Ignite Creation Date:
2024-05-06 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05353933
Status:
COMPLETED
Last Update Posted:
2022-07-28
First Post:
2022-04-16
Brief Title:
Efficacy and Safety of Thread Embedding Acupuncture in Treating Gastroesophageal Reflux Disease
Sponsor:
University of Medicine and Pharmacy at Ho Chi Minh City
Organization:
University of Medicine and Pharmacy at Ho Chi Minh City
Study Overview
Official Title:
Efficacy and Safety of Thread Embedding Acupuncture Combined With PPI in Treating GERD
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 TEAs side effects it will be assessed regularly during the 4-week intervention
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 TEAs side effects it will be assessed regularly during the 4-week intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None