Postprandial Distress Syndrome
Conditions
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.
Interventions
DRUGplacebo
DRUGXiang-sha-liu-jun granules
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
Sponsors
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Wuhan Integrated TCM and Western Medicine Hospita
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change of postprandial discomfort severity Scale | Postprandial Discomfort Severity Scale at baseline, 2 weeks, and 4 weeks during oral administration of medicine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Gastric emptying is related with several hormones such as CCK and ghrelin. |
Countries
China
Contacts
Primary Contactxudong Tang, Ph.D
Backup Contactfengyun Wang, Ph.D
Outcome results
None listed