Traditional Chinese Medicine Xiang-sha-liu-jun Granules in Patients With Postprandial Distress Syndrome(PDS)
Phase 1
- Conditions
- Postprandial Distress Syndrome
- Interventions
- Drug: placeboDrug: Xiang-sha-liu-jun granules
- Registration Number
- NCT02762136
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 216
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo Participants 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 Xiang-sha-liu-jun granules 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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
Trial Locations
- Locations (2)
Wuhan integrated TCM and western medicine hospital
🇨🇳Wuhan, Hubei, China
the first hospital affiliated to Guangzhou university of Chinese medicine
🇨🇳Guangzhou, Guangdong, China