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Double-blind and double-simulated clinical study on "Tiaohezhizhong"acupuncture treatment of functional dyspepsia based on brain-intestine co-treatment theory

Double-blind and double-simulated clinical study on "Tiaohezhizhong"acupuncture treatment of functional dyspepsia based on brain-intestine co-treatment theory

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006508
Enrollment
Unknown
Registered
2022-08-18
Start date
2022-08-15
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional dyspepsia

Interventions

Experimental group:acupuncture + placebo
Control group :western medicine + sham acupuncture

Sponsors

The second affiliated Hospital of Anhui University of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meeting the diagnostic criteria of FD in accordance with Rome IV classification system; (2) between 18 and 65 years old, regardless of gender; (3) those who did not take FD-related drugs at least 15 days before the first treatment; (4) those who had good compliance and were able to fill in the scale by themselves; (5) signed informed consent and volunteered to participate in this subject, but did not participate in other clinical researchers. Patients who meet the above five criteria at the same time can be included in this study.

Exclusion criteria

Exclusion criteria: (1) symptoms of dyspepsia caused by other chronic diseases; (2) taking or are taking drugs or antibiotics that affect gastrointestinal motility or gastric acid secretion within half a month; (3) patients with severe brain, heart, liver, kidney, lung, hematopoietic system and endocrine system, autoimmune diseases; (4) malignant tumors or other serious consumptive diseases, infectious diseases, hemorrhagic diseases, etc. (5) patients with severe mental and psychological disorders (HAMA = 21 with obvious anxiety), (6) lactating women and women preparing for pregnancy or already pregnant. (7) the expectation of curative effect is too high, and there is no willingness to follow up. Anyone who conforms to any of the above shall be excluded from this study.

Design outcomes

Primary

MeasureTime frame
Fecal short-chain fatty acids;SP;5-HT;Nipin dyspepsia symptom index;Motilin;Nipin dyspepsia quality of life index;Efficacy evaluation of functional dyspepsia: effective / ineffective;TCM symptom score of functional dyspepsia;Gastric emptying rate;Hamilton anxiety scale;

Countries

China

Contacts

Public ContactHaoran Chu
chuhaoran62@163.com13855107535

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026