Clinical Study of Jinsang Liyan Capsules Combined With Proton Pump Inhibitors in the Treatment of Laryngeal Reflux Disease (LPRD): a Randomized, Double-blind, Placebo-controlled Trial

NCT05879029 Phase 4 UNKNOWN

The goal of this clinical trial is to compare the efficacy of Jinsang Liyan capsule in combination with PPI versus PPI alone for the treatment of Laryngopharyngeal Reflux Disease (LPRD). Participants will be randomly assigned in a 1:1 ratio to the experimental group or the control group. The experimental group was treated with Jinsangliyan capsule + rabeprazole enteric-coated tablets, and the control group was treated with Jinsangliyan capsule placebo + rabeprazole enteric-coated tablets. Participants were followed up at 4 weeks and 8 weeks after taking the drug to evaluate the improvement of LPRD symptoms. Researchers will compare Experimental group and control group to see if Jinsang Liyan capsule combined with PPI treatment is superior to PPI treatment alone.

Details

Lead sponsor	Tongji Hospital
Phase	Phase 4
Status	UNKNOWN
Enrolment	72
Start date	2023-07-01
Completion	2024-12

Conditions

• Laryngopharyngeal Reflux

Interventions

• Jinsang Liyan Capsule; Rabeprazole enteric-coated tablets.
• Jinsang Liyan Capsule placebo; Rabeprazole enteric-coated tablets.

Primary outcomes

• total effective rate — 2 months
  Visual analogue scale (VAS) is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. Reflux Symptom Index (RSI) is a questionnaire that measures the severity of symptoms associated with laryngopharyngeal reflux (LPR). Symptom improvement rate = (VAS score before treatment - VAS score after treatment)/VAS score before treatment ×100% Obvious: Symptom improvement rate ≥80%; Or RSI≤13 points. Effective: 50% ≤ Symptom improvement rate \<80%; Or RSI decreased, but still \>13 points. Ineffective: Symptom improvement rate \<50%; Or no reduction in RSI. Total effective rate =\[(obvious + effective)/total cases\]×100%

Countries

China