Traditional Chinese Medicine Xiang-sha-liu-jun Granules in Patients With Postprandial Distress Syndrome(PDS)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Postprandial Distress Syndrome

Intervention / Treatment
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* Drug: placebo
* Drug: Xiang-sha-liu-jun granules


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>Participants will orally take the placebo granules 12g twice a day for 4 weeks. No other interventions during the study period will be allowed. | Drug: placebo<br> <br> |
| Active Comparator: Xiang-sha-liu-jun granules<br>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. | Drug: Xiang-sha-liu-jun granules<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 is related with several hormones such as CCK and ghrelin. | gastric emptying will be assessed at baseline and 4 weeks during oral administration of medicine |