DyspepsiaPhase 4NCT05030116
Clinical Trial for 'Shen Qu Xiao Shi' Oral Liquid in the Treatments of Children's Functional Dyspepsia
A Phase 4 study testing Shenqu Xiaoshi oral liquid and Domperidone suspension in people with Dyspepsia, run by Ruijin Hospital at 1 site in China.
Trial summary
With domperidone suspension as the control, the effect of shenqu xiaoshi oral liquid on functional dyspepsia in children was evaluated objectively through multi-center, randomized, double-blind and double-simulation experiment, which alleviated the clinical symptoms, restored and promoted the normal growth and… Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Shenqu Xiaoshi oral liquid and Domperidone suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteChina
- Study dates
- 26 Jun 2019to 23 May 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3-14 years, regardless of gender;
- Meet 1 or more conditions: (1) full after dinner; (2) early full; (3) abdominal pain, and defecation has nothing to do; After appropriate evaluation, symptoms cannot be fully explained by other diseases; Or have other symptoms of dyspepsia, but not caused by other diseases;
- Have symptoms at least 2 months before diagnosis and at least 4 days per month;
- During the 2-week leading-in period, no drugs were used to treat infantile anorexia and functional dyspepsia, and good eating habits were established. The patients were fed on time and still had the above-mentioned symptoms of anorexia and functional dyspepsia; The symptom score was 3.
- The legal guardian of the child should sign the informed consent form. If the child is 10 years old or older, they should sign the informed consent form and agree to participate in the study.
Who cannot join
- Anorexia and dyspepsia caused by anorexia or dyspepsia caused by the influence of certain drugs or other confirmed diseases, such as erosive gastritis and gastric ulcer;
- Children with severe malnutrition;
- Children with abnormal ecg, liver and kidney functions, nervous system, respiratory system and endocrine system considered by the investigator;
- Children with mental disorders, dementia and unclear speech;
- Lactose intolerance or allergy to drug ingredients, or allergy to traditional Chinese medicine;
- Children who have participated in other clinical trials or are participating in clinical trials of other drugs within 12 weeks; According to the judgment of the researchers, there are other diseases or conditions that reduce the possibility of enrollment or complicate enrollment, such as unstable living environment and inconvenient transportation, which are easy to cause loss and follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Comparison of Shenqu Xiaoshi Oral Liquid and Domperidone Suspension in the Treatment of Functional Dyspepsia in Children: a Randomized, Double-blind, Double-simulated, Multi-center Clinical Study
With domperidone suspension as the control, the effect of shenqu xiaoshi oral liquid on functional dyspepsia in children was evaluated objectively through multi-center, randomized, double-blind and double-simulation experiment, which alleviated the clinical symptoms, restored and promoted the normal growth and development of children.
- Conditions
- Dyspepsia
- Being tested
- Shenqu Xiaoshi oral liquid, Domperidone suspension
- Keywords
- functional dyspepsia, children, Traditional Chinese Medicine
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shenqu Xiaoshi oral liquidDrug
Shenqu Xiaoshi oral liquid
Domperidone suspensionDrug
Domperidone suspension
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Shenqu Xiaoshi oral liquid |
| Control Group | Active comparator | Not described Receives: Drug: Domperidone suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total effective rate
Measured: Treatment for two weeks
Secondary outcomes (6)
Clinical symptom scores
Measured: Treatment for one/two week(s)
Total effective rate
Measured: Two weeks after stopping the medication
Food intake
Food intake was measured by a scale filling by subjects or their parents. Scores range from 0 to 3. Higher score represents greater reduction in food intake and 0 means unchanged.
Measured: Treatment for one/two week(s) and two weeks after stopping the medication
weight
Measured: Treatment for one/two week(s) and two weeks after stopping the medication
The meal time
Measured: Treatment for one/two week(s) and two weeks after stopping the medication
hemoglobin
Measured: Treatment for two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start26 Jun 2019
- Primary completion10 May 2020
- Study completion23 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030116
- Sponsor's protocol ID
- SQXS20181221
- Status last verified
- Aug 2021
- First submitted
- 30 Aug 2021
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Shenqu Xiaoshi Oral Liquid and Domperidone Suspension in the Treatment of Functional Dyspepsia in Children: a Randomized, Double-blind, Double-simulated, Multi-center Clinical Study
- ClinicalTrials.gov ID
- NCT05030116
- Acronym / sponsor ID
- SQXS20181221
- Conditions
- Dyspepsia
- Keywords
- functional dyspepsia, children, Traditional Chinese Medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 23 May 2020 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With domperidone suspension as the control, the effect of shenqu xiaoshi oral liquid on functional dyspepsia in children was evaluated objectively through multi-center, randomized, double-blind and double-simulation experiment, which alleviated the clinical symptoms, restored and promoted the normal growth and development of children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Shenqu Xiaoshi oral liquid |
| Control Group | Active comparator | Drug: Domperidone suspension |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 3-14 years, regardless of gender;
- Meet 1 or more conditions: (1) full after dinner; (2) early full; (3) abdominal pain, and defecation has nothing to do; After appropriate evaluation, symptoms cannot be fully explained by other diseases; Or have other symptoms of dyspepsia, but not caused by other diseases;
- Have symptoms at least 2 months before diagnosis and at least 4 days per month;
- During the 2-week leading-in period, no drugs were used to treat infantile anorexia and functional dyspepsia, and good eating habits were established. The patients were fed on time and still had the above-mentioned symptoms of anorexia and functional dyspepsia; The symptom score was 3.
- The legal guardian of the child should sign the informed consent form. If the child is 10 years old or older, they should sign the informed consent form and agree to participate in the study.
Key exclusion criteria (6 listed)
- Anorexia and dyspepsia caused by anorexia or dyspepsia caused by the influence of certain drugs or other confirmed diseases, such as erosive gastritis and gastric ulcer;
- Children with severe malnutrition;
- Children with abnormal ecg, liver and kidney functions, nervous system, respiratory system and endocrine system considered by the investigator;
- Children with mental disorders, dementia and unclear speech;
- Lactose intolerance or allergy to drug ingredients, or allergy to traditional Chinese medicine;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shenqu Xiaoshi oral liquidShenqu Xiaoshi oral liquid | Drug | Experimental group |
| Domperidone suspensionDomperidone suspension | Drug | Control Group |
Primary outcome
Total effective rate
Time frame: Treatment for two weeks
6 secondary outcomes
Clinical symptom scores
Time frame: Treatment for one/two week(s)
Total effective rate
Time frame: Two weeks after stopping the medication
Food intake
Time frame: Treatment for one/two week(s) and two weeks after stopping the medication
weight
Time frame: Treatment for one/two week(s) and two weeks after stopping the medication
The meal time
Time frame: Treatment for one/two week(s) and two weeks after stopping the medication
hemoglobin
Time frame: Treatment for two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Dyspepsia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Shenqu Xiaoshi oral liquid and Domperidone suspension in people with Dyspepsia, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total effective rate (time frame: Treatment for two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.