Kidney StonePhase 1LimePKphase1NCT01273025
Lime Powder Regimen in Healthy Volunteers
A Phase 1 study testing Lime powder regime in people with Kidney Stone and Oxidative Stress, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The study aims to investigate the pharmacokinetic parameters and its antioxidative effects in Thai healthy men. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Stone, Oxidative Stress
- What is being tested?
- Lime powder regime
- How many people
- 15 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2010to Mar 2011
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Thai healthy male or female aged 18-45 years old
- BMI 18-25 kg/m2
- Normal medical history, physical examination and vital signs
- Normal screening laboratories
- no history of drug allergies
- Willingness to take part in the study and provide informed consent
Who cannot join
- History of GI, liver, kidney, allergic disease or any other disease that may interfere with the bioavailability of lime powder regimen
- History of alcohol or drug abuse
- Heavy smoking
- Receive any medication within 14 days prior to the study day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medicinal Effect of Lime Powder Regimen in HK-2 Cell Exposed to Lithogenic Crystals and Its Citraturic and Antioxidative Responses in Healthy Volunteers
The study aims to investigate the pharmacokinetic parameters and its antioxidative effects in Thai healthy men.
- Conditions
- Kidney Stone, Oxidative Stress
- Being tested
- Lime powder regime
- Keywords
- pharmacokinetic, lime powder regimen, kidney stone, Oxidative stress
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lime powder regimeDietary supplement
1 sachet of lime powder regimen with 200 ml of water
What is being measured
The primary outcome is the main question the study is designed to answer.
The pharmacokinetic parameters of plasma and urine citrate
The pharmacokinetic parameters of plasma and urine citrate incluiding Cmax, Tmax, Half life, AUC, and elimination rate constant
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Investigators
- Poonsin Poungpairoj, BSc, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273025
- Sponsor's protocol ID
- PPK-10-003
- Acronym
- LimePKphase1
- Status last verified
- Jan 2011
- First submitted
- 5 Jan 2011
- Last updated
- 10 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medicinal Effect of Lime Powder Regimen in HK-2 Cell Exposed to Lithogenic Crystals and Its Citraturic and Antioxidative Responses in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01273025
- Acronym / sponsor ID
- LimePKphase1 / PPK-10-003
- Conditions
- Kidney Stone, Oxidative Stress
- Keywords
- pharmacokinetic, lime powder regimen, kidney stone, Oxidative stress
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 10 Jan 2011 (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.
The study aims to investigate the pharmacokinetic parameters and its antioxidative effects in Thai healthy men.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Thai healthy male or female aged 18-45 years old
- BMI 18-25 kg/m2
- Normal medical history, physical examination and vital signs
- Normal screening laboratories
- no history of drug allergies
Key exclusion criteria (4 listed)
- History of GI, liver, kidney, allergic disease or any other disease that may interfere with the bioavailability of lime powder regimen
- History of alcohol or drug abuse
- Heavy smoking
- Receive any medication within 14 days prior to the study day
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 |
|---|---|---|
| Lime powder regime1 sachet of lime powder regimen with 200 ml of water | Dietary supplement | – |
Primary outcome
The pharmacokinetic parameters of plasma and urine citrate
Time frame: 6 months
The pharmacokinetic parameters of plasma and urine citrate incluiding Cmax, Tmax, Half life, AUC, and elimination rate constant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2011.
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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.
Poonsin Poungpairoj, BSc principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lime powder regime in people with Kidney Stone and Oxidative Stress, run by Chulalongkorn University at 1 site in Thailand.
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 6 inclusion and 4 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 10 Jan 2011. 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 Thailand. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
The pharmacokinetic parameters of plasma and urine citrate (time frame: 6 months). 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 10 Jan 2011.