Respiratory InfectionsPhase 2NCT01167686
Effects of Gardemont S.A Food Supplement on Upper Respiratory Illness
A Phase 2 study testing Gardemont Goldtrain Plus (GT+) in people with Respiratory Infections, run by Meir Medical Center at 1 site in Israel.
Trial summary
General:Prospective, randomized, double blind controlled trial of the food supplement GOLDTRAIN PLUS, to assess its safety and efficacy in comparison to placebo in subjects with upper respiratory infection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Infections
- What is being tested?
- Gardemont Goldtrain Plus (GT+)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2010to Dec 2012
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent
- Age eligible (18 ≤ Age ≤ 90)
- Respiratory infection with or without fever-
Who cannot join
- Evidence of the bacterial infection
- Symptoms suggestive of other than respiratory system illness (i.e. diarrhea, abdominal pain, skin rash, urinary symptoms).
- Hospitalisation is planned
- Surgery within previous 2 months
- Pregnancy (women at childbirth age should have a urine beta-HCG test performed)
- Subject with known renal dysfunction (creatinine ≥ 2 mg/dL)
Show all 9Show fewer
- Subject has history of debilitating liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ ULN
- Participation in the active follow-up phase of another clinical study of an investigational drug or device
- Known hypercalcemia -
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Revivim and Mashabei Sadeh Clalit Clinics
Beersheba
Assi Cicurel, 972-54-2401500, cicurels@gmail.com
Yael Peleg, MA, 972-8-6479941, ypeleg@bgu.ac.il
About this study
Official title: Phase 2 Study of Gardemont S.A Food Supplement on Symptoms of Upper Respiratory Illness
General:Prospective, randomized, double blind controlled trial of the food supplement GOLDTRAIN PLUS, to assess its safety and efficacy in comparison to placebo in subjects with upper respiratory infection.
Hypothesis: The food supplement GOLDTRAIN PLUS will be superior to placebo in shortening the time to recovery from the disease symptoms.
Read more
Study design and outcome measures:Study population of 182 generally healthy subjects with acute respiratory infection randomized in 1:1 ratio to active supplement versus placebo treatment, with randomization stratified by site. The study supplement administration will be continued for 7 days, and patient global assessment (PGA) will be the main primary measurement tool, based on a self-reporting questionnaire filled and monitored every 12 hours for 7 consecutive days. Throat and nasal swabs determining type of viral infection, will be taken at inclusion of patient and a number of blood tests at the end of treatment to look for any adverse effects of the medication.
Analysis and conclusion: All data-from the filled questionnaires, clinical follow up and laboratory studies will be analyzed by multivariate analysis to determine the efficacy of the supplement and its correlation to the clinical and laboratory parameters.
- Conditions
- Respiratory Infections
- Being tested
- Gardemont Goldtrain Plus (GT+)
- Keywords
- Respiratory infection, Viral infection, Food supplement, Goldtrain Plus (GT+)
- Medical subject headings
- Respiratory Tract Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gardemont Goldtrain Plus (GT+)Dietary supplement
Four tablets of 760 mg of GT+ administered three times a day for seven consecutive days and similar placebo tablets given to the control arm
| Study group | Role | What they receive |
|---|---|---|
| Food supplement | Experimental | Half of the subjects participating in the trial (91) will recieve four tablets of the food supplement (Gardemont Goldrain Plus) three times a day for seven consecutive days from inclusion. Receives: Dietary Supplement: Gardemont Goldtrain Plus (GT+) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Global Assessment (PGA)
Patient global assessment (PGA) will be a primary measurement, based on the self-reporting answer to the following question: "What is your overall feeling as compared to the first day of treatment: worse, same or better". Time from the enrollment to the first 12 hours when the subject reports on a sustained improvement in symptoms (two consequent 12 hours periods) will be a primary outcome. The study supplement administration will be continued for 7 days.
Measured: Seven days
Secondary outcomes (1)
Rate of safety composite
Death, hospitalizations, serious adverse effects
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2010
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InfectionsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ben-Gurion University of the Negev, Clalit Health Services
- Responsible party
- Sponsor
- Investigators
- Zvi Bentwich, MD, Study director, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167686
- Sponsor's protocol ID
- k008/2010
- Status last verified
- Mar 2012
- First submitted
- 21 Jul 2010
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Gardemont S.A Food Supplement on Symptoms of Upper Respiratory Illness
- ClinicalTrials.gov ID
- NCT01167686
- Acronym / sponsor ID
- k008/2010
- Conditions
- Respiratory Infections
- Keywords
- Respiratory infection, Viral infection, Food supplement, Goldtrain Plus (GT+)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- Ben-Gurion University of the Negev, Clalit Health Services
- Study start
- Mar 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 22 Jul 2010 (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.
General:Prospective, randomized, double blind controlled trial of the food supplement GOLDTRAIN PLUS, to assess its safety and efficacy in comparison to placebo in subjects with upper respiratory infection.
Hypothesis: The food supplement GOLDTRAIN PLUS will be superior to placebo in shortening the time to recovery from the disease symptoms.
Study design and outcome measures:Study population of 182 generally healthy subjects with acute respiratory infection randomized in 1:1 ratio to active supplement versus placebo treatment, with randomization stratified by site. The study supplement administration will be continued for 7 days, and patient global assessment (PGA) will be the main primary measurement tool, based on a self-reporting questionnaire filled and monitored every 12 hours for 7 consecutive days. Throat and nasal swabs determining type of viral infection, will be taken at inclusion of patient and a number of blood tests at the end of treatment to look for any adverse effects of the medication.
Analysis and conclusion: All data-from the filled questionnaires, clinical follow up and laboratory studies will be analyzed by multivariate analysis to determine the efficacy of the supplement and its correlation to the clinical and laboratory parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Food supplement | Experimental | Dietary Supplement: Gardemont Goldtrain Plus (GT+)Half of the subjects participating in the trial (91) will recieve four tablets of the food supplement (Gardemont Goldrain Plus) three times a day for seven consecutive days from inclusion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed Informed Consent
- Age eligible (18 ≤ Age ≤ 90)
- Respiratory infection with or without fever-
Key exclusion criteria (9 listed)
- Evidence of the bacterial infection
- Symptoms suggestive of other than respiratory system illness (i.e. diarrhea, abdominal pain, skin rash, urinary symptoms).
- Hospitalisation is planned
- Surgery within previous 2 months
- Pregnancy (women at childbirth age should have a urine beta-HCG test performed)
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 |
|---|---|---|
| Gardemont Goldtrain Plus (GT+)Four tablets of 760 mg of GT+ administered three times a day for seven consecutive days and similar placebo tablets given to the control arm | Dietary supplement | Food supplement |
Primary outcome
Patient Global Assessment (PGA)
Time frame: Seven days
Patient global assessment (PGA) will be a primary measurement, based on the self-reporting answer to the following question: "What is your overall feeling as compared to the first day of treatment: worse, same or better". Time from the enrollment to the first 12 hours when the subject reports on a sustained improvement in symptoms (two consequent 12 hours periods) will be a primary outcome. The study supplement administration will be continued for 7 days.
1 secondary outcome
Rate of safety composite
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
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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.
Zvi Bentwich, MD study director
Ben-Gurion University of the Negev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gardemont Goldtrain Plus (GT+) in people with Respiratory Infections, run by Meir Medical Center at 1 site in Israel.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 19 Mar 2012. 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Assi Cicurel, MD (972-54-2401500, cicurels@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Global Assessment (PGA) (time frame: Seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2012.