Postprandial Distress SyndromePhase 1/2NCT02762136
Traditional Chinese Medicine Xiang-sha-liu-jun Granules in Patients With Postprandial Distress Syndrome(PDS)
A Phase 1/2 study testing Xiang-sha-liu-jun granules in people with Postprandial Distress Syndrome, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 2 sites in China.
Trial summary
Functional dyspepsia (FD), which is one of the most common gastrointestinal disorders with high disease burden. Postprandial distress syndrome (PDS) is a common subtype of FD. Although the effectiveness of Chinese herbal formula of Xiang-sha-liu-jun granule (XSLJG) for alleviating PDS symptoms has been assessed in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postprandial Distress Syndrome
- What is being tested?
- Xiang-sha-liu-jun granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 2 sitesChina
- Study dates
- Aug 2015to Apr 2018
- 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
- i)Aging between 18 and 75 years, able to read and write Chinese;
- ii)have a TCM diagnosis of spleen deficiency and qi stagnation pattern;
- iii) Having normal esophagogastroduodenoscopy results within 6 months;
- iv) Having normal liver and renal function confirmed by blood tests within 3 months;
- v) Being diagnosed as PDS of FD by a specialist consultation;
- vi）Receiving no other treatments during the study;
- vii）Voluntarily agreeing with the study protocol and signing a written informed consent.
Who cannot join
- i)Having peptic ulcer or gastroesophageal reflux disease confirmed by esophagogastroduodenoscopy;
- ii) Having obvious signs of irritable bowel syndrome;
- iii) Having alarm symptoms (weight loss, black or tar stool, or dysphagia);
- iv) Having serious structural disease (disease of heart, lung, liver or kidney) or mental illness;
- v) Having had surgery related with the gastrointestinal tract, except for appendectomy more than six months ago;
- vi) Pregnant or breastfeeding;
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- vii) Being taking drugs which may affect the gastrointestinal tract; a minimum wash-out period of two weeks is required before participating in the trial;
- viii) Having a problem of malabsorption or maldigestion;
- ix) Having a history of allergies to the studied drugs and food;
- x) Having difficulties in attending the trial (such as paralysis, serious mental illness, dementia, renal diseases, stroke, coronary atherosclerotic heart diseases, diabetes or mental diseases, illiteracy);
- xi) Unwilling to sign the informed consent.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
the first hospital affiliated to Guangzhou university of Chinese medicine
Guangzhou, Guangdong, 510405
suiping huang, Ph.D
- Recruiting
Wuhan integrated TCM and western medicine hospital
Wuhan, Hubei, 430022
zhaohong Shi, Ph.D
About this study
Official title: Xiang-sha-liu-jun Granules as an Herbal Formula for the Treatment of Postprandial Distress Syndrome(PDS): a Prospective, Double-blinded, Randomized and Placebo-controlled,Three-center Trial
Functional dyspepsia (FD), which is one of the most common gastrointestinal disorders with high disease burden. Postprandial distress syndrome (PDS) is a common subtype of FD. Although the effectiveness of Chinese herbal formula of Xiang-sha-liu-jun granule (XSLJG) for alleviating PDS symptoms has been assessed in previous studies, more convinced evidence of randomized placebo-controlled study is needed.
- Conditions
- Postprandial Distress Syndrome
- Being tested
- placebo, Xiang-sha-liu-jun granules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Xiang-sha-liu-jun granulesDrug
The Xiang-sha-liu-jun granules comprises 10 herbs, Astragalus membranaceus (Huangqi) 15g, Codonopsis pilosula (Dangshen) 15 g, fructus aurantii (Zhiqiao) 15g, fructus amomi(Sharen) etc
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Participants will orally take the placebo granules 12g twice a day for 4 weeks. No other interventions during the study period will be allowed. Receives: Drug: placebo |
| Xiang-sha-liu-jun granules | Active comparator | Participants will orally take the herbal formula granules 12g twice a day for 4 weeks. No other interventions during the study period will be allowed. Receives: Drug: Xiang-sha-liu-jun granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of postprandial discomfort severity Scale
Measured: Postprandial Discomfort Severity Scale at baseline, 2 weeks, and 4 weeks during oral administration of medicine
Secondary outcomes (3)
global impression scale
Measured: global impression scale at baseline, 2 weeks, and 4 weeks during oral administration of medicine
SF-36 questionnaire
Measured: SF-36 questionnaire at baseline, 2 weeks, and 4 weeks during oral administration of medicine
gastric emptying
Gastric emptying is related with several hormones such as CCK and ghrelin.
Measured: gastric emptying will be assessed at baseline and 4 weeks during oral administration of medicine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startAug 2015
- Primary completionDec 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postprandial Distress SyndromeStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, Wuhan Integrated TCM and Western Medicine Hospita
- Responsible party
- Sponsor
- Investigators
- xudong Tang, Ph.D, Study chair, xi yuan hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762136
- Sponsor's protocol ID
- Digestion-01
- Status last verified
- Apr 2016
- First submitted
- 27 Apr 2016
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Zhang J, Wang X, Shi X, Xie J, Zhang M, Ma J, Wang F, Tang X. Combination of 15 lipid metabolites and motilin to diagnose spleen-deficiency FD. Chin Med. 2019 Apr 15;14:16. doi: 10.1186/s13020-019-0238-9. eCollection 2019.
PubMed 31011363
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xiang-sha-liu-jun Granules as an Herbal Formula for the Treatment of Postprandial Distress Syndrome(PDS): a Prospective, Double-blinded, Randomized and Placebo-controlled,Three-center Trial
- ClinicalTrials.gov ID
- NCT02762136
- Acronym / sponsor ID
- Digestion-01
- Conditions
- Postprandial Distress Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, Wuhan Integrated TCM and Western Medicine Hospita
- Study start
- Aug 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 4 May 2016 (estimated)
- 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.
Functional dyspepsia (FD), which is one of the most common gastrointestinal disorders with high disease burden. Postprandial distress syndrome (PDS) is a common subtype of FD. Although the effectiveness of Chinese herbal formula of Xiang-sha-liu-jun granule (XSLJG) for alleviating PDS symptoms has been assessed in previous studies, more convinced evidence of randomized placebo-controlled study is needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placeboParticipants will orally take the placebo granules 12g twice a day for 4 weeks. No other interventions during the study period will be allowed. |
| Xiang-sha-liu-jun granules | Active comparator | Drug: Xiang-sha-liu-jun granulesParticipants will orally take the herbal formula granules 12g twice a day for 4 weeks. No other interventions during the study period will be allowed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- i)Aging between 18 and 75 years, able to read and write Chinese;
- ii)have a TCM diagnosis of spleen deficiency and qi stagnation pattern;
- iii) Having normal esophagogastroduodenoscopy results within 6 months;
- iv) Having normal liver and renal function confirmed by blood tests within 3 months;
- v) Being diagnosed as PDS of FD by a specialist consultation;
Key exclusion criteria (11 listed)
- i)Having peptic ulcer or gastroesophageal reflux disease confirmed by esophagogastroduodenoscopy;
- ii) Having obvious signs of irritable bowel syndrome;
- iii) Having alarm symptoms (weight loss, black or tar stool, or dysphagia);
- iv) Having serious structural disease (disease of heart, lung, liver or kidney) or mental illness;
- v) Having had surgery related with the gastrointestinal tract, except for appendectomy more than six months ago;
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 |
|---|---|---|
| placebo | Drug | placebo |
| Xiang-sha-liu-jun granulesThe Xiang-sha-liu-jun granules comprises 10 herbs, Astragalus membranaceus (Huangqi) 15g, Codonopsis pilosula (Dangshen) 15 g, fructus aurantii (Zhiqiao) 15g, fructus amomi(Sharen) etc | Drug | Xiang-sha-liu-jun granules |
Primary outcome
change of postprandial discomfort severity Scale
Time frame: Postprandial Discomfort Severity Scale at baseline, 2 weeks, and 4 weeks during oral administration of medicine
3 secondary outcomes
global impression scale
Time frame: global impression scale at baseline, 2 weeks, and 4 weeks during oral administration of medicine
SF-36 questionnaire
Time frame: SF-36 questionnaire at baseline, 2 weeks, and 4 weeks during oral administration of medicine
gastric emptying
Time frame: gastric emptying will be assessed at baseline and 4 weeks during oral administration of medicine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Derived from this study: PubMed 31011363Zhang J, Wang X, Shi X, Xie J, Zhang M, Ma J, Wang F, Tang X. Combination of 15 lipid metabolites and motilin to diagnose spleen-deficiency FD. Chin Med. 2019 Apr 15;14:16. doi: 10.1186/s13020-019-0238-9. eCollection 2019.
- Individual participant dataSharing planned: Yes
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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.
xudong Tang, Ph.D study chair
xi yuan hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Xiang-sha-liu-jun granules in people with Postprandial Distress Syndrome, 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 7 inclusion and 11 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 5 May 2016. 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. Some participants in this study may receive a placebo. 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 xudong Tang, Ph.D (+86-10-62835001, txdly@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of postprandial discomfort severity Scale (time frame: Postprandial Discomfort Severity Scale at baseline, 2 weeks, and 4 weeks during oral administration of medicine). 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 NCT02762136, 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 5 May 2016.