NCT03823248

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 25, 2021

Status Verified

June 1, 2021

Enrollment Period

2.8 years

First QC Date

July 11, 2018

Last Update Submit

June 23, 2021

Conditions

Gastric Precancerous Condition

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    six months

Secondary Outcomes (3)

  • The score changes of Endoscopic Findings

    six months

  • Main symptom score

    six months

  • The patient-reported outcome (PRO)scale integrals

    six months

Study Arms (2)

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.

Drug: MoLuoDanDrug: Sanchi powderDrug: 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.

Drug: Folic Acid TabletDrug: MoLuoDan simulationDrug: Sanchi powder simulation

Interventions

MoLuoDanDRUG

oral administration of Moluodan concentrated pills with warm water before meal for 8 pills each time for three times a day

MoLuoDan and Sanchi powder group
Sanchi powderDRUG

oral administration of Sanchi powder mixing with warm water before meal for 3g each time for twice a day

MoLuoDan and Sanchi powder group
Folic Acid TabletDRUG

oral administration of folic acid tablets half an hour after meal for 5 mg each time for 3 times a day.

Folic Acid Tablet group
MoLuoDan simulationDRUG

oral administration of Moluodan simulation medicine with warm water before meal for 8 pills each time for three times a day

Folic Acid Tablet group
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 group
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.

MoLuoDan and Sanchi powder group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, 100091, China

RECRUITING

MeSH Terms

Interventions

moluodanFolic Acid

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Xiangxue Ma, Doctor

CONTACT

+86(010)62835641maxiangxue@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2018

First Posted

January 30, 2019

Study Start

March 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

June 25, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)