Clinical trial NCT02762136: Traditional Chinese Medicine Xiang-sha-liu-jun Granules in Patients With Postprandial Distress Syndrome(PDS)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Postprandial Distress Syndrome
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
name: Wuhan Integrated TCM and Western Medicine Hospita
First posted: 2016-05-04
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: change of postprandial discomfort severity Scale
timeFrame: Postprandial Discomfort Severity Scale at baseline, 2 weeks, and 4 weeks during oral administration of medicine
Secondary outcomes:
measure: global impression scale
timeFrame: global impression scale at baseline, 2 weeks, and 4 weeks during oral administration of medicine
measure: SF-36 questionnaire
timeFrame: SF-36 questionnaire at baseline, 2 weeks, and 4 weeks during oral administration of medicine
measure: gastric emptying
timeFrame: gastric emptying will be assessed at baseline and 4 weeks during oral administration of medicine
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the first hospital affiliated to Guangzhou university of Chinese medicine
state: Guangdong
city: Wuhan
country: China
facility: Wuhan integrated TCM and western medicine hospital
state: Hubei
Study officials:
affiliation: xi yuan hospital
name: xudong Tang, Ph.D
role: STUDY_CHAIR
References:
citation: 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.