Clinical research conducted in healthy subjects not suffering from gastrointestinal and gastrointestinal diseases in Japan
Conditions
Interventions
None listed
Sponsors
Adaptgen Pharmaceutical Co., Ltd. Sales Planning Division & Clinical development division
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Stool frequency 2. Days of defecation 3. Bowel movement | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Stool hardness 2. Stool color 3. Stool shape 4. Refreshing feeling | — |
Countries
Japan
Contacts
Public ContactToru Urakawa
Adaptgen Pharmaceutical Co., Ltd. Sales Planning Division & Clinical development division
Outcome results
None listed