Efficacy and Safety of Jianpi Qinghua Granules in Patients With Nonerosive Reflux Disease

NCT ID: NCT04324138

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-15
• Study Completion Date: 2021-12-31

Brief Summary

Nonerosive reflux disease (NERD) is a common refractory gastrointestinal disease. Proton pump inhibitors (PPIs), the first choice drug, have the following problems in clinical use: about 50 % of patients have no response to PPIs; the efficacy of simple acid suppression is poor; long-term use of PPIs can lead to indigestion, gastric polyps, atrophic gastritis, intestinal dysbacteriosis. Spleen Deficiency and Damp-heat Syndrome is one of the common clinical syndrome of NERD.TCM syndrome differentiation and treatment has the advantages of overall regulation and individualized treatment, but lack of high-level evidence. The purpose of this study is to evaluate the efficacy and safety of Jianpi Qinghua Granules for treating NERD with spleen deficiency and damp heat syndrome.

Detailed Description

Nonerosive reflux disease (NERD), representing about 70% of gastroesophageal reflux disease, is a common refractory gastrointestinal disease. Proton pump inhibitors (PPIs), the first choice drug, have the following problems in clinical use: about 50 % of patients have no response to PPIs; the efficacy of simple acid suppression is poor; long-term use of PPIs can lead to indigestion, gastric polyps, atrophic gastritis, intestinal dysbacteriosis. Spleen Deficiency and Damp-heat Syndrome is one of the common clinical syndrome of NERD.TCM syndrome differentiation and treatment has the advantages of overall regulation and individualized treatment, but lack of high-level evidence. NERD is the result of multifactorial pathogenicity. The reflux symptoms not only related to acid reflux, but also related to alkali, gas, mixed reflux, etc. The theory of Tongjiang put forward by Academician Dong Jianhua.Under the guidance of Academician Dong Jianhua, the research team create a prescription Jianpi Qinghua granule for treating NERD with spleen deficiency and damp-heat syndrome. The purpose of this study is to evaluate the efficacy and safety of Jianpi Qinghua Granules for treating NERD with spleen deficiency and damp heat syndrome based on a a multicenter,randomized, double-blind, placebo-controlled clinical trial.

On the basis of previous work, the project plans to establish sub centers in 3 Chinese hospitals, including78 patients with NERD and spleen deficiency and damp-heat syndrome. The therapeutic effects were evaluated from the following aspects: the VAS score of reflow and heartburn, the rate of discontinuation of antacids, the rate of recurrence of NERD symptoms, the score of TCM syndromes and the improvement of gastrointestinal function.

Conditions

Nonerosive Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental group

Jianpi Qinghua granules, 3 times a day and 1 hour after a meal

Group Type: EXPERIMENTAL

Jianpi Qinghua granules

Intervention Type: DRUG

3 times a day and 1 hour after a meal, for 4 weeks

Control group

Jianpi Qinghua placebo granules(inclued 5% of experimental drug),3 times a day and 1 hour after a meal

Group Type: SHAM_COMPARATOR

Jianpi Qinghua placebo granules

Intervention Type: DRUG

3 times a day and 1 hour after a meal, for 4 weeks

Interventions

Jianpi Qinghua granules

3 times a day and 1 hour after a meal, for 4 weeks

Intervention Type: DRUG

Jianpi Qinghua placebo granules

3 times a day and 1 hour after a meal, for 4 weeks

Intervention Type: DRUG

Other Intervention Names

experimental drugs; placebo

Eligibility Criteria

Inclusion Criteria

1. Subjects diagnosed with non-erosive reflux disease

2. Subjects who have a medical history of PPI with poor therapeutic effect

3. Subjects aged between 18 and 70 years

4. Subjects diagnosed with spleen deficiency damp-heat syndrome of traditional Chinese medicine

5. Subjects who voluntarily signed written informed consent form

Exclusion Criteria

1. Subjects who have active peptic ulcer, gastrointestinal hemorrhage, severe dysplasia of gastric mucosa or suspected malignant change, achalasia or postoperative achalasia

2. Subjects who have organic diseases of the digestive system (such as acute and chronic pancreatitis, cirrhosis, etc.), or systemic diseases that affect the gastrointestinal motility, such as hyperthyroidism, diabetes mellitus over 10 years, chronic renal insufficiency, spirit (the score of SAS and SDS shows severe anxiety or depression), nervous system diseases, etc

3. Subjects who have severe organ diseases such as heart, liver and kidney (such as ALT, AST more than 2 times of normal value), hematopoietic system diseases and tumors

4. Pregnant or lactating women

5. Subjects who have a history of nervous system disease and mental disease

6. Subjects who have a history of allergies to all the test drugs

7. Subjects who are participating in other clinical trials or have participated in other clinical trials within 4 weeks

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liaoning University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Xiyuan Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

beihua zhang, M.D

Role: STUDY_CHAIR

Xiyuan Hospital of China Academy of Chinese Medical Sciences

guang bai, M.D

Role: STUDY_DIRECTOR

Liaoning University of Traditional Chinese Medicine

wei wang, M.M

Role: STUDY_DIRECTOR

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Locations

Xiyuan Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

beihua zhang, M.D

Role: CONTACT

zhangbeihua888@163.com

+86(010)62835248

Facility Contacts

Beihua Zhang, doctorate

Role: primary

References

Zhang T, Bai G, Wang W, Liu L, Zhou Z, Ji H, Zhang B, Tang X. Efficacy and safety of Jianpi Qinghua granules for non-erosive reflux disease with spleen deficiency and damp-heat syndrome: a multicenter, randomized, double-blind, placebo-controlled clinical trial. Front Nutr. 2025 Jan 7;11:1509931. doi: 10.3389/fnut.2024.1509931. eCollection 2024.

Reference Type: DERIVED

PMID: 39839278 (View on PubMed)

Other Identifiers

2019YFC1709602-

Identifier Type: -

Identifier Source: org_study_id