Lime Powder Regimen in Healthy Volunteers

Oxidative Stress Clinical Trial

— LimePKphase1  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01273025
• Other study ID #: PPK-10-003
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: January 5, 2011
• Last updated: January 7, 2011
• Start date: December 2010
• Est. completion date: March 2011

Study information

• Verified date: January 2011
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The study aims to investigate the pharmacokinetic parameters and its antioxidative effects in Thai healthy men.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Nephrolithiasis
• Oxidative Stress

Intervention

Dietary Supplement:
• Lime powder regime
1 sachet of lime powder regimen with 200 ml of water

Locations

Country	Name	City	State
Thailand	Chula clinical research center	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months	No