic Gastritis and Intestinal Metaplasia Registry and Prospective Study
Helicobacter Pylori, Atrophic Gastritis
RecruitingObservational study
Prediction of Gastric Cancer in Intestinal Metaplasia and Atrophic Gastritis
Gastric Cancer, Intestinal Metaplasia
Active, not recruitingPhase 2
Curcumin in Preventing Gastric Cancer in Patients With Chronic Atrophic Gastritis or Gastric Intestinal Metaplasia
Chronic Atrophic Gastritis, Gastric Carcinoma
Enrolling by invitationObservational study
UC Davis Cohort of Pre-Malignant and Malignant Gastro-Intestinal DisEases Study
Intestinal Metaplasia, Chronic Gastritis
RecruitingObservational study
The Prevalence and the Pathophysiological Role of Non-Helicobacter Pylori Helicobacter Spp. in Well-defined Gastric Diseases and (Pre-) Malignancies
Functional Dyspepsia, Gastritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhixiu Lin, Professor principal investigator
Hong Kong Institute of Integrative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Granules Dendrobii in people with Atrophic Gastritis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of histopathological grading of gastric mucosal atrophy. (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.