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A Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical study to evaluate the efficacy of Chinese medicine on patients with functional dyspepsia by differential treatment of spleen

The Study on Mechanism, Diagnosis andTreatment Regularity of differential treatment of spleen for functional gastrointestinal diseases caused by dysfunction of the spleen

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003200
Enrollment
Unknown
Registered
2013-04-19
Start date
2013-06-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Functional dyspepsia

Interventions

Treatment Group:Pixu 1 decoction
Treatment Group:Pixu 2 Decoction
Treatment Group:Pixu 3 decoction
Control Group:Placebo

Sponsors

Xiyuan Hospital Affiliated to China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Fulfill the diagnostic criteria of functional dyspepsia of Rome III criteria; (2) Between 18 years to 70 years; (3) Sign the informed consent and will to accept corresponding intervention.

Exclusion criteria

Exclusion criteria: 1. Patients accompany with serious lesion of heart, kidney, liver and other main organ, hematopoietic system diseases and tumor.(Notice to identify angina pectoris.); 2. Patients with organic diseases of digestive system (such as chronic pancreatitis, liver cirrhosis, etc), or systemic diseases influencing gastrointestinal power (e.g. hyperthyroidism, diabetes, chronic renal insufficiency, mental and neurological, etc); 3. Take drugs affecting the gastrointestinal function continuous within a week. (such as H2RA, PPI, gastric mucosal protective drugs, anti-acid drugs, gastrointestinal agent drugs and so on ); 4. Patients allergic to the drugs; 5. Pregnant or lactating females; 6. History of psychiatric or nervous system disease; 7. Patients taking part in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Evaluation of the severity of the uncomfortable feeling after meal;clinical global impression scale;

Secondary

MeasureTime frame
TCM sympotoms scores;short form 36 health survey scale;

Countries

China

Contacts

Public ContactXudong Tang
kangnan.1988@163.com+86 13901137632

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 3, 2026