Condition category
Digestive System
Date applied
02/08/2007
Date assigned
16/08/2007
Last edited
16/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr John Heggers

ORCID ID

Contact details

13266 FM 362
Navasota
77868
United States of America
+1 936 825 2389
jheggers@msn.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Small doses of purified d-Limonene (approximately 1000 mg) will ameliorate symptoms of indigestion and heartburn.

Ethics approval

Members of the research team were affiliated with a University of Texas Medical Branch (UTMB) but WRC Labs has no affiliation with a university so approval from a University Institutional Review Board (IRB) could not be gained. Prior to initiating the study, an independent group from the university community was convened to review the study related to the three basic principles of ethics relevant to the protection of human subjects in research: respect for persons, beneficence and justice and they unanimously approved the study. Plans to seek University IRB approval will not be made unless a follow up study is performed.

Study design

Randomised double blind placebo controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Gastrointestinal discomfort (indigestion/heartburn)

Intervention

Participants were randomised to ten (10) capsules of d-Limonene or placebo and instructed to take capsules orally and report symptom relief as instructed on provided questionnaire daily.

Capsules taken daily for ten days or every other day for twenty days for relief of symptoms of indigestion/heartburn.

Intervention type

Drug

Phase

Not Specified

Drug names

Purified d-Limonene

Primary outcome measures

Relief of symptoms as reported subjectively by study participants daily for twenty days. Participants rated their symptom relief on the original questionnaires to day 20.

Secondary outcome measures

Continued relief of symptoms after completing 10 capsules. A follow up questionnaire was sent out at the six month time-point for feedback on continued relief of symptoms.

Overall trial start date

01/09/2000

Overall trial end date

30/06/2001

Reason abandoned

Eligibility

Participant inclusion criteria

Adults over 18 years of age who have experienced symptoms of indigestion and/or heartburn for at least six months.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

50

Participant exclusion criteria

1. Known sensitivity to citrus products or by products
2. Known sensitivity to soy bean oil
3. History of gastrointestinal bleeding or ulcers
4. Pregnancy

Recruitment start date

01/09/2000

Recruitment end date

30/06/2001

Locations

Countries of recruitment

United States of America

Trial participating centre

13266 FM 362
Navasota
77868
United States of America

Sponsor information

Organisation

WRC Laboratories LP (USA)

Sponsor details

13266 FM 362
Navasota
77868
United States of America
+1 936 825 2389
magnum@nol.net

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

WRC Laboratories LP (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes