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

Postprandial Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02762136
• Other study ID #: Digestion-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: April 27, 2016
• Last updated: May 4, 2016
• Start date: August 2015
• Est. completion date: April 2018

Study information

• Verified date: April 2016
• Source: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Contact: xudong Tang, Ph.D
• Phone: +86-10-62835001
• Email: txdly[@]sina.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: April 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postprandial Distress Syndrome
• Syndrome

Intervention

Drug:
• placebo

• 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

Locations

Country	Name	City	State
China	the first hospital affiliated to Guangzhou university of Chinese medicine	Guangzhou	Guangdong
China	Wuhan integrated TCM and western medicine hospital	Wuhan	Hubei

Sponsors (3)

Lead Sponsor	Collaborator
Xiyuan Hospital of China Academy of Chinese Medical Sciences	The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, Wuhan Integrated TCM and Western Medicine Hospita

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of postprandial discomfort severity Scale		Postprandial Discomfort Severity Scale at baseline, 2 weeks, and 4 weeks during oral administration of medicine	Yes
Secondary	global impression scale		global impression scale at baseline, 2 weeks, and 4 weeks during oral administration of medicine	Yes
Secondary	SF-36 questionnaire		SF-36 questionnaire at baseline, 2 weeks, and 4 weeks during oral administration of medicine	Yes
Secondary	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	Yes