Traditional Chinese Medicine for Treatment of Irritable Bowel Syndrome

NCT03135821 | Unknown Phase 2 DMC

• 1 other identifier: SGH-TCM-GASTR-TCMIBS
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Change from baseline in IBS-Symptom Severity Score at 8 weeks

  Improvement in IBS-Symptom Severity Score

  8 weeks

Study Arms (2)

10% active Placebo

PLACEBO COMPARATOR

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

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

ACTIVE COMPARATOR

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

Interventions

TCM DIAGNOSTIC_TEST

10% active Placebo; Traditional Chinese Medication (TCM) Drug A,B,C,D

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead
• Singapore College of Traditional Chinese Medicine: collaborator
• Duke-NUS Graduate Medical School: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

RECRUITING

Related Publications (10)

• Drossman DA, Dumitrascu DL. Rome III: New standard for functional gastrointestinal disorders. J Gastrointestin Liver Dis. 2006 Sep;15(3):237-41.

  PMID: 17013448 RESULT

• Li Q, Yang GY, Liu JP. Syndrome differentiation in chinese herbal medicine for irritable bowel syndrome: a literature review of randomized trials. Evid Based Complement Alternat Med. 2013;2013:232147. doi: 10.1155/2013/232147. Epub 2013 Mar 11.

  PMID: 23554827 RESULT

• Gwee KA, Bak YT, Ghoshal UC, Gonlachanvit S, Lee OY, Fock KM, Chua AS, Lu CL, Goh KL, Kositchaiwat C, Makharia G, Park HJ, Chang FY, Fukudo S, Choi MG, Bhatia S, Ke M, Hou X, Hongo M; Asian Neurogastroenterology and Motility Association. Asian consensus on irritable bowel syndrome. J Gastroenterol Hepatol. 2010 Jul;25(7):1189-205. doi: 10.1111/j.1440-1746.2010.06353.x.

  PMID: 20594245 RESULT

• Saad RJ, Hasler WL. A technical review and clinical assessment of the wireless motility capsule. Gastroenterol Hepatol (N Y). 2011 Dec;7(12):795-804.

  PMID: 22347818 RESULT

• Cardol M, de Haan RJ, de Jong BA, van den Bos GA, de Groot IJ. Psychometric properties of the Impact on Participation and Autonomy Questionnaire. Arch Phys Med Rehabil. 2001 Feb;82(2):210-6. doi: 10.1053/apmr.2001.18218.

  PMID: 11239312 RESULT

• Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997 Apr;11(2):395-402. doi: 10.1046/j.1365-2036.1997.142318000.x.

  PMID: 9146781 RESULT

• Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.

  PMID: 11491192 RESULT

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 RESULT

• Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. doi: 10.1097/00006842-200203000-00008.

  PMID: 11914441 RESULT

• Sisson G, Ayis S, Sherwood RA, Bjarnason I. Randomised clinical trial: A liquid multi-strain probiotic vs. placebo in the irritable bowel syndrome--a 12 week double-blind study. Aliment Pharmacol Ther. 2014 Jul;40(1):51-62. doi: 10.1111/apt.12787. Epub 2014 May 11.

  PMID: 24815298 RESULT

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Yu Tien Wang

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huifang Tan

CONTACT

82237309; tan.hui.fang@sgh.com.sg

Chengyi Lee

CONTACT

91391717

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Placebo vs Traditional Chinese Medication (TCM) Drug A,B,C,D

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: May 1, 2017
• Study Start: March 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: May 1, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)