An interventional study of Perilla extract and Maltodextrin in Abdominal Pain/ Discomfort and Slightly Constipation, sponsored by Amino Up Chemicals Co., Ltd.. Completed at 1 site in Germany. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-30.
Sponsored by Amino Up Chemicals Co., Ltd. · Not applicable, Interventional, and Supportive care
In the current study the effects of proprietary Perilla frutescens leaf extract in comparison to Maltodextrin, a fully digestible carbohydrate (placebo control), on gastrointestinal discomfort and bowel function were investigated. The study was performed double-blind and placebo-controlled with a 4 week intervention period. Study products were taken two times daily (each one capsule before breakfast and dinner).
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 47 is below the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation studies →This is the only study on the registry with Amino Up Chemicals Co., Ltd. as lead sponsor.
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Exclusion Criteria:
Experimental arm: Perilla extract
Dietary Supplement: Perilla extract
Placebo arm: Maltodextrin
Dietary Supplement: Maltodextrin
daily gastrointestinal symptoms
The following gastrointestinal were rated and reported by the study participants on a daily based. Bloating, rumbling, feeling of fullness, passage of gas, abdominal discomfort (pain and cramps). The rating was done based on a number scale. 0 not at all and 4 extremely.
Time frame: was assessed daily during 4 week intervention
validated questionnaires
Three validated questionnaires were used. Two of them were specially designed to evaluate gastrointestinal symptoms and quality of life of people with constipation. The third questionnaire was a validated questionnaire to report stress levels and related changes of stress levels. 1. Patient assessment of constipation symptoms (PAC SYM) 2. Patents assessment of constipation quality of life (PAC QOL) 3. Perceived stress questionnaire (PSQ20)
Time frame: assessed at visit 1 (before) and at visit 2 (after 4 week intervention)
stool consistency
The stool consistency was rated referring to the Bristol stool scale. A scale indicated with pictures how the stool consistency can be rated.
Time frame: reported at days with stool during 4 week intervention
Adverse events
All adverse events which might be linked to the study product were reported. As the tested study product is a food product being safe for consumption as food no specific parameter to define safety were defined.
Time frame: assessed at visit 1 (before) and at visit 2 (after 4 week intervention)
Stool frequency
The stool frequency was reported on each day with bowel movement.
Time frame: reported at days with stool during 4 week intervention
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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