Effect of Perilla Extract on Improvement on Gastrointestinal Discomfort
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|ClinicalTrials.gov Identifier: NCT01931930|
Recruitment Status : Completed
First Posted : August 30, 2013
Last Update Posted : August 30, 2013
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Pain/ Discomfort Slightly Constipation||Dietary Supplement: Perilla extract Dietary Supplement: Maltodextrin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effect of Perilla Extract on Improvement of Intestinal Discomfort and Bowel Function in Healthy Volunteers With Gastrointestinal Discomfort|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Experimental: Perilla extract
Experimental arm: Perilla extract
Dietary Supplement: Perilla extract
Placebo Comparator: Maltodextrin
Placebo arm: Maltodextrin
Dietary Supplement: Maltodextrin
- daily gastrointestinal symptoms [ Time Frame: was assessed daily during 4 week intervention ]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.
- validated questionnaires [ Time Frame: assessed at visit 1 (before) and at visit 2 (after 4 week intervention) ]
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.
- Patient assessment of constipation symptoms (PAC SYM)
- Patents assessment of constipation quality of life (PAC QOL)
- Perceived stress questionnaire (PSQ20)
- stool consistency [ Time Frame: reported at days with stool during 4 week intervention ]The stool consistency was rated referring to the Bristol stool scale. A scale indicated with pictures how the stool consistency can be rated.
- Adverse events [ Time Frame: assessed at visit 1 (before) and at visit 2 (after 4 week intervention) ]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.
- Stool frequency [ Time Frame: reported at days with stool during 4 week intervention ]The stool frequency was reported on each day with bowel movement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01931930
|Esslingen, Germany, 73728|
|Principal Investigator:||Daniel Menzel, PhD||BioTeSys GmbH|