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NCT06881524
Low-Dose Amoxicillin Dual-Therapy Combined with Licorice and Lotus Root Powder Helicobacter Pylori Treatment
NA trial testing First-line licorice and lotus root powder combined with low-dose amoxicillin in HELICOBACTER PYLORI INFECTIONS in 374 participants. Not yet recruiting.
1 July 2025
Quick facts
| Lead sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 374 |
| Start date | 1 April 2025 |
| Primary completion | 1 July 2025 |
| Estimated completion | 1 August 2025 |
Drugs / interventions tested
- First-line licorice and lotus root powder combined with low-dose amoxicillin — full drug profile →
- First line high-dose amoxicillin — full drug profile →
- Rescue licorice and lotus root powder combined with low-dose amoxicillin — full drug profile →
- Rescue high-dose amoxicillin — full drug profile →
Conditions studied
- HELICOBACTER PYLORI INFECTIONS — all drugs for HELICOBACTER PYLORI INFECTIONS →
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Who can join
Adults 18 to 70, any sex, with HELICOBACTER PYLORI INFECTIONS. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In recent years, the increasing prevalence of Helicobacter pylori (H. pylori, Hp) resistance has led to a gradual decline in the eradication rate of Hp. The growing resistance to antibiotics, particularly clarithromycin, has severely impacted the efficacy of Hp eradication. Dual-therapy regimen consisting of a proton pump inhibitor (PPI) and amoxicillin can overcome clarithromycin resistance in Hp and is effective for Hp treatment. Vonoprazan, a novel potassium-competitive acid blocker (P-CAB), has a stronger and more sustained inhibitory effect on gastric acid secretion compared to traditional PPIs. Dual-therapy regimens combining P-CABs and high-dose amoxicillin have demonstrated high eradication rates. However, the adverse effects associated with high-dose amoxicillin, such as nephrotoxicity, limit the application of this regimen. Our recent in vitro bacterial experiments and animal studies have shown that licorice, a traditional Chinese herbal medicine that is also used as a food, can inhibit the growth of Hp. This study is designed to compare a licorice-containing treatment regimen with a low-dose amoxicillin dual-therapy regimen in a clinical RCT to explore the efficacy of the former in Hp infection treatment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06881524
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Related trials
Other recruiting trials for HELICOBACTER PYLORI INFECTIONS
Currently open trials in the same condition.
- NCT07293910 — Vonoprazan vs Proton Pump Inhibitor With Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Py · Phase 2 · recruiting
- NCT07335406 — Registry for the Management of Helicobacter Pylori Infection in Shandong Province · recruiting
- NCT07346521 — Endoscopic Screening of Asymptomatic Patients for Helicobacter Pylori, Intestinal Metaplasia, and Barrett's Mucosa Durin · recruiting
- NCT07246681 — Lignin in Treatment of Helicobacter Pylori Infection · Phase 3 · active not recruiting
- NCT07179159 — Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication · NA · recruiting
Other Second Affiliated Hospital, School of Medicine, Zhejiang University trials
Trials by the same sponsor.
- NCT07445152 — Research on Construction and Verification of Multimodal Medical Imaging Large Model · not yet recruiting
- NCT06775665 — A Real-World Study on Hypertrophic Cardiomyopathy in Chinese Population · not yet recruiting
- NCT07533422 — Rescue Reatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing · NA · not yet recruiting
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- NCT07505186 — Camrelizumab, Chemotherapy and Ivarmacitinib in Patients With Resectable Esophageal Squamous Cell Carcinoma · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06881524 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Second Affiliated Hospital, School of Medicine, Zhejiang University
- Last refreshed: 18 March 2025
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