to comapre the efficacy of two Zhizhu pills in the treatment of functional dyspepsia of spleen-deficiency and qi-stagnation syndrome

to comapre the efficacy of two Zhizhu pills(containing immature orange fruit of Citrus aurantium L.(IFCA) and that of Citrus sinensis Osbeck(IFCS)) in the treatment of functional dyspepsia of spleen-deficiency and qi-stagnation syndrome:a randomized group sequential trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-09000485

Enrollment

Unknown

Registered

2009-08-14

Start date

2003-06-01

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 of spleen-deficiency and qi-stagnation syndrome

Interventions

IFCA group:Zhizhu pills containing IFCA 6g, orally taken three times daily for 28 days

IFCS group:Zhizhu pills containing IFCS 6g, orally taken three times daily for 28 days.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Functional dyspepsia of spleen-deficiency and qi-stagnation syndrome according to Rome-II criteria and Guidance principle of clinical study on new drug of traditional Chinese medicine(TCM); 2. TCM syndrome integral>=8; 3. Aged 18 to 65 years old; 4. Able and willing to provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients demonstrating gastric ulcer or duodenal ulcer on upper gastrointestinal endoscopy, gastroesophageal reflux disease with typical symptoms like heartburn or acid regurgitation, malignant diseases; 2. Patients with serious hepatic, cardiovascular, renal, or hematological diseases. 3. Pregnancy; Breast feeding women; 4. History of hypersensitivity to Zhizhu pills.

Design outcomes

Primary

Measure	Time frame
the cure-markedly effective rate;	—

Secondary

Measure	Time frame
Gastric Emptying;The serum content of gastrin(GAS);The plasma content of motilin(MTL);	—

Countries

China

Contacts

Public ContactHongxin Cao

caohongxin58@yeah.net+86 010 64014411

Outcome results

None listed

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