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

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 Overview

• Status: Unknown
• Conditions: Postprandial Distress Syndrome
• Intervention / Treatment: Drug: placebo; Drug: Xiang-sha-liu-jun granules

• Study Type: Interventional
• Enrollment (Anticipated): 216
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510405
      • Recruiting
      • the first hospital affiliated to Guangzhou university of Chinese medicine
      • Contact: suiping huang, Ph.D
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Wuhan integrated TCM and western medicine hospital
      • Contact: zhaohong Shi, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Drug: placebo
Active Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Collaborators: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine; Wuhan Integrated TCM and Western Medicine Hospita
• Investigators: Study Chair: xudong Tang, Ph.D, xi yuan hospital

Publications and helpful links

General Publications

• Zhang J, Wang X, Shi X, Xie J, Zhang M, Ma J, Wang F, Tang X. Combination of 15 lipid metabolites and motilin to diagnose spleen-deficiency FD. Chin Med. 2019 Apr 15;14:16. doi: 10.1186/s13020-019-0238-9. eCollection 2019.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: April 27, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 4, 2016

Study Record Updates

• Last Update Posted (Estimate): May 5, 2016
• Last Update Submitted That Met QC Criteria: May 4, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: Digestion-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES