To investigate the therapeutic effect of Chaihu Shugan Powder in the treatment of Laryngopharyngeal reflux disease based on the theory of microbiota-gut-brain axis

To investigate the therapeutic effect of Chaihu Shugan Powder in the treatment of reflux laryngitis based on the theory of microbiota-gut-brain axis

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300072440

Enrollment

Unknown

Registered

2023-06-14

Start date

2023-06-12

Completion date

Unknown

Last updated

2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngopharyngeal reflux disease

Interventions

Experimental group:Experimental group: uniform diet before treatment + Chaihu Shugan Powder + esomeprazole magnesium enteric-coated tablets. Chaihu Shugan Chinese medicine drugs (composition: Chaihu 1

Control group:Control group drug: esomeprazole magnesium enteric-coated tablets: 20mg bid po (Jiangxi Shanxiang Pharmaceutical Co., Ltd.). Treatment for 8 weeks.

Groups of healthy people:uniform diet before treatment

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: LPRD patients: (1) age: 18-80 years old; (2) RSI>13 and/or RFS>7; (3) 24h laryngeal acid reflux event = 3 times or of laryngeal pH value 6.3; (4) Have not used any antibiotics, PPIs, probiotics and prebiotics within 3 months before enrollment; (5) The routine examination of stool is normal, and there are no intestinal flora disorders such as diarrhea and abdominal distention; (6)BMI<24. Healthy people: (1) Age: 18-80 years old; (2) No symptoms of throat disease.

Exclusion criteria

Exclusion criteria: (1) acute and chronic infection;(2) other acute and chronic intestinal diseases other than gastroesophageal reflux; (3) Patients with malignant tumors of the head or neck;(4) Endocrine system diseases (diabetes and obesity, etc.);(5) Accompanied by severe cardiovascular and cerebrovascular diseases or systemic infectious diseases or organ failure;(6) Those who are allergic to constitution, or those who are known to be allergic to the ingredients of this drug;(7) Those who cannot give full informed consent due to intellectual disabilities;(8) Suspected history of alcohol or drug abuse.

Design outcomes

Primary

Measure	Time frame
RSI score;VAS score;	—

Secondary

Measure	Time frame
RFS score;Bioinformatic analysis of fecal flora;	—

Countries

China

Contacts

Public ContactChen Wenyong

Guangdong Provincial Hospital of Traditional Chinese Medicine

wenyongch@163.com+86 137 1032 8628

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026