SECURITY AND TOLERANCE OF UNCARIA TOMENTOSA (WILLD) DC IN HEALTHY VOLUNTEERS

Not Applicable

Conditions: -Z00 General examination and investigation of persons without complaint and reported diagnosis
General examination and investigation of persons without complaint and reported diagnosis
Z00

Registration Number: PER-037-08

Lead Sponsor: Instituto Nacional de Salud - INS (Peru),

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 0

Inclusion Criteria

• Volunteers considered healthy by clinical and laboratory evaluation.
• That you agree to be considered within the study.
• Women who are not gestating or giving breastfeeding
• Sign your consent to participate.

Exclusion Criteria

• Volunteers who present a disease or symptomatology.
• Volunteers who are ingesting some type of drug or vitamin supplement.
• Patients who do not wish to sign the informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:The verbal manifestations of the volunteer will be considered on any symptom, the vital signs, the biological functions as well as the anthropometric measurement will be monitored.<br>Measure:Variations in clinical evaluation<br>Timepoints:During the study<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Hematological Profile: Hemoglobin, CBC. platelet count.<br>Renal profile: Creatinine, urea, urinary sediment, chemical urine test (uri-test method 9). Liver profile<br>Immunological profile: CD4 and CD8<br>Other tests: Glucose, cholesterol, LDL, HDL and uric acid<br>Measure:Variation in the levels of laboratory tests<br>Timepoints:During the study<br>;<br>Outcome name:Electrocardiogram during the study<br>Measure:Variations in the eiectrocardiographic Registry.<br>Timepoints:During the study<br>;<br>Outcome name:An ophthalmological profile will be performed during the study<br>Measure:Variations in the ophthalmological profile<br>Timepoints:During the study<br>;<br>Outcome name:An endoscopic study with biopsy will be conducted, which will be directed by the gastroenterologist. This sample will be taken at the beginning and at 90 days of treatment. The sample will be evaluated by the pathologist.<br>Measure:Variations in endoscopic evaluation with biopsy<br>Timepoints:During the study<br>