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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-04-30

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.

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Detailed Description

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Conditions

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Postprandial Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Xiang-sha-liu-jun granules

Intervention Type DRUG

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

Interventions

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placebo

Intervention Type 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

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No