Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion

Therapeutic Mechanism of Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion:A Multi-center, Randomized and Controlled Experiment

Sponsors

Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences

Collaborator: 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
The Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine
Traditional Chinese Medicine Hospital of KUNSHAN
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

Source Xiyuan Hospital of China Academy of Chinese Medical Sciences
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.

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.

Overall Status Recruiting
Start Date 2019-03-01
Completion Date 2021-12-31
Primary Completion Date 2021-12-31
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
The disappearance rate of dysplasia six months
The score changes of histopathology six months
Secondary Outcome
Measure Time Frame
The score changes of Endoscopic Findings six months
Main symptom score six months
The patient-reported outcome (PRO)scale integrals six months
Enrollment 480
Condition
Intervention

Intervention Type: Drug

Intervention Name: MoLuoDan

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

Arm Group Label: MoLuoDan and Sanchi powder group

Intervention Type: Drug

Intervention Name: Sanchi powder

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

Arm Group Label: MoLuoDan and Sanchi powder group

Intervention Type: Drug

Intervention Name: Folic Acid Tablet

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

Arm Group Label: Folic Acid Tablet group

Intervention Type: Drug

Intervention Name: MoLuoDan simulation

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

Arm Group Label: Folic Acid Tablet group

Intervention Type: Drug

Intervention Name: Sanchi powder simulation

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

Arm Group Label: Folic Acid Tablet group

Intervention Type: Drug

Intervention Name: Folic Acid Tablet simulation

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

Arm Group Label: MoLuoDan and Sanchi powder group

Eligibility

Criteria:

Inclusion Criteria: 1. Outpatients and inpatients diagnosed with chronic atrophic gastritis accompanying with low grade intraepithelial neoplasia and indefinite dysphasia confirmed by gastroscopy and histopathological examination; 2. Patients aged from 18-75 years; 3. Subjects who were informed and voluntarily signed the informed consent. Exclusion Criteria: 1. Patients pathohistologically diagnosed with high grade intraepithelial neoplasia/severe dysplasia; 2. Patients with a history of gastric ulcer, gastric polyps and gastric surgery; 3. Patients taking NSAIDs for a long term; 4. Patients suspected of gastric cancer or malignant lesions in other systems; 5. Patients with a history of gastric surgery; 6. 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) 7. Patients with mental disease, dysgnosia and logopathy; 8. Pregnant women, or those preparing a pregnancy and breastfeeding women; 9. Patients with a allergic history of medicines used in this experiment.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

75 Years

Healthy Volunteers:

No

Overall Contact

Last Name: Xiangxue Ma, Doctor

Phone: +86(010)62835641

Email: [email protected]

Location
Facility: Status: Contact: Xiyuan Hospital of China Academy of Chinese Medical Sciences Xiangxue Ma [email protected]
Location Countries

China

Verification Date

2021-06-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: MoLuoDan and Sanchi powder group

Type: Experimental

Description: 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.

Label: Folic Acid Tablet group

Type: Active Comparator

Description: 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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

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