Trial | NCT02762136  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    216
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.
Study Started
Aug 31
2015
Primary Completion
Dec 31
2017
Anticipated
Study Completion
Apr 30
2018
Anticipated
Last Update
May 05
2016
Estimate

Drug placebo

Drug Xiang-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

placebo Placebo Comparator

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 Active Comparator

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.

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.
No Results Posted