Gastric Precancerous ConditionPhase 1/2NCT03823248
Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion
A Phase 1/2 study testing MoLuoDan, Sanchi powder and Folic Acid Tablet in people with Gastric Precancerous Condition, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
This study had adopted the multi-center, randomized and controlled experiment design based on standardized mucosal biopsy and pathohistological operation, as well as therapeutic evaluation methodology. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Precancerous Condition
- What is being tested?
- MoLuoDan, Sanchi powder and Folic Acid Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 31 Dec 2021
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients and inpatients diagnosed with chronic atrophic gastritis accompanying with low grade intraepithelial neoplasia and indefinite dysphasia confirmed by gastroscopy and histopathological examination;
- Patients aged from 18-75 years;
- Subjects who were informed and voluntarily signed the informed consent.
Who cannot join
- Patients pathohistologically diagnosed with high grade intraepithelial neoplasia/severe dysplasia;
- Patients with a history of gastric ulcer, gastric polyps and gastric surgery;
- Patients taking NSAIDs for a long term;
- Patients suspected of gastric cancer or malignant lesions in other systems;
- Patients with a history of gastric surgery;
- Patients with concurrent primary diseases in cardiovascular, cerebrovascular, liver, kidney and hemopoietic systems (ALT>80 u/L, and/or AST>80 u/L, with abnormal renal function)
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- Patients with mental disease, dysgnosia and logopathy;
- Pregnant women, or those preparing a pregnancy and breastfeeding women;
- Patients with a allergic history of medicines used in this experiment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, 100091
Xiangxue Ma, maxiangxue@163.com
About this study
Official title: Therapeutic Mechanism of Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion：A Multi-center, Randomized and Controlled Experiment
This study had adopted the multi-center, randomized and controlled experiment design based on standardized mucosal biopsy and pathohistological operation, as well as therapeutic evaluation methodology. Meanwhile, patients diagnosed with chronic atrophic gastritis accompanying with low grade intraepithelial neoplasia and indefinite dysphasia (grade C2/C3 of Vienna classification) confirmed by gastroscopic histopathology were enrolled as the objects of study, while folic acid was used as the control. The therapeutic effect and safety of Jianpi Huoxue Recipe (Moluodan + Sanchi powder) in intervening the gastric Premalignant lesion were evaluated from the points of view of pathology, gastroscopy and symptoms. The elimination rate of intraepithelial neoplasia of gastric mucosa was expected to be improved by 9-12%. Moreover, high quality evidence-based medical evidence regarding traditional Chinese medicine (TCM) in intervening gastric Premalignant lesion would be obtained, which could form the mature, propagable and effective scheme.
Read the detailed description
Intraepithelial neoplasia of gastric mucosa is a well-recognized gastric Premalignant lesion, which is the key of secondary prevention for gastric cancer. However, no universally acknowledged effective therapeutic scheme is available at present. Previously, the investigator's research group has carried out clinical trial study based on solving the key problems such as diagnostic criteria, mucosal biopsy consistency and therapeutic evaluation methodology, and has attained certain achievements. This study had adopted the multi-center, randomized and controlled experiment design based on standardized mucosal biopsy and pathohistological operation, as well as therapeutic evaluation methodology. Meanwhile, patients diagnosed with chronic atrophic gastritis accompanying with low grade intraepithelial neoplasia and indefinite dysphasia (grade C2/C3 of Vienna classification) confirmed by gastroscopic histopathology were enrolled as the objects of study, while folic acid was used as the control. The therapeutic effect and safety of Jianpi Huoxue Recipe (Moluodan + Sanchi powder) in intervening the gastric Premalignant lesion were evaluated from the points of view of pathology, gastroscopy and symptoms. The elimination rate of intraepithelial neoplasia of gastric mucosa was expected to be improved by 9-12%. Moreover, high quality evidence-based medical evidence regarding traditional Chinese medicine (TCM) in intervening gastric Premalignant lesion would be obtained, which could form the mature, propagable and effective scheme. At the same time, molecular and biological indicators, including CDX2, SOX2, MUC2, MUC6, MUC5AC and CD10, were detected using the pathological tissues, so as to explore the therapeutic mechanism of Jianpi Huoxue Recipe in intervening gastric Premalignant lesion, and to construct the model platform for special disease research on gastric Premalignant lesion.
- Conditions
- Gastric Precancerous Condition
- Being tested
- MoLuoDan, Sanchi powder, Folic Acid Tablet, MoLuoDan simulation, Sanchi powder simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoLuoDanDrug
oral administration of Moluodan concentrated pills with warm water before meal for 8 pills each time for three times a day
Sanchi powderDrug
oral administration of Sanchi powder mixing with warm water before meal for 3g each time for twice a day
Folic Acid TabletDrug
oral administration of folic acid tablets half an hour after meal for 5 mg each time for 3 times a day.
MoLuoDan simulationDrug
oral administration of Moluodan simulation medicine with warm water before meal for 8 pills each time for three times a day
Sanchi powder simulationDrug
oral administration of Sanchi powder simulation medicine mixing with warm water before meal for 3g each time for twice a day
Folic Acid Tablet simulationDrug
oral administration of folic acid simulation tablets half a hour after meal for 5 mg each time for 3 times a day.
| Study group | Role | What they receive |
|---|---|---|
| MoLuoDan and Sanchi powder group | Experimental | Experiment group: oral administration of Moluodan concentrated pills with warm water before meal for 8 pills each time for three times a day, + oral administration of Sanchi powder mixing with warm water before meal for 3g each time for twice a day, + oral administration of Folic Acid Tablet simulation half a hour after meal for 5 mg each time for 3 times a day. The medication period was 24 weeks. Receives: Drug: MoLuoDan; Drug: Sanchi powder; Drug: Folic Acid Tablet simulation |
| Folic Acid Tablet group | Active comparator | Control group: oral administration of Moluodan simulation medicine with warm water before meal for 8 pills each time for three times a day, + oral administration of Sanchi powder simulation medicine mixing with warm water before meal for 3g each time for twice a day, + oral administration of folic acid tablets half a hour after meal for 5 mg each time for 3 times a day. The medication period was 24 weeks. Receives: Drug: Folic Acid Tablet; Drug: MoLuoDan simulation; Drug: Sanchi powder simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The disappearance rate of dysplasia
The all patients' histopathology will be evaluated two times, the first time is when the patients' are included into the clinical trials, the second time is after 24 weeks treatment in each group, patients' histopathology should be evaluated for comparison between two groups,at the same time patients' histopathology should be evaluated for comparison in each group.The change in histological score (mean score of all biopsie after treatment in each group and between groups was calculated. The response rate of each pathological lesion was calculated as a percentage of those improved or disappeared at the 6th month to all subjects. The disappearance rate of dysplasia between groups were compared, which was defined as the absence of dysplasia (score 0) in all biopsy specimens after treatment.
Measured: six months
The score changes of histopathology
The score changes of atrophy, intestinal metaplasia, chronic inflammation and active inflammation compared between baseline and after 6-month treatment.
Measured: six months
Secondary outcomes (3)
The score changes of Endoscopic Findings
The score changes of endoscopic findings, such as erosion, bleeding, coarse and uneven mucosa, and bile reflux were compared between baseline and after 6-month treatment.
Measured: six months
Main symptom score
Changes of symptom score were compared. The symptom include upper abdominal pain, upper abdominal distension, poor appetite, nausea and belching. The disappearance rate of symptom was expressed as a percentage of the subjects whose symptoms disappeared after medication to those exhibiting symptoms before medication.
Measured: six months
The patient-reported outcome (PRO)scale integrals
The patient-reported outcome (PRO) instrument for chronic gastrointestinal diseases was a 35-item instrument, including 6 dimensions of regurgitation, dyspepsia, defecation, general condition, emotion and social function. All items graded into 5 levels and scored 0-4, except for decreased appetite, which is grouped into 4 levels and scored 0-3.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Mar 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Precancerous ConditionStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial Hospital of Traditional Chinese Medicine, Beijing Friendship Hospital, Wuhan Integrated Traditional Chinese and Western Medicine Hospital, The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Shaanxi Hospital of Traditional Chinese Medicine, Kunshan Hospital of Traditional Chinese Medicine, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823248
- Sponsor's protocol ID
- 2017YFC1700601
- Status last verified
- Jun 2021
- First submitted
- 11 Jul 2018
- Last updated
- 25 Jun 2021
- 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 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Mechanism of Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion：A Multi-center, Randomized and Controlled Experiment
- ClinicalTrials.gov ID
- NCT03823248
- Acronym / sponsor ID
- 2017YFC1700601
- Conditions
- Gastric Precancerous Condition
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Guangdong Provincial Hospital of Traditional Chinese Medicine, Beijing Friendship Hospital, Wuhan Integrated Traditional Chinese and Western Medicine Hospital, The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Shaanxi Hospital of Traditional Chinese Medicine, Kunshan Hospital of Traditional Chinese Medicine, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 30 Jan 2019 (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.
This study had adopted the multi-center, randomized and controlled experiment design based on standardized mucosal biopsy and pathohistological operation, as well as therapeutic evaluation methodology. Meanwhile, patients diagnosed with chronic atrophic gastritis accompanying with low grade intraepithelial neoplasia and indefinite dysphasia (grade C2/C3 of Vienna classification) confirmed by gastroscopic histopathology were enrolled as the objects of study, while folic acid was used as the control. The therapeutic effect and safety of Jianpi Huoxue Recipe (Moluodan + Sanchi powder) in intervening the gastric Premalignant lesion were evaluated from the points of view of pathology, gastroscopy and symptoms. The elimination rate of intraepithelial neoplasia of gastric mucosa was expected to be improved by 9-12%. Moreover, high quality evidence-based medical evidence regarding traditional Chinese medicine (TCM) in intervening gastric Premalignant lesion would be obtained, which could form the mature, propagable and effective scheme.
Detailed description
Intraepithelial neoplasia of gastric mucosa is a well-recognized gastric Premalignant lesion, which is the key of secondary prevention for gastric cancer. However, no universally acknowledged effective therapeutic scheme is available at present. Previously, the investigator's research group has carried out clinical trial study based on solving the key problems such as diagnostic criteria, mucosal biopsy consistency and therapeutic evaluation methodology, and has attained certain achievements. This study had adopted the multi-center, randomized and controlled experiment design based on standardized mucosal biopsy and pathohistological operation, as well as therapeutic evaluation methodology. Meanwhile, patients diagnosed with chronic atrophic gastritis accompanying with low grade intraepithelial neoplasia and indefinite dysphasia (grade C2/C3 of Vienna classification) confirmed by gastroscopic histopathology were enrolled as the objects of study, while folic acid was used as the control. The therapeutic effect and safety of Jianpi Huoxue Recipe (Moluodan + Sanchi powder) in intervening the gastric Premalignant lesion were evaluated from the points of view of pathology, gastroscopy and symptoms. The elimination rate of intraepithelial neoplasia of gastric mucosa was expected to be improved by 9-12%. Moreover, high quality evidence-based medical evidence regarding traditional Chinese medicine (TCM) in intervening gastric Premalignant lesion would be obtained, which could form the mature, propagable and effective scheme. At the same time, molecular and biological indicators, including CDX2, SOX2, MUC2, MUC6, MUC5AC and CD10, were detected using the pathological tissues, so as to explore the therapeutic mechanism of Jianpi Huoxue Recipe in intervening gastric Premalignant lesion, and to construct the model platform for special disease research on gastric Premalignant lesion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MoLuoDan and Sanchi powder group | Experimental | Drug: MoLuoDan, Drug: Sanchi powder, Drug: Folic Acid Tablet simulationExperiment group: oral administration of Moluodan concentrated pills with warm water before meal for 8 pills each time for three times a day, + oral administration of Sanchi powder mixing with warm water before meal for 3g each time for twice a day, + oral administration of Folic Acid Tablet simulation half a hour after meal for 5 mg each time for 3 times a day. The medication period was 24 weeks. |
| Folic Acid Tablet group | Active comparator | Drug: Folic Acid Tablet, Drug: MoLuoDan simulation, Drug: Sanchi powder simulationControl group: oral administration of Moluodan simulation medicine with warm water before meal for 8 pills each time for three times a day, + oral administration of Sanchi powder simulation medicine mixing with warm water before meal for 3g each time for twice a day, + oral administration of folic acid tablets half a hour after meal for 5 mg each time for 3 times a day. The medication period was 24 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Outpatients and inpatients diagnosed with chronic atrophic gastritis accompanying with low grade intraepithelial neoplasia and indefinite dysphasia confirmed by gastroscopy and histopathological examination;
- Patients aged from 18-75 years;
- Subjects who were informed and voluntarily signed the informed consent.
Key exclusion criteria (9 listed)
- Patients pathohistologically diagnosed with high grade intraepithelial neoplasia/severe dysplasia;
- Patients with a history of gastric ulcer, gastric polyps and gastric surgery;
- Patients taking NSAIDs for a long term;
- Patients suspected of gastric cancer or malignant lesions in other systems;
- Patients with a history of gastric surgery;
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 |
|---|---|---|
| MoLuoDanoral administration of Moluodan concentrated pills with warm water before meal for 8 pills each time for three times a day | Drug | MoLuoDan and Sanchi powder group |
| Sanchi powderoral administration of Sanchi powder mixing with warm water before meal for 3g each time for twice a day | Drug | MoLuoDan and Sanchi powder group |
| Folic Acid Tabletoral administration of folic acid tablets half an hour after meal for 5 mg each time for 3 times a day. | Drug | Folic Acid Tablet group |
| MoLuoDan simulationoral administration of Moluodan simulation medicine with warm water before meal for 8 pills each time for three times a day | Drug | Folic Acid Tablet group |
| Sanchi powder simulationoral administration of Sanchi powder simulation medicine mixing with warm water before meal for 3g each time for twice a day | Drug | Folic Acid Tablet group |
| Folic Acid Tablet simulationoral administration of folic acid simulation tablets half a hour after meal for 5 mg each time for 3 times a day. | Drug | MoLuoDan and Sanchi powder group |
Primary outcome
The disappearance rate of dysplasia
Time frame: six months
The all patients' histopathology will be evaluated two times, the first time is when the patients' are included into the clinical trials, the second time is after 24 weeks treatment in each group, patients' histopathology should be evaluated for comparison between two groups,at the same time patients' histopathology should be evaluated for comparison in each group.The change in histological score (mean score of all biopsie after treatment in each group and between groups was calculated. The response rate of each pathological lesion was calculated as a percentage of those improved or disappeared at the 6th month to all subjects. The disappearance rate of dysplasia between groups were compared, which was defined as the absence of dysplasia (score 0) in all biopsy specimens after treatment.
The score changes of histopathology
Time frame: six months
The score changes of atrophy, intestinal metaplasia, chronic inflammation and active inflammation compared between baseline and after 6-month treatment.
3 secondary outcomes
The score changes of Endoscopic Findings
Time frame: six months
Main symptom score
Time frame: six months
The patient-reported outcome (PRO)scale integrals
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MoLuoDan, Sanchi powder and Folic Acid Tablet in people with Gastric Precancerous Condition, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 25 Jun 2021. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangxue Ma, Doctor (+86(010)62835641, maxiangxue@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The disappearance rate of dysplasia (time frame: six months). The study lists 2 primary outcomes in all. 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 25 Jun 2021.