Ignite Creation Date:
2024-07-17 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466044
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-14
Brief Title:
Effect and Mechanism of Auricular Point Stimulation on Functional Dyspepsia With Sleep Disorder
Sponsor:
The First Affiliated Hospital of Zhejiang Chinese Medical University
Organization:
The First Affiliated Hospital of Zhejiang Chinese Medical University
Study Overview
Official Title:
Effect and Mechanism of Auricular Point Stimulation on Functional Dyspepsia With Sleep Disordera Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
Functional dyspepsia refers to a chronic digestive system disease with upper abdominal symptoms originating from the gastroduodenal region and after clinical examination including upper gastrointestinal endoscopy the organic diseases causing the above symptoms are excluded According to Rome IV standard functional dyspepsia can be divided into two categories postprandial discomfort syndrome and epigastric pain syndrome FD not only seriously affects the quality of life of patients but also causes a heavy social and economic burden Therefore active prevention and treatment of FD especially PDS has become an unavoidable problem in clinic
Epidemiological investigation shows that about 30 FD patients have many negative emotions such as sleep disorder anxiety and depression and many anti-negative emotional drugs themselves can cause gastrointestinal side effects which are considered to be the key reasons for the recurrence of symptoms In recent years people have paid more and more attention to the brain-gut axis Microbial-intestinal-brain axis can also affect brain function by releasing neurotransmitters and inflammatory mediators In addition the interaction between bile acids and intestinal microflora may also affect the normal function of the intestine However the relationship between specific bile acids microflora and functional dyspepsia is still uncertain
At present the effective and safe treatment methods for FD with sleep disorder are still very limited In recent years auricular point pressing bean therapy has obvious advantages in treating FD with sleep disorder This study plans to study the clinical efficacy and mechanism of auricular point stimulation on functional dyspepsia with sleep disorder Provide more treatment methods and ideas for clinicians popularize and apply green diagnosis and treatment methods bring good news to more patients and produce remarkable economic and social benefits
Epidemiological investigation shows that about 30 FD patients have many negative emotions such as sleep disorder anxiety and depression and many anti-negative emotional drugs themselves can cause gastrointestinal side effects which are considered to be the key reasons for the recurrence of symptoms In recent years people have paid more and more attention to the brain-gut axis Microbial-intestinal-brain axis can also affect brain function by releasing neurotransmitters and inflammatory mediators In addition the interaction between bile acids and intestinal microflora may also affect the normal function of the intestine However the relationship between specific bile acids microflora and functional dyspepsia is still uncertain
At present the effective and safe treatment methods for FD with sleep disorder are still very limited In recent years auricular point pressing bean therapy has obvious advantages in treating FD with sleep disorder This study plans to study the clinical efficacy and mechanism of auricular point stimulation on functional dyspepsia with sleep disorder Provide more treatment methods and ideas for clinicians popularize and apply green diagnosis and treatment methods bring good news to more patients and produce remarkable economic and social benefits
Detailed Description:
1 Determine the response rate based on the improved FDSD questionnaire and the results of the overall treatment effect The modified FDSD questionnaire is defined as the proportion of patients whose improved FDSD is reduced by 5 after 2 weeks of treatment compared with baseline and OTE is defined as extremely improved and improved symptoms after 2 weeks of treatment compared with baseline When there are differences between the two it is defined as having therapeutic effect
2 Treatment response rate at 8 weeks
3 Evaluate the functional dyspepsia of patients with functional dyspepsia and sleep disorder by 10 items of Nipin dyspepsia index
4 The Pittsburgh Sleep Quality Index Insomnia Severity Index Questionnaire and Self-assessment Anxiety Scale were used to evaluate the patients clinical sleep and psychological status
5 Objectively record the clinical sleep changes of the patients before and after treatment by the ActiGraph wGT3X-BT
6 Assess the autonomic nervous function of patients before and after treatment by the excessive arousal scale and heart rate variability
7 To study the therapeutic mechanism of patients before and after treatment by detecting fecal intestinal microecological flora and Short-chain fatty acid spectrum metabonomics
8 The changes of tongue and pulse before and after treatment were detected by tongue and pulse meter
2 Treatment response rate at 8 weeks
3 Evaluate the functional dyspepsia of patients with functional dyspepsia and sleep disorder by 10 items of Nipin dyspepsia index
4 The Pittsburgh Sleep Quality Index Insomnia Severity Index Questionnaire and Self-assessment Anxiety Scale were used to evaluate the patients clinical sleep and psychological status
5 Objectively record the clinical sleep changes of the patients before and after treatment by the ActiGraph wGT3X-BT
6 Assess the autonomic nervous function of patients before and after treatment by the excessive arousal scale and heart rate variability
7 To study the therapeutic mechanism of patients before and after treatment by detecting fecal intestinal microecological flora and Short-chain fatty acid spectrum metabonomics
8 The changes of tongue and pulse before and after treatment were detected by tongue and pulse meter
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