NCT04296500

Brief Summary

This study aimed to identify inflammatory bowel disease (IBD) patterns based on presenting symptoms and to suggest algorithms for determining pattern and herbal prescriptions for corresponding patterns. The investigators collected symptom data of 67 IBD patients who achieved and maintained clinical remissions after they had taken herbal medicine prescriptions. Prescriptions were categorised into 5 patterns, which were named after main features and symptoms of included patients. Associations between presenting symptoms and patterns were visualised using a term frequency inverse document frequency (TF-IDF) method. Determining IBD patterns from symptoms of patients was analysed and charted by decision tree modeling.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2015

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

7.3 years

First QC Date

March 3, 2020

Last Update Submit

March 4, 2020

Conditions

Keywords

Herbal prescriptionHerbal medicinePattern identificationAlgorithmDecision treeTF-IDF

Outcome Measures

Primary Outcomes (1)

  • Accuracy of pattern identification algorithm

    Pattern identification algorithm was suggested using a decision tree method. Decision tree method was employed to explore the process of decision making on types of pattern based on clinical features of patients.

    Oct 2015

Study Arms (1)

Decision tree algorithm training/testing

The investigators divided data of 67 patients into 5 groups to do 5 fold cross validation. Four groups were used to train decision tree algorithm and one group was used to test it.

Other: Decision tree modeling

Interventions

A decision tree analysis was employed to explore the process of decision-making on types of pattern based on the existence or nonexistence of a symptom. At the end of tree presented is the proportion of patients who are categorised into each pattern. In this study, the classification was performed by applying the classification and regression tree (CART) algorithm using Scikit-learn package of Python, which performs a division using the Gini coefficient or the decrement of dispersion. The Gini coefficient is one of the tools for measuring entropy or diversity in each node and it measures the decrement by comparing the information entropy before and after separation. To avoid overfitting, the maximum number of leaf nodes was limited to four and the pruning method which complied with the principle of minimum description length was applied.

Decision tree algorithm training/testing

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who had been diagnosed with IBD by gastroenterologist and achieved clinical remission after treatment with herbal medicine prescriptions

You may qualify if:

  • Diagnosis of IBD by gastroenterologist
  • Patients have achieved and maintained clinical remission of IBD symptoms after they took herbal prescriptions
  • Patients have provided written informed consent

You may not qualify if:

  • Details regarding any of 25 symptoms were omitted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acupuncture & Meridian Science Research Centre

Seoul, 02447, South Korea

Location

Related Publications (6)

  • Bernstein CN, Fried M, Krabshuis JH, Cohen H, Eliakim R, Fedail S, Gearry R, Goh KL, Hamid S, Khan AG, LeMair AW, Malfertheiner, Ouyang Q, Rey JF, Sood A, Steinwurz F, Thomsen OO, Thomson A, Watermeyer G. World Gastroenterology Organization Practice Guidelines for the diagnosis and management of IBD in 2010. Inflamm Bowel Dis. 2010 Jan;16(1):112-24. doi: 10.1002/ibd.21048.

    PMID: 19653289BACKGROUND
  • Panaccione R, Rutgeerts P, Sandborn WJ, Feagan B, Schreiber S, Ghosh S. Review article: treatment algorithms to maximize remission and minimize corticosteroid dependence in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2008 Sep 15;28(6):674-88. doi: 10.1111/j.1365-2036.2008.03753.x.

    PMID: 18532990BACKGROUND
  • Abitbol V, Lahmek P, Buisson A, Olympie A, Poupardin C, Chaussade S, Lesgourgues B, Nahon S. Impact of complementary and alternative medicine on the quality of life in inflammatory bowel disease: results from a French national survey. Eur J Gastroenterol Hepatol. 2014 Mar;26(3):288-94. doi: 10.1097/MEG.0000000000000040.

    PMID: 24407360BACKGROUND
  • Lee MS, Lee JA, Alraek T, Bian ZX, Birch S, Goto H, Jung J, Kao ST, Moon SK, Park B, Park KM, You S, Yun KJ, Zaslawski C. Current research and future directions in pattern identification: Results of an international symposium. Chin J Integr Med. 2016 Dec;22(12):947-955. doi: 10.1007/s11655-014-1833-3. Epub 2014 Jun 18.

    PMID: 24938445BACKGROUND
  • Yu F, Takahashi T, Moriya J, Kawaura K, Yamakawa J, Kusaka K, Itoh T, Morimoto S, Yamaguchi N, Kanda T. Traditional Chinese medicine and Kampo: a review from the distant past for the future. J Int Med Res. 2006 May-Jun;34(3):231-9. doi: 10.1177/147323000603400301.

    PMID: 16866016BACKGROUND
  • Liu B, Zhou X, Wang Y, Hu J, He L, Zhang R, Chen S, Guo Y. Data processing and analysis in real-world traditional Chinese medicine clinical data: challenges and approaches. Stat Med. 2012 Mar 30;31(7):653-60. doi: 10.1002/sim.4417. Epub 2011 Dec 9.

    PMID: 22161304BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Hyangsook Lee, Doctor

    Kyunghee University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 5, 2020

Study Start

November 1, 2007

Primary Completion

February 28, 2015

Study Completion

October 28, 2015

Last Updated

March 6, 2020

Record last verified: 2020-03

Locations