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Observation on anti-anxiety effect of Regulating Shen acupuncture therapy in the treatment of Functional dyspepsia

Not Applicable
Recruiting
Conditions
Functional dyspepsia
Registration Number
ITMCTR2100005193
Lead Sponsor
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1.Men or women aged from 18 to 60.
2.Meeting the Rome IV FD criteria.
3.Meeting the diagnostic criteria of GAD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
4.HAMA scale score ranged from 14 to 29.
5.No other gastrointestinal motive drugs or psychotropic drugs received within 2 weeks before treatment.
6.Understood the protocol and sign the informed consent.
7.Willing to receive treatment and fill in the questionnaire.

Exclusion Criteria

1.Reject to sign the informed consent.
2.Identify organic lesions of the digestive system, such as chronic non-atrophic gastritis with erosion, chronic atrophic gastritis, gastroduodenal polyps, chronic hepatitis, chronic pancreatitis.
3.Presence of serious structural disease (disease of heart, liver, or kidney).
4.Taking drugs related to the gastrointestinal function two weeks before participating in the trial, such as 5-HT receptor antagonists, anticholinergic drugs, antidepressants and calcium channel blockers.
5.Patients who are allergic to or have contraindications to mosapride that make them unsuitable to take the drug.
6.Patients who are not suitable for acupuncture, such as skin lesions at the acupuncture site, dizziness during acupuncture in the past, pneumothorax, spontaneous bleeding, etc.
7.Pregnant and lactating women.
8.Have a clear history of mental illness or accompanied by psychiatric symptoms, such as depression, schizophrenia, etc.
9.Patients who are afraid of acupuncture.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Hamilton Rating Scale for Anxiety (HAMA);
Secondary Outcome Measures
NameTimeMethod
Overall treatment effect;Functional Digestive Disorders Quality of Life Questionnaire (FDDQL);
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