UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The systematical review a functionality participation ingredient "psyllium" exerts on constipated improvement
Title of the study (Brief title)	The systematical review a functionality participation ingredient "psyllium" exerts on constipated improvement
Region	Japan

Condition
Condition	Clinical research conducted in healthy subjects not suffering from gastrointestinal and gastrointestinal diseases in Japan
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery Hepato-biliary-pancreatic surgery Aesthetic surgery Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	From clinical studies conducted on healthy subjects not suffering from gastrointestinal and gastrointestinal diseases, clinical research papers are orally ingested from plants-derived psyllium by a systematic analysis method "Systematic Review" By means of intervention tests, we will conduct the purpose of comprehensive evaluation and verification of efficacy and safety concerning constipation improvement (stool frequency etc.).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Stool frequency 2. Days of defecation 3. Bowel movement
Key secondary outcomes	1. Stool hardness 2. Stool color 3. Stool shape 4. Refreshing feeling

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	[PICOS] (Patients) Clinical study conducted on healthy volunteers who do not suffer from gastrointestinal or gastrointestinal diseases in Japan (Interventions) 1.Ongoing intake of psyllium containing supplements 2.Continuous intake of psyllium containing food (Control) as a control composition (control group) 1.Supplement not containing psyllium 2.Foods not containing psyllium (Outcome) 1.Continuous intake of psylium improves constipation Key Evaluation Items/Fecal Frequency Secondary endpoint/fecal shape (Study design) Controlled with placebo or non psyllium 1. Double blind parallel group comparison test 2. Single blind parallel group comparison test 3. Double blind crossover comparison test 4. Single blind crossover comparison test Contains psyllium 1. Dose setting test 2. Gradual increase / decrease test [Selection criteria (eligibility criteria)] In the primary screening, the following selection criteria (eligibility criteria) out of the candidate literature assumed to be a clinical study on oral intake of botanically-derived psyllium targeted for Japanese carried out in Japan by the abstract of medical magazine WEB, , One that corresponds to one or more is taken as a temporary candidate document. 1. Clinical research literature for domestic non-affected persons with skin 2. Literature of clinical research for adults conducted in Japan 3. Clinical research literature extracted by medical magazine WEB of literature retrieval system 4. Clinical research literature conducted by public institutions 5. Clinical research literature published by the National Institute of Agriculture and Food Industry (Agricultural Research Organization) 6. Clinical research literature adopted by the reviewer's agreement besides the medical magazine WEB
Key exclusion criteria	[Exclusion Criteria] In the secondary screening, provisional candidate documents are obtained by the abstract, and those corresponding to one or more of the following exclusion criteria are excluded from the candidate literature. 1.Clinical research literature for subjects suffering from gastrointestinal and gastrointestinal diseases 2.Clinical research literature for minors 3.Literature of clinical research for pregnant women and lactating women 4.Clinical research literature not reviewed 5.Literature of clinical study without comparative control group 6.Clinical research literature in which the main involved component is not psylium 7.Clinical research literature which can not be evaluated by glucosylceramide and other equivalent ingredients 8.In addition, clinical research literature judged inappropriate by the reviewer's agreement
Target sample size	1

Research contact person
Name of lead principal investigator	Toru Urakawa
Organization	Adaptgen Pharmaceutical Co., Ltd.
Division name	Sales Planning Division & Clinical development division
Address	1-90-1, Kamiyama-cho, Tajimi-shi, Gifu, 5070022, Japan
TEL	0572-56-1111
Email	adurakawa@adaptgen.co.jp

Public contact
Name of contact person	Toru Urakawa
Organization	Adaptgen Pharmaceutical Co., Ltd.
Division name	Sales Planning Division & Clinical development division
Address	1-90-1, Kamiyama-cho, Tajimi-shi, Gifu, 5070022, Japan
TEL	0572-56-1111
Homepage URL
Email	adurakawa@adaptgen.co.jp

Sponsor
Institute	Adaptgen Pharmaceutical Co., Ltd. Sales Planning Division & Clinical development division
Institute
Department

Funding Source
Organization	Adaptgen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 10 Day
Anticipated trial start date	2017 Year 02 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2017 Year 02 Month 20 Day
Date analysis concluded	2017 Year 02 Month 23 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	By ingesting a food-derived functional involved component "psyllium", continuous ingestion of RQ / CQ "food-derived functional component psyllium" defined in this SR research review improved constipation compared with the control group Do you let it? "The continuous use of psyllium improves the frequency of defecation, the number of days of defecation, the amount of defecation and improves constipation tendency", and "usage, dosage" confirmed efficacy and safety are as follows I came to the conclusion. 1. Effect to improve stool frequency (Direction) Once a day / 2 times / day / day (Dose) 4.0 g / day to 8.0 g / day per day 2. The effect of improving defecation days (Direction) Once a day / 2 times / day / day (Dose) 4.0 g / day to 8.0 g / day per day 3. Effect to improve defecation volume (Direction) Once a day / 2 times / day / day (Dose) 4.0 g / day to 8.0 g / day per day
Other related information	(Data extraction process) In Adaptogen Pharmaceutical Co., Ltd., "Guidelines on Notification of Functional Displayed Foods" and "Ethical Guidelines on Medical Research for Human Subjects" notified by regulatory authorities in accordance with the Functionally Displayed Food System, and other related laws, guidelines, and guidelines Based on the notification, "Standard Operating Procedure for Functionally Displayed Food etc." was established and the evaluation verification method by the systematic analysis method "Systematic Review" of the clinical research paper and the revision of the patent law (April 1, 2016) Provisions and procedures have been established and operated taking intellectual property rights (patent rights, utility model rights, design rights, trademark rights, copyrights, unfair competition prevention laws and related laws) into consideration. (Reliability and Evaluation Criteria in Clinical Research) About the evaluation of the bias risk that can be investigated with reference to "ethical guidelines on research on medical science for human beings" and GCP ministerial ordinance, Collaboration , Clinical trials including clinical physicians, clinical trial investigations committee,ethical review committee, medical experts and experts in basic research field, and 14 bias risk evaluation items and individual research bias risk The comprehensive evaluation criteria of.

Management information
Registered date	2017 Year 02 Month 16 Day
Last modified on	2017 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030044