The clinical trial program of Zhi Zhu Kuan Zhong capsules

A randomized, double-blind, placebo-controlled, multi-center clinical trial of Zhizhukuanzhong capsule in treatment of functional dyspepsia (postprandial distress syndrome)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-14004714

Enrollment

Unknown

Registered

2014-05-26

Start date

2014-06-03

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 (Postprandial distress syndrome)

Interventions

Group A:Zhi Zhu Kuan Zhong capsule

Group B:Zhi Zhu Kuan Zhong capsule placebo

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) comply with the diagnostic criteria of Rome III functional dyspepsia of postprandial distress syndrome; (2) At least one score (degree + frequency) of the main symptoms (postprandial fullness, early satiety)= 4; (3) The aged 18-65 years male or female outpatients; (4) Within six months prior to enrollment, perform endoscopy examination in the top three hospitals to exclude gastric ulcers, erosive gastritis, or other organic disorders of the stomach; (5) Within six months prior to enrollmentperform B-ultrasound in the top three hospitals to exclude hepatobiliary and pancreatic diseases; (6) Agreed to participate in the clinical trial and signed informed consent.

Exclusion criteria

Exclusion criteria: (1) there is a history of abdominal surgery; (2) Use drug that can impact gastrointestinal motility or gastric acid secretion or neutralize gastric acid, anti-Helicobacter pylori drugs within five days prior to enrollment; (3) The person who have hypertension and blood pressure is unstable; (4) Diabetes; (5) The person who have a istory of thyroid disease, systemic sclerosis, systemic lupus erythematosus; (6) The person who have severe mental disorders (HAD subscale score = 8); (7) Pregnant women, lactating women or those who planning to become pregnant; (8) The person who is allergy to Zhi Zhu Kuan Zhong capsule or its components; (9) The person who is combined with other gastrointestinal functional disorders (10) The person who participated in other clinical trials in the last three months.

Design outcomes

Primary

Measure	Time frame
Routine physical examination;Vital Signs;routine blood tests;Urine microscopy;liver function;Renal function;Fasting plasma glucose;ECG;Clinical symptom;	—

Countries

China

Contacts

Public ContactChen Minhu

Division of Gastroenterology, The First Affiliated Hospital, Sun Yat-sen University

chenminhu@vip.163.com+86 13802957089

Outcome results

None listed

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