Efficacy and Safety of Hou Gu Mi Xi in Patients With Spleen Qi Deficiency and Non-organic Gastrointestinal Disorders

NCT03019042 | Completed DMC

• 1 other identifier: JXUTCM-EBM-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This trial aims to determine whether Hou Gu Mi Xi is an effective treatment for improving symptoms and indicators in patients with spleen qi deficiency and mild gastrointestinal disorder.

Conditions

Gastrointestinal Disease

Keywords

Hou Gu Mi Xi; Shen Ling Bai Zhu San; mild gastrointestinal disorders; traditional Chinese medicine; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Change from baseline in total scores of Spleen Qi Deficiency Symptoms Grading and Quantifying Scale (Units on a scale)

  Higher score indicates severer symptoms of Spleen Qi Deficiency. Units of measure (Units on a scale)

  At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks

Secondary Outcomes (8)

• Change from baseline in Gastrin-17 (ng/L)

  At baseline and 52 and 104 weeks

• Quantitative results of gastroscopy

  At baseline and 104 weeks

• Changes from baseline in body weight (kg)

  At baseline and 52 and 104 weeks

• Changes from baseline in body mass index (kg/m2)

  At baseline and 52 and 104 weeks

• Incidence of any adverse events

  From the first dose of intervention up to 104 weeks

Study Arms (2)

Hou Gu Mi Xi

EXPERIMENTAL

Patients in this arm receive Hou Gu Mi Xi, with oral dose of 30 g/day (contain 10.1 herb materials) during entire follow up period (2 years). HGMX is composed of 10 dietary Chinese herbs (including ginseng (Renshen), tuckahoe (Fuling), coixenolide (Yiyiren), Chinese yam (Shanyao), lotus seed (Lianzi), amomum (Sharen), platycodon (Jiegen), white hyacinth bean (Baibiandou), licorice (Gancao), and orange peel (Jupi)), early rice, and oats.

Dietary Supplement: Hou Gu Mi Xi

placebo

PLACEBO COMPARATOR

Patients in this arm receive placebo, with oral dose of 30 g/day during entire follow up period (2 years). The placebo is only consist of early rice and oats.

Other: placebo

Interventions

Hou Gu Mi Xi DIETARY_SUPPLEMENT

Hou Gu Mi Xi is a dietary therapy form of Shen Ling Bai Zhu San, of which removes atractylodes and platycodon grandiflorum, adds perilla leaf for adapting a dietary therapy.

Hou Gu Mi Xi

placebo OTHER

The placebo has same appearance, taste and smell as Hou Gu Mi Xi.

placebo

Eligibility Criteria

• Age: 14 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patient should be status of spleen qi deficiency, that is, meet 2 main symptoms of spleen deficiency and 2 main symptoms of qi deficiency, or have 2 main symptoms of spleen deficiency, 1 main symptoms of qi deficiency and 1 tongue symptom, or have 1 main symptom of spleen deficiency + 1 main symptom of qi deficiency + 2 secondary symptom + 1 tongue symptom as follow:
• Main symptoms of spleen deficiency: a) poor appetite; b) abnormal stool (loose, diarrhea); c) abdominal distention after meal or afternoon
• Main symptoms of qi deficiency: a) fatigue; b) tired mind and taciturnity
• Secondary symptoms: a) tastelessness, hypodipsia, like hot drink, or polysialia; b) abdominal pain, as a result either patients like warm or press, or remit after meal, or occur when work; c) nausea and vomiting; d) fullness in stomach; e) abnormal bowel sounds; f) lean or puffiness; g) sallow complexion; h) powerless defecation weakness; i) edema
• Tongue symptoms: pale or swollen or teeth-printed tongue with thin and white fur
• Fourteen years old or more
• Sign the informed consent
• Patients who have organic pathologic changes, including peptic ulcer, gastrointestinal erosions, gastroesophageal reflux disease, acute gastrointestinal hemorrhage or perforation, structural changes in gastrointestinal structure, gastrointestinal vascular diseases, ileus, and benign tumor
• Pregnancy or breast-feeding women
• Allergic to sample or sample composition
• impaired liver function, including one of following condition: a) total bilirubin \> 2 upper limit of normal (ULN); b) alanine transaminase \>2 ULN; or c) aspartate aminotransferase \>2 ULN
• impaired kidney function, that is, serum creatinine \>2 ULN
• obviously abnormal electrocardiogram
• patients who undertaken drugs that could cause damage in stomach and intestine, or patients experience side effects of dyspepsia as undertaking non-steroidal anti-inflammatory drugs, theophylline, oral antibiotic or potassium supplements within 3 months
• patients who are receiving any agents or other intervention for treating his/her gastrointestinal disorder

Sponsors & Collaborators

• Jiangxi University of Traditional Chinese Medicine: lead
• Nanchang Hongdu Hospital of Traditional Chinese Medicine: collaborator
• Nanchang Hospital of Integrated Traditional Chinese and Western Medicine: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine: collaborator

Study Sites (1)

Jiangxi University of Traditional Chinese Medicine

Nanchang, Jiangxi, 330004, China

Location

Related Publications (6)

• Everhart JE, Ruhl CE. Burden of digestive diseases in the United States part I: overall and upper gastrointestinal diseases. Gastroenterology. 2009 Feb;136(2):376-86. doi: 10.1053/j.gastro.2008.12.015. Epub 2009 Jan 3. No abstract available.

  PMID: 19124023 BACKGROUND

• Farthing M, Roberts SE, Samuel DG, Williams JG, Thorne K, Morrison-Rees S, John A, Akbari A, Williams JC. Survey of digestive health across Europe: Final report. Part 1: The burden of gastrointestinal diseases and the organisation and delivery of gastroenterology services across Europe. United European Gastroenterol J. 2014 Dec;2(6):539-43. doi: 10.1177/2050640614554154. No abstract available.

  PMID: 25452850 BACKGROUND

• Wu TH, Chen IC, Chen LC. Antacid effects of Chinese herbal prescriptions assessed by a modified artificial stomach model. World J Gastroenterol. 2010 Sep 21;16(35):4455-9. doi: 10.3748/wjg.v16.i35.4455.

  PMID: 20845514 BACKGROUND

• Yin GY, Chen Y, Shen XJ, He XF, Zhang WN. Study on the pathophysiologic basis of classification of 'spleen' deficiency in chronic gastritis. Chin Med J (Engl). 2005 Mar 20;118(6):468-73.

  PMID: 15788127 BACKGROUND

• Yin GY, Zhang WN, Shen XJ, He XF, Chen Y. Study on the pathological basis of classification of spleen deficiency in chronic gastritis. Chin Med J (Engl). 2004 Aug;117(8):1246-52.

  PMID: 15361303 BACKGROUND

• Chen X, Nie H, Liu W, Zhou X, Nie J, Xie B, Chen D, Jiang Y, Zhang K, Fu Y, Yang D, Xiong Y, Zhao Z, Sun X, Zhu W. Efficacy and Safety of Hou Gu Mi Xi on Spleen Qi Deficiency in Patients with Nonorganic Gastrointestinal Disorders: Protocol for a Multicenter, Randomized, Placebo-Controlled Trial. Evid Based Complement Alternat Med. 2018 Dec 2;2018:1980491. doi: 10.1155/2018/1980491. eCollection 2018.

  PMID: 30622590 DERIVED

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Weifeng Zhu, Ph.D.

  Jiangxi University of Traditional Chinese Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 7, 2017
• First Posted: January 12, 2017
• Study Start: November 15, 2016
• Primary Completion: July 10, 2018
• Study Completion: July 10, 2019
• Last Updated: May 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)