healthy by medical history Urolithesis,
Conditions
Interventions
The active ingredient contains Citric acid,
natural antioxidants and water,Placebo used in this research is a solution that produces a taste,
color and smell similar to HydraZitLa (Sweet and sour,
red-
purple,
blueberry flavor) using food additives at the Food and Drug Administration Ministry of Public Health allowed INS 260 (acetic acid),
Active Comparator Drug,Placebo Comparator Drug
Sponsors
faculty of medicine Chulalongkorn University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Subjects whose BMI is 18-25 kg/m2 (inclusive). 2. Subjects who are healthy by medical history, physical examination and vital signs. 3. Subject whose screening visit laboratory values of blood tests including complete blood count, fasting blood sugar, blood urea nitrogen, serum creatinine, alkaline phosphatase, ALT, AST, total bilirubin, direct bilirubin, albumin and electrolytes are within the normal range or showing no clinically significant abnormalities as confirmed by the clinical investigator. 4. For female subjects: Female subject who is in childbearing potential must have serum β-HCG negative and agrees to use an acceptable birth control method from visit 1 to the last visit. The acceptable birth control method is defined as a barrier method of contraception (including condoms, intrauterine device (IUD) and diaphragm with spermicial agent) or total abstinence from sexual intercourse from visit 1 to the last visit. Hormonal contraceptives are not acceptable. Female subject who is in child bearing potential must agree not to become pregnant for the entire participation phase and must have a negative result for urine pregnancy test performing prior to dosing. Female subjects can be those with non-childbearing potential which defined as female subjects with hysterectomy, both ovaries removed, surgically sterilized or postmenopausal (for at least 12 consecutive months of amenorrhea). 5. Subjects are able to understand the requirements of the study and voluntarily sign and date an informed consent, approved by the Independent Ethic Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
Exclusion criteria
Exclusion criteria: 1.Subjects who are with a history/evidence of allergy or hypersensitivity to banana, or Hydrozitla. 2.Subjects who have a history of any illness that, in the opinion of the clinical investigator, might confound the result of the study or pose an additional risk in administrating Hydrozitla to the subjects. This may include but not limited to: a history of having urinary stone disease or having symptoms suspected of urinary stone disease; a history of relevant drug or food allergies; history or cardiovascular, gastrointestinal, central nervous system disease, renal and hepatic impairment, malignancy; history or presence of clinically significant illness; or history of mental illness that may affect compliance with study requirements. 3. Subjects who are with a history of heavy smoking (more than 10 cigarettes per day) or moderate smoking (less than 10 cigarettes per day) and cannot omit smoking at least one day before the study and until the completion of the study phase. 4. Subjects who are with a history of alcoholic (more than 2 years) or moderate drinkers (more than 3 drinks per day – one is equal to one unit of alcohol: - one glass of wine, half pine of beer or one measure of spirit) or subjects who are with a history of any drug abuse. 5. Subjects who receive of any medical prescription within 1 4 days before the first administration of Hydrozitla. 6. Female subjects who are pregnant or breast feeding. 7. Subjects who are participating in any investigational drug study or had been in any investigational drug study or had donated blood within 2 months prior to the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Citrate 6 months after end of the intervention blood and urine tests | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse effect 6 months after end of the intervention blood and urine tests,ageing marker 6 months after end of the intervention blood and urine tests,acute toxicity 6 months after end of the intervention blood and urine tests,oxalate 6 months after end of the intervention blood and urine tests,plasma 8-OHdG 6 months after end of the intervention blood and urine tests,plasma protein 6 months after end of the intervention blood and urine tests | — |
Countries
thailand
Contacts
Public Contactchanchai boonla
faculty of medicine Chulalongkorn University
Outcome results
None listed