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Effect of Yukgunja-tang on patients with functional dyspepsia classified by 3-Dimensional Facial Shape Diagnostic System: a randomized, double-blinded, placebo-controlled, multi-center clinical trial

Status Approved

First Submitted Date

2016/05/02
Registered Date

2016/05/16
Last Updated Date

2017/10/20

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0001920
Unique Protocol ID	2016-01
Public/Brief Title	Effect of Yukgunja-tang on patients with functional dyspepsia classified by 3-Dimensional Facial Shape Diagnostic System
Scientific Title	Effect of Yukgunja-tang on patients with functional dyspepsia classified by 3-Dimensional Facial Shape Diagnostic System: a randomized, double-blinded, placebo-controlled, multi-center clinical trial
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2016-01
Approval Date	2016-04-29
Institutional Review Board Name	DONG-EUI University Korean Medical Hospital Institutional Review Board
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	SOO HYUNG JEON
Title	Assistant Professor
Telephone	+82-51-850-8904
Affiliation	Dong-Eui University Oriental Medicine Hospital
Address	62, Yangjeong-ro, Busanjin-gu, Busan, 47227, Rep. of KOREA
Contact Person for Public Queries
Name	SOO HYUNG JEON
Title	Assistant Professor
Telephone	+82-51-850-8904
Affiliation	Dong-Eui University Oriental Medicine Hospital
Address	62, Yangjeong-ro, Busanjin-gu, Busan, 47227, Rep. of KOREA
Contact Person for Updating Information
Name	SOO HYUNG JEON
Title	Assistant Professor
Telephone	+82-51-850-8904
Affiliation	Dong-Eui University Oriental Medicine Hospital
Address	62, Yangjeong-ro, Busanjin-gu, Busan, 47227, Rep. of KOREA

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Multi-center Number of center : 2
Overall Recruitment Status	Recruiting
Date of First Enrollment	2016-07-18 Actual
Target Number of Participant	96
Primary Completion Date	2017-11-30 , Anticipated
Study Completion Date	2017-11-30 , Anticipated
Name of Study	Dong-Eui University Oriental Medicine Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2016-07-27 ,
Recruitment Status by Participating Study Site 2
Name of Study	Kyung Hee University Oriental Medical Center
Recruitment Status	Active, not recruiting
Date of First Enrollment	2016-07-18 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Ministry of Health & Welfare
Organization Type	Government
Project ID	HI15C3114

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Dong-Eui University Oriental Medicine Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Hyungsang Medicine(HM) is a korean medical theory based on "Donguibogam(東醫寶鑑)". Its diagnosis is based on the person's facial shape. 3-Dimensional Facial Shape Diagnostic System(3-FSDS) was developed to compensate for subjective judgment of professionals of HM. Through the clinical trial, 3-FSDS has been approved as a medical device from KFDA. Yukgunja-tang is known to have an efficacy on the functional dyspepsia and a basic preion of bladder body in HM. IF there are more significant effect in bladder body than gallbladder body which are classified by 3-FSDS, It will be evidence of the clinical effectiveness of 3-FSDS. In this trial, we want to prove the effectiveness of 3-FSDS using a randomized, double-blind, placebo-controlled study. We will recruit patients with functional dyspepsia and classify them as bladder body group and gallbladder body group by 3-FSDS. 64 patients who are 32 bladder body and 32 gallbladder body will be belong to YT group which will be provided HanShin Yukgunja-tang Granule and take 1 pack 5g, three times a day, for 8 weeks. 32 patients who are 16 bladder body and 16 gallbladder body will be belong to placebo group which will be provided placebo granule and take 1 pack 5g, three times a day, for 8 weeks. After 8 weeks we will evaluate comparison of the effect of each group.

Study Summary Information

Lay Summary

Hyungsang Medicine(HM) is a korean medical theory based on &quot;Donguibogam(東醫寶鑑)&quot;. Its diagnosis is based on the person&#39;s facial shape. 3-Dimensional Facial Shape Diagnostic System(3-FSDS) was developed to compensate for subjective judgment of professionals of HM. Through the clinical trial, 3-FSDS has been approved as a medical device from KFDA.
Yukgunja-tang is known to have an efficacy on the functional dyspepsia and a basic preion of bladder body in HM. IF there are more significant effect in bladder body than gallbladder body which are classified by 3-FSDS, It will be evidence of the clinical effectiveness of 3-FSDS. 
In this trial, we want to prove the effectiveness of 3-FSDS using a randomized, double-blind, placebo-controlled study. We will recruit patients with functional dyspepsia and classify them as bladder body group and gallbladder body group by 3-FSDS.  64 patients who are 32 bladder body and 32 gallbladder body will be belong to YT group which will be provided HanShin Yukgunja-tang Granule and take 1 pack 5g, three times a day, for 8 weeks. 32 patients who are 16 bladder body and 16 gallbladder body will be belong to placebo group which will be provided placebo granule and take 1 pack 5g, three times a day, for 8 weeks. After 8 weeks we will evaluate comparison of the effect of each group.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Diagnosis
Phase	Phase4
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Drug
Intervention Description	HanShin Yukgunja-tang Granule was extracted from Koeran herbal medicine based on the preion of Yukgunja-tang by HanKookShinYak Pharmaceutical Co., Ltd. (Nonsan, Korea). patients in YT group will be required to take 1 pack (5g), three times a day, before and between meals for 8 weeks. placebo granule was prepared by the same supplier and was designed to taste, smell and look similar to the HanShin Yukgunja-tang Granule. Patients in placebo group will be required to take 1 pack (5g), three times a day, before and between meals for 8 weeks.
Number of Arms	2
Arm 1	Arm Label Yukgunja-tang group (YT group)
	Target Number of Participant 64
	Arm Type Experimental
	Arm Description YT group will be provided HanShin Yukgunja-tang Granule of Korean herbal extracts, which were prepared by HanKookShinYak Pharmaceutical Co., Ltd. (Nonsan, Korea) and will be required to take 1 pack (5g) three times a day, before and between meals, for 8 weeks.
Arm 2	Arm Label Placebo group
	Target Number of Participant 32
	Arm Type Placebo comparator
	Arm Description placebo group will be provided placebo granules, which were prepared by the same supplier and were designed to taste, smell and look similar to the HanShin Yukgunja-tang Granule and will be required to take 1 pack (5g), three times a day before and between meals for 8 weeks.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (K00-K93)Diseases of the digestive system (K30)Functional dyspepsia
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~75Year
	Description 1. Individuals between the ages of 19 and 75 years 2. Individuals who meet the Rome III functional dyspepsia criteria 3. Individuals who check more than 40 points on the visual analogue scale (0-100) for dyspeptic symptoms 4. Individuals who voluntarily agree with a study protocol and sign a written informed consent
Exclusion Criteria	1. Individuals who have peptic ulcer or gastroesophageal reflux disease 2. Individuals who have obvious signs of irritable bowel syndrome 3. Individuals who have alarm symptoms (weight loss, black or tar stool, or dysphagia) 4. Individuals who have serious structural disease (malignant tumors, disease of heart, lung, liver or kidney) or mental illness 5. Individuals who have had surgery related with the gastrointestinal tract, except for appendectomy more than six months ago 6. Individuals who have other structural disease related with the gastrointestinal tract (e.g., cholangitis, pancreatitis) 7. Individuals who have had maxillofacial surgery or facial bone contouring surgery 8. Individuals who are taking drugs which might affect the gastrointestinal tract (Proton-pump inhibitors(PPIs), H2 antagonists, Antacids, gastrointestinal motility promoters, antibiotics, Nonsteroidal anti-inflammatory drugs(NSAIDs), muscle relaxants, antidepressants, stabilizer); a minimum wash-out period of one week is required before participating in the trial 9. Individuals who are pregnant or breastfeeding 10. Individuals who have a problem of malabsorption or maldigestion 11. Individuals who are human immunodeficiency virus(HIV) positive 12. Individuals who have difficulty in attending the trial (e.g., severe mental or psychological abnormality, dementia, drug addiction, time constraint, severe disorder in vision or hearing, outpatient treatment impossibility, illiteracy) 13. Individuals who have taken any other Investigational drug within 3 months
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Total Dyspepsia Symptom(TDS) Scale
Timepoint	Visit 1(0week), Visit 2(4week), Visit 3(8week)
Secondary Outcome(s) 1
Outcome	Single Dyspepsia Symptom(SDS) Scale
Timepoint	Visit 1(0week), Visit 2(4week), Visit 3(8week)
Secondary Outcome(s) 2
Outcome	Visual Analogue Scale (VAS)
Timepoint	Screening visit, Visit 1(0week), Visit 2(4week), Visit 3(8week)
Secondary Outcome(s) 3
Outcome	Nepean Dyspepsia Index (NDI)
Timepoint	Visit 1(0week), Visit 2(4week), Visit 3(8week)
Secondary Outcome(s) 4
Outcome	Functional dyspepsia-related quality of life (FD-QoL)
Timepoint	Visit 1(0week), Visit 2(4week), Visit 3(8week)
Secondary Outcome(s) 5
Outcome	Spleen Qi Deficiency Questionnaire (SQDQ)
Timepoint	Visit 1(0week), Visit 2(4week), Visit 3(8week)
Secondary Outcome(s) 6
Outcome	Adequate relief(AR) of FD pain & discomfort
Timepoint	Every week after Visit 1

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

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