Jianpi Huoxue Recipe in Treating Gastric Premalignant Lesion

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.

Conditions

• Gastric Precancerous Condition

Interventions

DRUG

MoLuoDan

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

DRUG

Sanchi powder

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

DRUG

Folic Acid Tablet

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

DRUG

MoLuoDan simulation

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

DRUG

Sanchi powder simulation

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

DRUG

Folic Acid Tablet simulation

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

Sponsors & Collaborators

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Beijing Friendship Hospital

  collaborator OTHER

• Wuhan Integrated Traditional Chinese and Western Medicine Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

  collaborator UNKNOWN

• The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine

  collaborator OTHER

• The Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

  collaborator UNKNOWN

• Traditional Chinese Medicine Hospital of KUNSHAN

  collaborator UNKNOWN

• Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

  collaborator UNKNOWN

• Xiyuan Hospital of China Academy of Chinese Medical Sciences

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-01

Primary Completion

2021-12-31

Completion

2021-12-31

Countries

• China

Study Locations