UMIN-CTR Clinical Trial

Public title

The systematical review a functionality participation ingredient "psyllium" exerts on constipated improvement

Acronym

The systematical review a functionality participation ingredient "psyllium" exerts on constipated improvement

Scientific Title

The systematical review a functionality participation ingredient "psyllium" exerts on constipated improvement

Scientific Title:Acronym

The systematical review a functionality participation ingredient "psyllium" exerts on constipated improvement

Region

Japan

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

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

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

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Toru Urakawa

Organization

Adaptgen Pharmaceutical Co., Ltd.

Division name

Sales Planning Division & Clinical development division

Zip code

Address

1-90-1, Kamiyama-cho, Tajimi-shi, Gifu, 5070022, Japan

TEL

0572-56-1111

Email

adurakawa@adaptgen.co.jp

Name of contact person

1st name
Middle name
Last name	Toru Urakawa

Organization

Adaptgen Pharmaceutical Co., Ltd.

Division name

Sales Planning Division & Clinical development division

Zip code

Address

1-90-1, Kamiyama-cho, Tajimi-shi, Gifu, 5070022, Japan

TEL

0572-56-1111

Homepage URL

Email

adurakawa@adaptgen.co.jp

Institute

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

Institute

Department

Personal name

Organization

Adaptgen Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

02

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2017

Year

02

Month

10

Day

Date of IRB

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

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.

Registered date

2017

Year

02

Month

16

Day

Last modified on

2017

Year

03

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030044