Study on Syndrome Rules of Stagnated Heat in Liver and Stomach of Non-Erosive Reflux Disease Based on Microecology of Tongue Coating

Phase 1

Recruiting

• Conditions: on-erosive reflux disease

• Registration Number: ITMCTR2100004734
• Lead Sponsor: Fangshan Hospital of Beijing University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Inclusion criteria for the syndrome of stagnated heat in liver and stomach and syndrome of qi stagnation and phlegm stagnation syndrome:
(1) Western medicine diagnosis is consistent with non-erosive reflux disease;
(2) TCM syndrome differentiation refers to the syndrome of stagnated heat in liver and stomach and the syndrome of qi stagnation and phlegm stagnation;
(3) Those aged between 18 and 65 years old;
(4) Anyone who voluntarily participates in and signs the informed consent form.
2. Inclusion criteria of normal control group:
(1) Healthy people (18–65 years old) with mild constitution in TCM and body mass index (BMI) of 18.5–23.9 (The diagnostic criteria of mild constitution refer to Classification and Determination of Constitution in TCM issued in 2009);
(2) There is no infectious disease or inflammation after medical examination.

Exclusion Criteria

1. Exclusion criteria for the syndrome of stagnated heat in liver and stomach and syndrome of qi stagnation and phlegm stagnation syndrome:
(1) Pregnant women or women preparing for pregnancy and lactating women;
(2) Those with allergic constitution and allergy to multiple drugs;
(3) Patients with severe primary diseases such as liver, kidney, hematopoietic system, endocrine system and mental illness;
(4) Severe cases requiring emergency treatment;
(5) Those who participated in other clinical trials within three months.
2. Exclusion criteria for normal control group:
(1) There are hepatitis, syphilis, HIV, schistosomiasis and other known infectious diseases;
(2) Has a history of gastroesophageal reflux disease;
(3) Acute gastroenteritis in recent 6 months;
(4) Taking antibiotics in the past three months;
(5) Nearly 6 months to infectious disease epidemic area;
(6) Nearly 6 months have smelting tour high risk sex life history;
(7) Gastrointestinal bleeding in the past three months;
(8) Constipation in recent 3 months;
(9) Laxatives and weight-loss drugs have been used in the past three months;
(10) Nearly three months after taking hormones and other immunosuppressive agents;
(11) Gastrointestinal polyposis, malignant tumor;
(12) Diabetes, hypertension, coronary heart disease and other chronic diseases;
(13) Liver cirrhosis and autoimmune diseases;
(14) Chronic obstructive pulmonary disease;
(15) Severe food allergy.

Study & Design

• Study Type: Observational study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tongue coating flora 16SrRNA gene;

Secondary Outcome Measures

Name	Time	Method
Symptom scale;