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

NCT04340297 | Unknown Phase 3 DMC

• 1 other identifier: 2019YFC1709604
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Traditional Chinese medicine; Tongjiang series prescription; Randomized controlled trial

Outcome Measures

Primary Outcomes (3)

• Changes of visual analogue (VAS) scores of reflow, heartburn and other major symptoms

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

  6 weeks during treatment period, 4 weeks during follow-up period

• Discontinuation rate of acid inhibitors

  Discontinuation rate of acid inhibitors = Number of drug discontinuation/ Total number of people in each group

  6 weeks of treatment

• The change of recurrence rate of main symptoms in Nonerosive Reflux Disease

  The recurrence rate of the main symptoms, such as heartburn and reflux, was evaluated respectively. The recurrence rate = Number of symptom recurrence / Number of drug discontinuation.

  6 weeks of treatment, 4 weeks during follow-up period

Secondary Outcomes (6)

• Changes in secondary symptom scores

  6 weeks during treatment period, 4 weeks during follow-up period

• Changes of Traditional Chinese Medicine syndrome score

  Baseline, 2 weeks, 4 weeks and 6 weeks during treatment period, 2 weeks and 4 weeks during follow-up period

• Changes of Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) scale scores

  Baseline, 2 weeks, 4 weeks and 6 weeks during treatment period, 2 weeks and 4 weeks during follow-up period

• The change of the score of chronic gastrointestinal disease patient reported outcome (PRO) scale

  Baseline, 2 weeks, 4 weeks and 6 weeks during treatment period, 2 weeks and 4 weeks during follow-up period

• The change of Self-rating anxiety scale (SAS) score

  Baseline, 2 weeks, 4 weeks and 6 weeks during treatment period, 2 weeks and 4 weeks during follow-up period

Study Arms (2)

Experimental group

EXPERIMENTAL

Tongjiang granules are taken orally in liver-stomach depression-heat syndrome, Jianpi Qinghua granules are taken orally in spleen deficiency damp-heat syndrome, Wenpi Qingwei granules are taken orally in cold-heat complicated syndrome, one bag per time, 3 times a day and 1 hour after a meal. At the same time, it was combined with acid inhibitors to reduce the steps of withdrawal treatment: 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: Tongjiang series prescription(Tongjiang granules, Jianpi Qinghua granules and Wenpi Qingwei granules); Drug: Acid inhibitors

Control group

PLACEBO COMPARATOR

Tongjiang placebo granules are taken orally by patients with liver-stomach depression-heat syndrome, Jianpi Qinghua placebo granules are taken orally by patients with spleen deficiency damp-heat syndrome, Wenpi Qingwei placebo 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. At the same time, it was combined with acid inhibitors to reduce the steps of withdrawal treatment: 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: Acid inhibitors; Drug: Placebo

Interventions

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

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.

Experimental group

Acid inhibitors DRUG

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.

Control group; Experimental group

Placebo DRUG

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.

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:

• \. It meets the diagnostic criteria of nonerosive reflex disease(NERD)
• \. Patients with PPIs who are effective for more than 8 weeks and relapse after discontinuation
• \. Age between 18 and 70 years old
• \. It meets the diagnostic criteria of liver-stomach depression-heat syndrome, spleen deficiency damp-heat syndrome and cold-heat complicated syndrome of traditional Chinese medicine
• \. Patients have informed consent and are willing to receive corresponding treatment

You may not qualify if:

• \. Patients with active peptic ulcer, gastrointestinal hemorrhage, severe dysplasia of gastric mucosa or suspected malignant change, achalasia or postoperative achalasia
• \. There are other 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
• \. Patients with 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 and lactating women
• \. Patients with history of nervous system disease and mental disease
• \. People with 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
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator
• Wuhan No.1 Hospital: collaborator
• The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine: collaborator
• Traditional Chinese Medicine Hospital of KUNSHAN: collaborator
• Liuzhou Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, China

RECRUITING

Related Publications (1)

• Li X, Wu H, Zhang B, Chen T, Shi X, Ma J, Zhang J, Tang X, Wang F. Traditional Chinese medicine based on Tongjiang methodology combined with proton pump inhibitor (PPI) step-down in treating non-erosive reflux disease: a study protocol for a multicentered, randomized controlled clinical trial. Trials. 2022 Oct 18;23(1):879. doi: 10.1186/s13063-022-06811-x.

  PMID: 36258217 DERIVED

Study Officials

• Xudong Tang, M.D.

  China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingpan Zhao, M.D.

CONTACT

+86(010)62835101; zypzyp1984@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 9, 2020
• Study Start: June 15, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2021
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

CN (1)