Abdominal Pain/ DiscomfortNCT01931930
Effect of Perilla Extract on Improvement on Gastrointestinal Discomfort
A study testing Perilla extract and Maltodextrin in people with Abdominal Pain/ Discomfort and Slightly Constipation, run by Amino Up Chemicals Co., Ltd. at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Pain/ Discomfort, Slightly Constipation
- What is being tested?
- Perilla extract and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2012to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility.
- BMI: 19-30 kg/m2
- Reduced bowel movements defined as an average of >1 and ≤ 3.5 stools per week for at least the previous 6 months
- Gastrointestinal symptoms of at least 5 points
- Male or female
- Age ≥ 30 and ≤ 70 years
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- Nonsmoker
- Written consent to participate in the study
- Able and willing to follow the study protocol procedures
Who cannot join
- Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries
- Relevant history, presence of any medical disorder or intake of medication / dietary supplements, potentially interfering with this trial at screening
- Subjects with stool frequency of ≤ 1 stool every 7 days or > 3,5 stools per week
- Subjects not willing to avoid pre- and probiotics for the duration of the study
- Intake of antibiotics in the last 4 weeks and laxatives in the last 2 weeks
- Change of dietary habits within the 4 weeks prior to screening (for instance start of a diet high in fibers)
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- Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject.
- Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study.
- Participants anticipating a change in their lifestyle or physical activity levels since this may also influence the results.
- Known food intolerance or allergy.
- Subject involved in any clinical or food study within the preceding month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Perilla Extract on Improvement of Intestinal Discomfort and Bowel Function in Healthy Volunteers With Gastrointestinal Discomfort
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).
- Conditions
- Abdominal Pain/ Discomfort, Slightly Constipation
- Being tested
- Perilla extract, Maltodextrin
- Keywords
- Gastrointestinal discomfort, Perilla frutescens, bloating, abdominal discomfort, human study, healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perilla extractDietary supplement
MaltodextrinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Perilla extract | Experimental | Experimental arm: Perilla extract Receives: Dietary Supplement: Perilla extract |
| Maltodextrin | Placebo comparator | Placebo arm: Maltodextrin Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: was assessed daily during 4 week intervention
Secondary outcomes (4)
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.
- Patient assessment of constipation symptoms (PAC SYM)
- Patents assessment of constipation quality of life (PAC QOL)
- Perceived stress questionnaire (PSQ20)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: reported at days with stool during 4 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startJul 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Pain/ DiscomfortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amino Up Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Menzel, PhD, Principal investigator, BioTeSys GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931930
- Sponsor's protocol ID
- BTS656/12
- Status last verified
- Aug 2013
- First submitted
- 23 Aug 2013
- Last updated
- 30 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Buchwald-Werner S, Fujii H, Reule C, Schoen C. Perilla extract improves gastrointestinal discomfort in a randomized placebo controlled double blind human pilot study. BMC Complement Altern Med. 2014 May 27;14:173. doi: 10.1186/1472-6882-14-173.
PubMed 24885816
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perilla Extract on Improvement of Intestinal Discomfort and Bowel Function in Healthy Volunteers With Gastrointestinal Discomfort
- ClinicalTrials.gov ID
- NCT01931930
- Acronym / sponsor ID
- BTS656/12
- Conditions
- Abdominal Pain/ Discomfort, Slightly Constipation
- Keywords
- Gastrointestinal discomfort, Perilla frutescens, bloating, abdominal discomfort, human study, healthy subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Amino Up Chemicals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perilla extract | Experimental | Dietary Supplement: Perilla extractExperimental arm: Perilla extract |
| Maltodextrin | Placebo comparator | Dietary Supplement: MaltodextrinPlacebo arm: Maltodextrin |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility.
- BMI: 19-30 kg/m2
- Reduced bowel movements defined as an average of >1 and ≤ 3.5 stools per week for at least the previous 6 months
- Gastrointestinal symptoms of at least 5 points
- Male or female
Key exclusion criteria (11 listed)
- Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries
- Relevant history, presence of any medical disorder or intake of medication / dietary supplements, potentially interfering with this trial at screening
- Subjects with stool frequency of ≤ 1 stool every 7 days or > 3,5 stools per week
- Subjects not willing to avoid pre- and probiotics for the duration of the study
- Intake of antibiotics in the last 4 weeks and laxatives in the last 2 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perilla extract | Dietary supplement | Perilla extract |
| Maltodextrin | Dietary supplement | Maltodextrin |
Primary outcome
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.
4 secondary outcomes
validated questionnaires
Time frame: assessed at visit 1 (before) and at visit 2 (after 4 week intervention)
stool consistency
Time frame: reported at days with stool during 4 week intervention
Adverse events
Time frame: assessed at visit 1 (before) and at visit 2 (after 4 week intervention)
Stool frequency
Time frame: reported at days with stool during 4 week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2013.
- Derived from this study: PubMed 24885816Buchwald-Werner S, Fujii H, Reule C, Schoen C. Perilla extract improves gastrointestinal discomfort in a randomized placebo controlled double blind human pilot study. BMC Complement Altern Med. 2014 May 27;14:173. doi: 10.1186/1472-6882-14-173.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Menzel, PhD principal investigator
BioTeSys GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perilla extract and Maltodextrin in people with Abdominal Pain/ Discomfort and Slightly Constipation, run by Amino Up Chemicals Co., Ltd. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
daily gastrointestinal symptoms (time frame: was assessed daily during 4 week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01931930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2013.