Atrophic Gastritis With Low-grade Intraepithelial NeoplasiaNCT06324825
Fuzheng Nizeng Formula for Chronic Atrophic Gastritis With Low-grade Intraepithelial Neoplasia, a Multicenter Randomized Controlled Trial
A study testing Fuzhegn Nizeng Decoction and Moluodan granules in people with Atrophic Gastritis With Low-grade Intraepithelial Neoplasia, run by Peking University First Hospital at 1 site in China.
Trial summary
Fuzheng Nizeng Formula (FZNZ) is derived from the classic formula Liujunzi Decoction. Former pilot study found that FZNZ promoted the recovery of gastric atrophy and relieve the relative symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrophic Gastritis With Low-grade Intraepithelial Neoplasia
- What is being tested?
- Fuzhegn Nizeng Decoction and Moluodan granules
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2022to 31 Dec 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Atrophic Gastritis With Low-grade Intraepithelial Neoplasia diagnosed by endoscopy and stomach biopsy.
- Helicobacter pylori negative.
- TCM syndrome is spleen-stomach deficiency with blood stasis and phelgm.
Who cannot join
- History of gastric surgery.
- Combined with malignant tumor.
- History of mental illness.
- Allergy to any components of the drug use in the study.
- Planning to pregnancy, or pregnant woman and lactating woman.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Xuezhi Zhang, Doctor, +861083572634, zhang.xuezhi@263.net
About this study
Official title: Fuzhegn Nizeng Formula for Chronic Atrophic Gastritis With Low-grade Intraepithelial Neoplasia, a Multicenter Randomized Controlled Trial
Fuzheng Nizeng Formula (FZNZ) is derived from the classic formula Liujunzi Decoction. Former pilot study found that FZNZ promoted the recovery of gastric atrophy and relieve the relative symptoms. This study is to evaluate its efficacy for chronic atrophic gastritis with low-grade intraepithelial neoplasia, compared with positive control Molduodan granule.
- Being tested
- Fuzhegn Nizeng Decoction, Moluodan granules
- Keywords
- Atrophic Gastritis, Intraepithelial Neoplasia
- Medical subject headings
- Gastritis, Atrophic, Carcinoma in Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fuzhegn Nizeng DecoctionDrug
Subjects taking prepared Fuzhegn Nizeng granules twice daily for 6 month.
Moluodan granulesDrug
Subjects taking prepared Moluodan granules 9g twice daily for 6 month.
| Study group | Role | What they receive |
|---|---|---|
| Fuzhegn Nizeng Formula | Experimental | Not described Receives: Drug: Fuzhegn Nizeng Decoction |
| Moluodan patient medicine | Active comparator | Not described Receives: Drug: Moluodan granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery rate of Low-grade Intraepithelial Neoplasia
Stomach biopsy will be taken after drug administration completion.
Measured: The 180 days after drug administration.
Secondary outcomes (2)
7-point Global Overall Symptom Scale
Dyspepsia symptoms will be recorded and evaluated by 7-point Global Overall Symptom Scale
Measured: 1st, 2nd, 3rd, 4th, 5th, 6th month
Adverse event rate
Any adverse event will be recorded.
Measured: The 6 months during the drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start24 Oct 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic Gastritis With Low-grade Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324825
- Sponsor's protocol ID
- 2022CR64
- Status last verified
- Mar 2024
- First submitted
- 1 Sep 2023
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fuzhegn Nizeng Formula for Chronic Atrophic Gastritis With Low-grade Intraepithelial Neoplasia, a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06324825
- Acronym / sponsor ID
- 2022CR64
- Keywords
- Atrophic Gastritis, Intraepithelial Neoplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Mar 2024 (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.
Fuzheng Nizeng Formula (FZNZ) is derived from the classic formula Liujunzi Decoction. Former pilot study found that FZNZ promoted the recovery of gastric atrophy and relieve the relative symptoms. This study is to evaluate its efficacy for chronic atrophic gastritis with low-grade intraepithelial neoplasia, compared with positive control Molduodan granule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fuzhegn Nizeng Formula | Experimental | Drug: Fuzhegn Nizeng Decoction |
| Moluodan patient medicine | Active comparator | Drug: Moluodan granules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic Atrophic Gastritis With Low-grade Intraepithelial Neoplasia diagnosed by endoscopy and stomach biopsy.
- Helicobacter pylori negative.
- TCM syndrome is spleen-stomach deficiency with blood stasis and phelgm.
Key exclusion criteria (5 listed)
- History of gastric surgery.
- Combined with malignant tumor.
- History of mental illness.
- Allergy to any components of the drug use in the study.
- Planning to pregnancy, or pregnant woman and lactating woman.
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 |
|---|---|---|
| Fuzhegn Nizeng DecoctionSubjects taking prepared Fuzhegn Nizeng granules twice daily for 6 month. | Drug | Fuzhegn Nizeng Formula |
| Moluodan granulesSubjects taking prepared Moluodan granules 9g twice daily for 6 month. | Drug | Moluodan patient medicine |
Primary outcome
Recovery rate of Low-grade Intraepithelial Neoplasia
Time frame: The 180 days after drug administration.
Stomach biopsy will be taken after drug administration completion.
2 secondary outcomes
7-point Global Overall Symptom Scale
Time frame: 1st, 2nd, 3rd, 4th, 5th, 6th month
Adverse event rate
Time frame: The 6 months during the drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: Undecided
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 study testing Fuzhegn Nizeng Decoction and Moluodan granules in people with Atrophic Gastritis With Low-grade Intraepithelial Neoplasia, run by Peking University First Hospital 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 5 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 22 Mar 2024. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery rate of Low-grade Intraepithelial Neoplasia (time frame: The 180 days after drug administration.). 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 22 Mar 2024.