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

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Postprandial Distress Syndrome

Treatments: Drug: Xiang-sha-liu-jun granules; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02762136

Digestion-01

Details and patient eligibility

About

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.

Enrollment: 216 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

Participants will orally take the placebo granules 12g twice a day for 4 weeks. No other interventions during the study period will be allowed.

Treatment:

Drug: placebo

Xiang-sha-liu-jun granules

Active Comparator group

Description:

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.

Treatment:

Drug: Xiang-sha-liu-jun granules