Traditional Chinese Medicine Xiang-sha-liu-jun Granules in Patients With Postprandial Distress Syndrome(PDS)
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
1 other identifier
interventional
216
1 country
2
Brief 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 previous studies, more convinced evidence of randomized placebo-controlled study is needed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2015
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 27, 2016
CompletedFirst Posted
Study publicly available on registry
May 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedMay 5, 2016
April 1, 2016
2.3 years
April 27, 2016
May 4, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
change of postprandial discomfort severity Scale
Postprandial Discomfort Severity Scale at baseline, 2 weeks, and 4 weeks during oral administration of medicine
Secondary Outcomes (3)
global impression scale
global impression scale at baseline, 2 weeks, and 4 weeks during oral administration of medicine
SF-36 questionnaire
SF-36 questionnaire at baseline, 2 weeks, and 4 weeks during oral administration of medicine
gastric emptying
gastric emptying will be assessed at baseline and 4 weeks during oral administration of medicine
Study Arms (2)
placebo
PLACEBO COMPARATORParticipants 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 COMPARATORParticipants will orally take the herbal formula granules 12g twice a day for 4 weeks. No other interventions during the study period will be allowed.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
the first hospital affiliated to Guangzhou university of Chinese medicine
Guangzhou, Guangdong, 510405, China
Wuhan integrated TCM and western medicine hospital
Wuhan, Hubei, 430022, China
Related Publications (1)
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.
PMID: 31011363DERIVED
Study Officials
- STUDY CHAIR
xudong Tang, Ph.D
xi yuan hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2016
First Posted
May 4, 2016
Study Start
August 1, 2015
Primary Completion
December 1, 2017
Study Completion
April 1, 2018
Last Updated
May 5, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will share