Efficacy & Safety of Thread Embedding Acupuncture in Treating

Status Completed

Clinical Trial Summary

Gastroesophageal reflux disease is a very common disease nowadays. Proton-pump inhibitors (PPIs) are the first-line treatment for this disease. However, the effectiveness of treatment with PPIs is still limited. Acupuncture has been shown to be effective in treating this condition. Another treatment method is thread embedding acupuncture therapy, which is a method of burying threads into acupoints to create a more lasting stimulation than traditional acupuncture. This study will evaluate the efficacy and safety of the combination of thread embedding acupuncture and standard dose pantoprazole compared with standard dose pantoprazole as monotherapy in adults.

Clinical Trial Description

Patients with GERD diagnosed based on the GerdQ score who meet the inclusion criteria and do not meet the exclusion criteria will be included in the study. After randomization, patients will be divided into 2 groups: control group and intervention group. In both groups, patients will be treated for GERD according to current guidelines including PPIs, additional antacids as needed, and lifestyle changes. The intervention group will include additional thread embedding acupuncture therapy (TEA) twice on day 0 and day 14th. Intervention duration is 4 weeks. The objectives of the study are to evaluate the improvement of GERD symptoms by using the evaluation score including Gastroesophageal reflux disease questionnaire (GerdQ) and Frequency Scale for the Symptoms of GERD (FSSG); the evaluation score of Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) will be used to evaluate the improvement of quality of life; and evaluate the safety of TEA in the treatment of GERD. All scales will be evaluated before and after the intervention. For the GerdQ score, patients will be assessed weekly, every 2 weeks for FSSG and GERD-HRQL during the 4-week intervention. For TEA's side effects, it will be assessed regularly during the 4-week intervention. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05353933
Study type	Interventional
Source	University of Medicine and Pharmacy at Ho Chi Minh City
Contact
Status	Completed
Phase	N/A
Start date	May 4, 2022
Completion date	July 20, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05561179` - Hyaluronic Acid in Patients With Gastroesophageal Reflux Disease	N/A
Withdrawn	`NCT02213887` - Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications	Phase 4
Completed	`NCT01946971` - Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)	Phase 1/Phase 2
Recruiting	`NCT01825473` - Study of Erythromycin in GER-Associated Apnea of the Newborn	N/A
Completed	`NCT00614536` - Study of Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period	Phase 4
Completed	`NCT00365300` - Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)	Phase 3
Completed	`NCT00373997` - Esophageal and Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux	Phase 4
Completed	`NCT00284908` - Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers	Phase 1
Completed	`NCT00226044` - Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.	Phase 3
Completed	`NCT00291746` - Validation of RDQ Questionnaire	Phase 4
Completed	`NCT01167543` - Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease	N/A
Completed	`NCT00567021` - German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms	N/A
Completed	`NCT00141960` - Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease	Phase 2/Phase 3
Completed	`NCT00215787` - Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease	N/A
Completed	`NCT01048840` - Natural History of Gastroesophageal Reflux (GER) in Children < 12 Years of Age
Completed	`NCT00181805` - Natural History of Gastroesophageal Reflux (GER) in Children and Adolescents
Terminated	`NCT01281553` - A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease	Phase 4
Completed	`NCT05486169` - Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy	N/A
Completed	`NCT04034017` - Gastroesophageal Reflux Disease Among College Students
Terminated	`NCT03226054` - Determining Risk Factors for Successful PPI Weaning	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Efficacy and Safety of Thread Embedding Acupuncture in Treating Gastroesophageal Reflux Disease

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms