A randomised double blind placebo controlled study to evaluate the effectiveness of purified d-Limonene as an agent to relieve the symptoms of indigestion and "heartburn"
| ISRCTN | ISRCTN96109983 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96109983 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/08/2007
- Registration date
- 16/08/2007
- Last edited
- 29/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr John Heggers
Scientific
Scientific
13266 FM 362
Navasota
77868
United States of America
| Phone | +1 936 825 2389 |
|---|---|
| jheggers@msn.com |
Study information
| Study design | Randomised double blind placebo controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | A randomised double blind placebo controlled study to evaluate the effectiveness of purified d-Limonene as an agent to relieve the symptoms of indigestion and "heartburn" |
| Study objectives | Small doses of purified d-Limonene (approximately 1000 mg) will ameliorate symptoms of indigestion and heartburn. |
| Ethics approval(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Purified d-Limonene |
| Primary outcome measure | 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 study start date | 01/09/2000 |
| Completion date | 30/06/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 50 |
| Key inclusion criteria | Adults over 18 years of age who have experienced symptoms of indigestion and/or heartburn for at least six months. |
| Key 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 |
| Date of first enrolment | 01/09/2000 |
| Date of final enrolment | 30/06/2001 |
Locations
Countries of recruitment
- United States of America
Study participating centre
13266 FM 362
Navasota
77868
United States of America
77868
United States of America
Sponsor information
WRC Laboratories LP (USA)
Industry
Industry
13266 FM 362
Navasota
77868
United States of America
| Phone | +1 936 825 2389 |
|---|---|
| magnum@nol.net |
Funders
Funder type
Industry
WRC Laboratories LP (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
