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

NCT04324138 | Unknown Early Phase 1 DMC

• 1 other identifier: 2019YFC1709602-
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonerosive Reflux Disease

Keywords

Nonerosive Reflux Disease; Traditional Chinese Medicine; Randomized placebo controlled trial

Outcome Measures

Primary Outcomes (1)

• Change of visual analogue (VAS) score of reflux symptoms and heartburn

  During the treatment, the patients recorded the reflux and heartburn attacks (attack times and duration) within 24 hours every day on the symptom diary card, and VAS scores were performed on the reflux and heartburn symptoms. The average score of each symptom in the past week was calculated. The decrease rate of symptom score≥50% from baseline was recorded as response after 1 week of treatment , and the number of response weeks was more than 50% of the whole treatment period, which was considered effective.

  week 1, week 2，week 3, week 4 during treatment period, week 6 and week 8 during follow-up period

Secondary Outcomes (6)

• Change of secondary symptom score

  week 2, week 4 during treatment period, week 6 and week 8 during follow-up period

• Change of traditional Chinese Medicine syndrome score

  week 2, week 4 during treatment period, week 6 and week 8 during follow-up period

• Change of gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) scale score

  week 2, week 4 during treatment period, week 6 and week 8 during follow-up period

• Change of patient ported outcome (PRO) for chronic gastrointestinal disease scale score

  week 2, week 4 during treatment period, week 6 and week 8 during follow-up period

• Change of self-rating anxiety scale (SAS) score

  week 2, week 4 during treatment period, week 6 and week 8 during follow-up period

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Drug: Jianpi Qinghua granules

Control group

SHAM COMPARATOR

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

Drug: Jianpi Qinghua placebo granules

Interventions

Jianpi Qinghua granules DRUG

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

Also known as: experimental drugs

Experimental group

Jianpi Qinghua placebo granules DRUG

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

Also known as: placebo

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects diagnosed with non-erosive reflux disease
• Subjects who have a medical history of PPI with poor therapeutic effect
• Subjects aged between 18 and 70 years
• Subjects diagnosed with spleen deficiency damp-heat syndrome of traditional Chinese medicine
• Subjects who voluntarily signed written informed consent form

You may not qualify if:

• Subjects who have active peptic ulcer, gastrointestinal hemorrhage, severe dysplasia of gastric mucosa or suspected malignant change, achalasia or postoperative achalasia
• 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
• 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
• Pregnant or lactating women
• Subjects who have a history of nervous system disease and mental disease
• Subjects who have a history of allergies to all the test drugs
• Subjects who are participating in other clinical trials or have participated in other clinical trials within 4 weeks

Sponsors & Collaborators

• Xiyuan Hospital of China Academy of Chinese Medical Sciences: lead
• Liaoning University of Traditional Chinese Medicine: collaborator
• First Teaching Hospital of Tianjin University of Traditional Chinese Medicine: collaborator

Study Sites (1)

Xiyuan Hospital

Beijing, Beijing Municipality, 100091, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 39839278 DERIVED

Study Officials

• beihua zhang, M.D

  Xiyuan Hospital of China Academy of Chinese Medical Sciences

  STUDY CHAIR

• guang bai, M.D

  Liaoning University of Traditional Chinese Medicine

  STUDY DIRECTOR

• wei wang, M.M

  First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

beihua zhang, M.D

CONTACT

+86(010)62835248; zhangbeihua888@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: March 27, 2020
• Study Start: July 15, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)