CClinicalTrials.gg
Status unknownNCT03971383Updated Jun 3, 2019

Phase Ⅱc Sutdy of Aolanti Weikang Tablets in FD PDS Patients

A Phase 2 interventional study of Aolanti Weipang Tablets and Placebo in Functional Dyspepsia, sponsored by Jiangxi Qingfeng Pharmaceutical Co. Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-06-03.

Sponsored by Jiangxi Qingfeng Pharmaceutical Co. Ltd. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
236
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and validity of Aolanti Weipang Tablets in Patients with Postprandial Discomfort Syndrome of Functional Dyspepsia

Read the detailed description

This is a multi-center, randomized, double blind, placebo-controlled phase Ⅱc study to evaluate the safety and validity of Aolanti Weipang Tablets in patients with postprandial discomfort syndrome of Functional Dyspepsia(FD). This study will consecutive about 12 weeks, including 2 weeks of screening, 1 week of blank run-in, 1 week of placebo run-in, 4 weeks of double blind treatment and 4 weeks of observation after treatment. The subjects will be randomly given orally Aolanti Weikang Tablets or placebo tablets at a 1:1 ratio three times a day(tid) with 3 tablets one time for the treatment.

02

Conditions studied

  • Functional Dyspepsia

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03

In context

Dyspepsia

363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.

This study's planned enrollment of 236 is above the median of 87 across 297 interventional studies indexed under Dyspepsia.

Browse Dyspepsia studies →

Lead sponsor

Jiangxi Qingfeng Pharmaceutical Co. Ltd. is the lead sponsor of 32 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients diagnosed with FD according to the ROME Ⅳ criteria,and must with symptom of bothersome postprandial fullness;
  • Patients diagnosed with Stagnation of Qi according to traditional Chinese medicine;
  • At least the symptom of bothersome postprandial fullness ≥4 on the Visual Analogue Scale(VAS), and the number of recurrence day must ≥3 in one week;
  • Provides voluntary informed consent after receiving adequate explanation and demonstrates thorough understanding of the nature of the study.

Exclusion criteria

Exclusion Criteria:

  • The patients with high placebo effect, the scores in placebo run-in stage declined much than 30 percent of the mean VAS per week compare to blank run-in stage;
  • Unable to take drugs orally;
  • Within 7 days of Screening, the average number of stool > 2 times/day;
  • Within 7 days of Screening, with the presence of ≥ type 5 stool form per the Bristol Stool Form Scale;
  • History of drug or aurantium allergy;
  • Patients with positive in fecal occult blood test;
  • Abnormal liver and/or kidney function: creatinine >1.5*ULN (upper limits of normal), and/or AST and/or ALT > 2.0*ULN, and/or TBil > 1.5*ULN;
  • Patients with family history of prolonged QT syndrome or have history of torsional apical ventricular tachycardia; or QTc > 480 ms;
  • Digestive diseases, or other diseases within 6 months before Screening that may affect the swallow, absorption, or metabolism of study drugs, and not yet fully recovered judged by the Investigator;
  • Patients who positive in H. Pylori test plan to accept the H. pylori eradication therapy within the trial;
  • Serious complications (heart, brain, lung, liver, kidney, or blood disease);
  • Neuropsychiatric disorders;
  • Use of prohibited medications;
  • Pregnant or lactating women or those who are planning to conceive during the study period;
  • Drug abuse within 3 months, or alcohol abuse within 6 months;
  • Patients participated in other clinical trials within 30 days before taking drugs;
  • Other conditions deemed ineligible for enrollment by Investigator.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
236 participants (estimated)

Study arms

  • Experimental
    Aolanti Weipang Tablets

    3 tablets one time, 3 times a day(tid)

    Drug: Aolanti Weipang Tablets

  • Placebo comparator
    Placebo

    3 tablets one time, 3 times a day(tid)

    Drug: Placebo

Interventions

  • DrugAolanti Weipang Tablets

    3 tablets one time, 3 times a day(tid)

  • DrugPlacebo

    3 tablets one time, 3 times a day(tid)

06

What researchers measure

Primary outcomes

  1. The response rate of patient's on the syndrome of postprandial discomfort

    the response rate of patients on the syndrome of postprandial discomfort, patient's evaluation of symptomatic improvement by overall treatment efficacy is classified by 7 point Likert scale: Significantly improved Improved Slightly improved No change Slightly worse Worse Much worse And only the Improved and Significantly improved classified as responsed.

    Time frame: 4 weeks

Secondary outcomes

  1. The response rate of patient's on the syndrome of postprandial discomfort and early satiation

    the response rate of patient's on the syndrome of postprandial discomfort and early satiation

    Time frame: 8 weeks

  2. The response rate of patient's on the syndrome of early satiation

    the response rate of patient's on the syndrome of early satiation

    Time frame: 8 weeks

  3. The safety of Aolanti Weikang Tablets on patients

    Number and grade of treatment-related adverse events, all of theAE are assessed by NCI-CTCAE

    Time frame: 8 weeks

07

Study locations

1 site
  • The Second People's Hospital of Fujian Province
    Fuzhou, Fujian, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03971383
Lead sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Responsible party
Sponsor
First posted
Jun 3, 2019
Start date
Jun 10, 2019 (estimated)
Primary completion
Oct 31, 2020 (estimated)
Completion
May 3, 2021 (estimated)
Last update
Jun 3, 2019

Study contacts

Qinsheng Zhang
Contact
zhangqinsheng@sh-qingfeng.net
+86-18036618691
Lihua Qing
Contact
qinglihua@sh-qingfeng.net
+86-17717385428
Xiao Ke
principal investigator · The Second People's Hospital of Fujian Province

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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