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Trial record 16 of 43 for:    herbal medicine AND Chinese | Recruiting, Not yet recruiting, Available Studies

Traditional Chinese Medicine for Treatment of Irritable Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT03135821
Recruitment Status : Recruiting
First Posted : May 1, 2017
Last Update Posted : May 1, 2017
Sponsor:
Collaborators:
Singapore College of Traditional Chinese Medicine
Duke-NUS Graduate Medical School
Information provided by (Responsible Party):
Singapore General Hospital

Brief Summary:
Irritable bowel syndrome (IBS) is a prevalent condition that adversely affects patient's quality of life and represents a large health care burden globally. Currently, there is no satisfactory treatment for IBS and Chinese Herbal medicine (CHM) has been suggested to be potentially useful. However, the efficacy of CHM in the treatment of IBS is unclear and its mechanism of action is unknown. To date, attempts to characterize CHM efficacy universally suffer from poor scientific method or they do not faithfully replicate authentic CHM best practice. The overall goal of this proposal is hence to address these deficiencies by combining the best of CHM with western medicine.The investigators propose a 10-week randomized, double-blind, placebo-controlled study on 104 patients that form the intersect between western medicine and CHM. The participants would fulfill ROME III criteria for IBS-Constipation predominant subtype, which is also the TCM (Traditional Chinese Medicine) syndrome of Liver Qi stagnation. The investigators will test a core herbal formula specific for treatment of Liver Qi stagnation against placebo that consist of only 10% active ingredients but which is indistinguishable by taste from active treatment. Efficacy will be assessed by comparing symptoms reported at baseline (2-week run-in period) to end of treatment (8 weeks) and an optional follow up period (12 weeks). The primary end point will be improvement in IBS-Symptom Severity Score. Mechanism of action will be explored by measuring changes to the stool microbiome and GI transit times. If successful, this trial would provide one of the first evidence- and mechanism-based approach to translate CHM into mainstream IBS management.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Diagnostic Test: TCM Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Placebo vs Traditional Chinese Medication (TCM) Drug A,B,C,D
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Placebo Controlled Trial of Traditional Chinese Medicine for Treatment of Irritable Bowel Syndrome
Study Start Date : March 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Arm Intervention/treatment
Placebo Comparator: 10% active Placebo

Placebo will constitute granules with 10% active core ingredients as below:

White Peony Root 10g Processed Liquorice 3g Immature Bitter Orange 8g White Atractylodes Rhizome 15g

- 2 packets of sachets once before breakfast and once before dinner.

Diagnostic Test: TCM
Active Comparator: Traditional Chinese Medication (TCM) Drug A,B,C,D

Traditional Chinese Medication (TCM) Drug A,B,C,D.

TCM Drug A:

White Peony Root 10g Processed Liquorice 3g Immature Bitter Orange 8g White Atractylodes Rhizome15g

TCM Drug B:

White Peony Root 10g Processed Liquorice 3g Immature Bitter Orange 8g White Atractylodes Rhizome 15g Liver stagnation with heaty transformation: add Scutellaria Root 5g、Prunella Spike 5g

TCM Drug C:

White Peony Root 10g Processed Liquorice 3g Immature Bitter Orange 8g White Atractylodes Rhizome 15g Prominent abdominal pain: White Peony Root to increase to 15g add Bupleurum Root 5g

TCM Drug D:

White Peony Root 10g Processed Liquorice 3g Immature Bitter Orange 8g White Atractylodes Rhizome 15g Hard stools: add Peach Kernel 5g、Areca Seed 5g

Diagnostic Test: TCM



Primary Outcome Measures :
  1. Change from baseline in IBS-Symptom Severity Score at 8 weeks [ Time Frame: 8 weeks ]
    Improvement in IBS-Symptom Severity Score



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ethnic group: Chinese only
  • Presence of FGID as determined by managing physician and fulfil ROME III criteria for IBS-C
  • To be eligible for randomization, patients will need to report during the baseline period:

    o IBS-symptom severity score (SSS) of ≥150

  • Physical examination without clinically relevant abnormalities
  • Completed a relevant colonic imaging (e.g. colonoscopy, barium enema, or other colonic imaging) within 60 months before enrolment that shows absence of structural abnormality which could account for the patient's symptom as determined by the managing physician

    o Patients below the age of 45 without colonic imaging must have stable IBS-C symptoms for at least 5 years (without evidence of rectal bleeding, weight loss, recent changes in bowel habits, family history of colorectal cancer or anaemia)

  • Completed blood test

    • Haemoglobin within range of 11-17g/dL (for females), and 13-19g/dL (for males) Abnormal haemoglobin which is accounted for by a non-GI-related condition (e.g. thalassemia), as determined by managing physician, is allowed
    • Blood tests taken 3 months or longer before enrolment are considered invalid
  • Completed 12-Lead ECG

    • No clinically relevant abnormalities in 12-lead ECG performed for this study and in laboratory findings
    • 12-Lead ECG taken 3 months or longer before enrolment are considered invalid
  • Oral contraceptives are allowed provided that they have not been changed in the previous 6 months before the start of the run-in period
  • The patient has the ability to provide informed consent
  • Patient is willing to be compliant with study procedures including, and will be contactable by phone for weekly IBS treatment and symptoms
  • Mentally competent, able to give written informed consent prior to any study-related procedure and compliant to undergo all visits and procedures scheduled in the study.

Exclusion Criteria:

  • BMI <16 or >35 A history of surgery to remove a segment of the gastrointestinal tract or bariatric surgery for obesity at any time; appendectomy/cholecystectomy within 2 months or other abdominal surgeries within 6 months before entry into the trial; history of diverticulitis or any chronic condition that could be associated with abdominal pain or discomfort and could confound the assessments in this trial; or a history of laxative abuse. Investigations for exclusion of structural abnormality will be performed as per regional guideline (19).
  • Failure to discontinue medication prior to study, specifically:

    • antibiotics and probiotic consumption within the last 1 month
    • CHM medications within the last 2 weeks
  • All medications except bisacodyl (rescue medication) which may alter GI motility will also have to be stopped during the 2 weeks run-in period.

    o Patients are allowed to take rescue medication if in need, when abdominal pain or distension ≥70 on irritable bowel syndrome severity scoring system

  • Pregnancy or breastfeeding
  • Hypersensitivity to the drug excipients.
  • Patient is not able to understand or collaborate throughout the study.
  • Not currently or in the preceding 4 weeks enrolled in a clinical study with another investigational drug.
  • Patient has any condition that, in the opinion of the Investigator that would compromise the well-being of the patient or the requirements of the study.
  • Presence of ischaemic heart disease, diabetes mellitus, thyroid dysfunction or renal impairment (as determined by study investigators) or previous surgery or anatomical anomalies which may alter GI motility (as assessed by investigators)
  • Failure to maintain usual diet, lifestyle and exercise regimen throughout the study.
  • Patients with major psychiatric or neurological disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03135821


Contacts
Contact: Huifang Tan 82237309 ext 65 tan.hui.fang@sgh.com.sg
Contact: Chengyi Lee 91391717 ext 65

Locations
Singapore
Singapore General Hospital Recruiting
Singapore, Singapore
Contact: Yu Tien Wang         
Sponsors and Collaborators
Singapore General Hospital
Singapore College of Traditional Chinese Medicine
Duke-NUS Graduate Medical School
Investigators
Principal Investigator: Yu Tien Wang Singapore General Hospital

Publications of Results:

Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT03135821     History of Changes
Other Study ID Numbers: SGH-TCM-GASTR-TCMIBS
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases