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Non-erosive Reflux DiseasePhase 1/2NCT02892357

Efficacy of Traditional Chinese Medicine Combined With Omeprazole in Patients With Non-erosive Reflux Disease

A Phase 1/2 study testing Treatment group in people with Non-erosive Reflux Disease, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a double-blind,randomised,placebo-controlled clinical trial.We would like to investigate the safety and efficacy of Jianpi Qinghua granule(a Chinese herbal compound) combined with half-dose omeprazole in treatment of non-erosive reflux disease(NERD). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-erosive Reflux Disease
What is being tested?
Treatment group
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
204 participants
Where
2 sitesChina
Study dates
Jan 2017to Dec 2019
Phase
Phase 1/2
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aging between 18 and 75 years, able to read and write Chinese;
  • Meet the criteria of diagnosis of NERD
  • GERD Q score>=8
  • Meet the TCM diagnosis of syndrome of dampness-heat due to spleen deficiency
  • Receiving no other treatments during the study;
  • Voluntarily agreeing with the study protocol and signing a written informed consent.

Who cannot join

  • Gastro-duodenal ulcer
  • Infections, inflammations, or obstruction of the small or large intestine
  • History of gastrointestinal cancer, or prior surgery of the stomach or intestine
  • Females who are pregnant or those lacking adequate contraception
  • Unwilling to sign the informed consent

Trial locations and contacts

2 sites in 1 country.

fengyun Wang, Ph.D contact

+86-10-62835001

wfy811@163.com

China2 sites, 2 recruiting

  • Dongfang Hospital

    Beijing, Beijing Municipality, 100000

    Chang Zhang

    Recruiting

  • Guanganmen Hospital

    Beijing, Beijing Municipality, 100000

    Bing Zhou

    Recruiting

Other trials in China

About this study

Official title: Efficacy of Traditional Chinese Medicine Jianpi Qinghua Granule Combined With Low Dose Omeprazole in Patients With Non-erosive Reflux Disease (NERD)

This is a double-blind,randomised,placebo-controlled clinical trial.We would like to investigate the safety and efficacy of Jianpi Qinghua granule(a Chinese herbal compound) combined with half-dose omeprazole in treatment of non-erosive reflux disease(NERD).

Read the detailed description

This is a double-blind,randomised,placebo-controlled clinical trial.We recruit patients that suffer from non-erosive reflux disease and then divide them into two groups:treatment group and control group.Treatment group take Jianpi Qinghua granule and half-dose omeprazole for 4 weeks,control group take a normal dose of omeprazole for 4 weeks.Finally we investigate the safety of Jianpi Qinghua granule combined with half-dose omeprazole in treatment of non-erosive reflux disease(NERD),and contrast the efficacy of Jianpi Qinghua granule with omeprazole.

Being tested
Treatment group, Control group
Medical subject headings
Non-Erosive Reflux Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment groupDrug

    Also called Experimental group

    Jianpi Qinghua granules:twice a day,1 bag a time;10mg omeprazole and 10mg sham ,once a day,all for 4 weeks.

  • Control groupDrug

    Also called Omeprazole group

    sham Jianpi Qinghua granules:twice a day,1 bag a time; 20mg omeprazole once a day ,all for 4 weeks.

Study groups in NCT02892357
Study groupRoleWhat they receive
Treatment groupExperimentalParticipants in this group take the herbal compound of Jianpi Qinghua granules and half-dose omeprazole tablet.Jianpi Qinghua granule:one bag after 1 hour of breakfast and supper(twice a day) for 4 weeks.Half-dose omeprazole tablet:1 tablet of real omeprazole (10mg) and 1 tablet of Sham(10mg),once a day before breakfast for 4 weeks.
Receives: Drug: Treatment group
Control groupActive comparatorParticipants in this group take the sham herbal granules twice a day as treatment group and two pieces of real omeprazole tablet(10mg each) once a day before breakfast for 4 weeks.
Receives: Drug: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of GERD Q Scale

    GerdQ was developed through the integration of validated questionnaires reflecting psychological problems and the data of diagnoses of GERD in primary and secondary medical institutions. GerdQ is used for the diagnosis and management of GERD with good authenticity and reliability. GerdQ has six items: heartburn, regurgitation, abdominal pain, nausea, sleep disorders and use of OTC medications. The score is evaluated according to the frequency of every item occurred in recent one week. 0 day, 1 day, 2-3 days, 4-7days respectively assessed to the score of 0, 1, 2 and 3 in the items of heartburn, regurgitation, sleep disorders and use of OTC medications. 0 day, 1 day, 2-3 days, 4-7days respectively assessed to the score of 3, 2, 1 and 0 in the items of abdominal pain and nausea.

    Measured: 6 weeks

Secondary outcomes (5)

  1. Change of TCM Syndrome Questionnaire

    The scale is based on the Clinical Guideline of New Drugs for Traditional Chinese Medicine. It is uesd to evaluate the discomfort of gastrointestinal system based on TCM theory. It contains 15 items of TCM terminology which used to assess severity of physical discomfort (0 = absent; 1 = mild; 2 = moderate; 3 = severe). The main concerns of these items include stomach distension, stomachache, appetite decrease, heartburn, acid regurgitation, sputum increase, feeling of obstruction in pharynx, feeling thirsty but not want water, feeling of distention on both sides of the lower abdomen, limbs weakness, short of breath, feeling weak and unwilling to speak, somatosensory heaviness, feeling afraid of the cold and having loose stool.

    Measured: 6 weeks

  2. Change of 36-Item Short Form Survey Instrument(SF-36)

    SF-36 reflects healthy condition.

    Measured: 6 weeks

  3. Change of Patients Report Clinical Outcomes(PRO)

    The PRO was developed by the digestive department of Xiyuan hospital. Considering the clinical characteristics of patients with chronic gastrointestinal diseases in China, we have spended two years to collect measurement indicators, screen and optimizing items, implement pre-survey of small samples and field survey, and finally formulated this current PRO. It contains 35 items in six dimensions (regurgitation, dyspepsia, physical status, ability to life, defecation situation and mental state). Our analysis of 274 questionnaires show that the PRO has good reliability and validity in reflecting the situation of chronic gastrointestinal diseases. Every item in PRO has five levels of discomfort(never, occasionally, sometimes, often, always) and they respectively represent the score of 0, 1, 2, 3 and 4.

    Measured: 6 weeks

  4. Change of the Hamilton Depression Scale 17 item (HAMD17)

    The scoring criteria of the scale were :(0)none;(1)mild;(2)moderate;(3)severe;(4) extremely heavy.A few items use the 3-grade scoring method with 0-2 points, and the grading standard is :(0) none;(1) mild to moderate;(2) severely.

    Measured: 6 weeks

  5. Safety outcomes

    Safty indexs contain adverse event, general medical examination, blood biochemical examination, urine and stool routine test and electrocardiography.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionSep 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
204 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02892357
Sponsor's protocol ID
Digestion-04
Status last verified
Feb 2019
First submitted
2 Sep 2016
Last updated
26 Aug 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Zhang J, Che H, Zhang B, Zhang C, Zhou B, Ji H, Xie J, Shi X, Li X, Wang F, Tang X. JianpiQinghua granule reduced PPI dosage in patients with nonerosive reflux disease: A multicenter, randomized, double-blind, double-dummy, noninferiority study. Phytomedicine. 2021 Jul 15;88:153584. doi: 10.1016/j.phymed.2021.153584. Epub 2021 May 3.

    PubMed 34119741

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Treatment group in people with Non-erosive Reflux Disease, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 2 sites 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact fengyun Wang, Ph.D (+86-10-62835001, wfy811@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of GERD Q Scale (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02892357, which also lists 1 linked publication.

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 26 Aug 2019.

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