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Study on the mechanism of Lingnan fire needling on brain gut axis in functional dyspepsia with liver depression and spleen deficiency syndrome

Study on the mechanism of Lingnan fire needling on brain gut axis in functional dyspepsia with liver depression and spleen deficiency syndrome

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005398
Enrollment
Unknown
Registered
2021-12-12
Start date
2021-12-12
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:Fire needle intervention scheme was adopted.
Control group:Mosapride intervention scheme was adopted.

Sponsors

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Age between 18-65 years old; 2) Accord with the diagnostic criteria of functional dyspepsia; 3) Accord with the syndrome of liver depression and spleen deficiency in traditional Chinese medicine; 4) The frequency and severity of symptoms of functional dyspepsia were above grade II; 5) Patients volunteered to participate in the study, signed informed consent and were willing to cooperate with the study.

Exclusion criteria

Exclusion criteria: 1) Patients who had received functional dyspepsia drugs or acupuncture treatment within 2 weeks before screening; 2) Patients who underwent any surgery within 2 weeks before screening; 3) Patients with diabetes, coagulation disorders or severe skin diseases 4) During screening examination, the alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of the patient is greater than or equal to 1.5 times of the upper limit of normal value specified by the center, or the endogenous creatinine clearance (CCR) is greater than the upper limit of normal value specified by the center; 5) During screening examination, the total white blood cell count (WBC) of patients is greater than 10.0x109/l or less than 1.0x109/l; 6) The patient has a history of immune deficiency diseases (such as HIV), or a history of cancer, malignant tumor, or autoimmune diseases, or serious cardiovascular and cerebrovascular diseases, or other diseases that may significantly reduce life expectancy; 7) Have any history of diseases that may affect program compliance (such as severe mental disorders, cognitive impairment, drug abuse or addiction); 8) Pregnant or lactating women, or those who are unwilling / unable to take effective contraceptives; 9) Those who are known to be allergic to the ingredients contained in the drug used in this study; 10) Those who have participated in any drug clinical trial within 6 months before screening examination; 11) The investigator judged that patients should not participate in this study

Design outcomes

Primary

MeasureTime frame
Clinical effective rate;Overall symptom score;

Secondary

MeasureTime frame
5-hydroxytryptamine;Motilin;

Countries

China

Contacts

Public ContactShaoqiongChang
changshaoqiong90280@gzucm.edu.cn13631396263

Outcome results

None listed

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