Tongjiang Series Prescription Combined With PPIs Descending Ladder Withdrawal in Treating Nonerosive Reflux Disease

Summary

Nonerosive Reflux Disease (NERD) is a common refractory gastrointestinal disease. Proton Pump Inhibitors (PPIs), the preferred drug, have poor response, single target and poor acid inhibition effect in some patients in clinical application. Long-term use of PPI can lead to many side effects, even dependency. The main Traditional Chinese Medicine (TCM)syndrome types of NERD are liver-stomach depression-heat syndrome, spleen deficiency damp-heat syndrome and cold-heat complicated syndrome. TCM syndrome differentiation treatment has the advantages of overall regulation and individualized treatment. The purpose of this study is to evaluate the safety and efficacy advantages of syndrome differentiation series prescription combined with PPIs descending ladder withdrawal in the treatment of patients who use PPIs for a long time that can not stop, and to solve the problems of multiple side effects and dependency caused by long-term use of PPIs.

Conditions

• Nonerosive Reflux Disease

Interventions

DRUG

Tongjiang series prescription(Tongjiang granules, Jianpi Qinghua granules and Wenpi Qingwei granules)

According to the syndrome differentiation of TCM, Tongjiang granules are taken orally by patients with liver-stomach depression-heat syndrome, Jianpi Qinghua granules are taken orally by patients with spleen deficiency damp-heat syndrome, Wenpi Qingwei granules are taken orally by patients with cold-heat complicated syndrome, 1 bag per time, 3 times a day and 1 hour after a meal.

DRUG

Acid inhibitors

In the 1-2 weeks, acid inhibitor (PPI) was reduced from the dose before entering the group to half of the dose, once a day, before going to bed; in the 3-4 weeks, acid inhibitor was changed from PPI to famotidine tablets, 20mg each time, before going to bed; in the 5-6 weeks, all acid inhibitors were stopped.

DRUG

Placebo

Tongjiang granules placebo , Jianpi Qinghua granules placebo and Wenpi Qingwei granules placebo. The above three kinds of granulated placebo are respectively made of the simulation containing the low dose original prescription. Taking method is the same as Tongjiang series prescription.

Sponsors & Collaborators

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Wuhan No.1 Hospital

  collaborator OTHER

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

  collaborator OTHER

• Traditional Chinese Medicine Hospital of KUNSHAN

  collaborator UNKNOWN

• Liuzhou Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Xiyuan Hospital of China Academy of Chinese Medical Sciences

  lead OTHER

Principal Investigators

• Xudong Tang, M.D. · China Academy of Chinese Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-15

Primary Completion

2021-12-01

Completion

2021-12-31

Countries

• China

Study Locations