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Clinical Study of Herbal Acupoint Application Combined With Paraffin Therapy in the Treatment of Functional Dyspepsia Based on the Warming Therapy

Phase 1
Conditions
Functional dyspepsia
Registration Number
ITMCTR2022000038
Lead Sponsor
Guang'anmen Hospital,China Academy of Chinese Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(1) Individuals who have one or more of the following symptoms: postprandial fullness, early satiation, epigastric pain, epigastric burning;
(2) Individuals who meet the diagnostic criteria of Rome IV for functional dyspepsia;
(3) Individuals who have normal esophagogastroduodenoscopy and Helicobacter pylori detection results within one year;
(4) Criteria fulfifilled for the last 3 months with symptom onset at least 6 months before diagnosis;
signed the written informed consent form;
(5) Aged 18–65 years (either sex);
(6) Individuals who did not take antacids, prokinetics, or traditional Chinese medicine within 1 week;
(7) Individuals who did not receive acupuncture, herbal acupoint application therapy or other traditional Chinese medicine treatment within 1 week;
(8) Individuals who voluntarily agree with a study protocol and sign a written informed consent;
(9) Individuals with stable vital signs.

Exclusion Criteria

(1) Individuals who combined with liver, gall bladder or pancreatic diseases;
(2) Individuals who combined with erosive gastritis, peptic ulcer or gastric tumor;
(3) Individuals with unstable vital signs;
(4) Individuals who cannot tolerate herbal acupoint application therapy;
(5) Legal disabled patients, lactating or pregnant women, or patients unable to correctly express subjective discomfort symptoms;
(6) Individuals who have a history of excessive drinking or drug abuse;
(7) Individuals who are unable to adhere to treatment.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
subjective-clinical-assessment of FD symptoms (SCA-FD);
Secondary Outcome Measures
NameTimeMethod
Hospital Anxiety depression Scale score(HADS);The changes in the mean skin temperature of the Ren channel, Du channel, and the Five Shu Points of the Stomach Meridian, and the Spleen Meridian.;Perceived Stress Scale (PSS);The MOS item short from health survey, SF-36;
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