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A randomized controlled clinical study of the efficacy and safety of Cidine in combination with Tegoprazan in the treatment of gastroesophageal reflux disease in patients with ineffective esophageal motility

A randomized controlled clinical study of the efficacy and safety of Cidine in combination with Tegoprazan in the treatment of gastroesophageal reflux disease in patients with ineffective esophageal motility

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078699
Enrollment
Unknown
Registered
2023-12-15
Start date
2024-01-01
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

gastroesophageal reflux disease

Interventions

control group:Tegoprazan for 8 weeks
experimental group:Cidine in combination with Tegoprazan for 8 weeks

Sponsors

The Seventh Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Willing to sign informed consent; Meeting the diagnosis of gastroesophageal reflux disease: patients with typical symptoms such as heartburn and reflux, meeting the diagnosis of GERDQ questionnaire or proton pump inhibitor diagnostic therapy for 2 weeks, or atypical symptoms but reflux confirmed by 24-hour esophageal PH+ impedance monitoring; Endoscopic evidence of reflux; Ages 18 to 75, gender unlimited; The course of the disease is more than 6 months; Patients with ineffective oesophageal motility were diagnosed according to manometry for oesophageal motility disorders (4th edition Chicago Classification).

Exclusion criteria

Exclusion criteria: Autoimmune diseases affecting gastrointestinal motivity, such as scleroderma, dermatomyositis, and central or peripheral nervous system diseases, after cardiac radiofrequency ablation, etc; High resolution esophageal manometry ruled out diffuse esophageal spasm, achalasia of cardia, EGJ outflow tract obstruction; Gastroscopy to rule out organic diseases of the stomach and esophagus (such as esophageal cancer); History of gastric or esophageal surgery, including patients after endoscopic or laparoscopic fundoplication; Serious complications (such as uncontrolled hypertension, gastrointestinal bleeding, severe cardiopulmonary, liver, kidney, hematopoietic diseases, etc.); Severe comorbiditions (such as uncontrolled hypertension, gastrointestinal bleeding, severe cardiopulmonary, liver, kidney, hematopoietic diseases, etc.) can not stop alcohol abuse during the study period (equivalent to alcohol dose =40g/day for men and =20g/day for women); Pregnant women who are breastfeeding or women whose pregnancy is not ruled out; Known allergy to this ingredient; The researchers found it unsuitable for participants.

Design outcomes

Primary

MeasureTime frame
DCI LES;Lower esophageal sphincter (LES);Healing of esophageal mucosa;

Secondary

MeasureTime frame
Symptoms of patients with gastroesophageal reflux disease;Quality of life in patients with gastroesophageal reflux disease;

Countries

China

Contacts

Public ContactJian Qi

The Seventh Affiliated Hospital, Sun Yat-sen University

qijian@sysush.com+86 186 2772 9596

Outcome results

None listed

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