Last reviewed · How we verify
A Multi-center, Randomized, Double-Blind, Placebo-Controlled Parallel Group Clinical Trial of Zhizhu Kuanzhong Capsule in Treating Patients With Postprandial Distress Syndrome of Functional Dyspepsia
This trial aims to evaluate the clinical efficacy and safety of Zhizhu Kuanzhong Capsule in the treating patients with functional dyspepsia postprandial distress syndrome(FD PDS). Half of participants will receive Zhizhu Kuanzhong Capsule,while the other will receive a placebo.
Details
| Lead sponsor | Xiyuan Hospital of China Academy of Chinese Medical Sciences |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 480 |
| Start date | 2019-10-24 |
| Completion | 2023-12 |
Conditions
- Functional Dyspepsia
- Postprandial Distress Syndrome
Interventions
- Zhizhu Kuanzhong Capsule
- Zhizhu Kuanzhong Placebo Capsule
Primary outcomes
- The proportion of the response at 8 weeks after randomization — up to 8 weeks
Subjects with the functional dyspepsia-postprandial distress syndrome are self-rated on the Visual Analogue Score (VAS) which is a scale of 0-10, with subjects indicating the degree of discomfort on a 10 cm ruler marked 0- "Asymptomatic or No Discomfort "to 10- "Extreme Severe or Extreme Discomfort "at its head and tail, respectively. The record is made once a day and 7 days a week via a diary card. For VAS scores for postprandial fullness discomfort and early satiety, the integral average for both symptoms over the past week is evaluated, and a 50% decrease from baseline in the integral average at 8 Weeks is recorded as a response.
Countries
Australia, China