Sponsor study identifier
interventional
480
1 country
1
Study Start
March 1, 2019
Actual (reported)Primary Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 11, 2018
Actual (reported)January 30, 2019
Actual (reported)March 1, 2019
Actual (reported)December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
The score changes of Endoscopic Findings
six months
Main symptom score
six months
The patient-reported outcome (PRO)scale integrals
six months
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.
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.
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
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Folic Acid Tablet
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Folic Acid Tablet
Named ingredient: Folic acid
View registry recordXiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, 100091, China
First Submitted
July 11, 2018
First Posted
January 30, 2019
Study Start
March 1, 2019
Actual (reported)Primary Completion
December 31, 2021
Estimated (date passed)Safety and Efficacy of Folic Acid Combined With Atezolizumab and Bevacizumab as First-Line Therapy for Unresectable Hepatocellular Carcinoma
oral administration of folic acid tablets half an hour after meal for 5 mg each time for 3 times a day.
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 simulation tablets half a hour after meal for 5 mg each time for 3 times a day.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 25, 2021
Record last verified: 2021-06
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Source: ClinicalTrials.gov.
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