Status:
COMPLETED
Safety Study of the Effect of Scelectium Tortuosum (as Zembrin®)in Aged Normals
Lead Sponsor:
Woodbury, Michel, M.D.
Collaborating Sponsors:
PL Thomas & Co., Inc.
Conditions:
Adverse Mental/Physical Effects of Low Dose S. Tortuosum.
Eligibility:
All Genders
45-65 years
Phase:
PHASE1
Brief Summary
Phosphodiesterase is a candidate for the Rx \& prevention of cognitive and psychotic disorders. Since caffeine targets primarily PDE4(Phosphodiesterase subtype 4), caffeine analogs have been developed...
Detailed Description
1\. Contextual Background For the past decade, converging evidence suggests that targeting PD Phosphodiesterase for cognition represents novel heuristic approaches for development of dietary supplemen...
Eligibility Criteria
Inclusion
- Male or female Age: 45-65 Absence of DSM IV-R diagnosis As established by Mini-Psychiatric Interview HAM-D \< 8 Body Mass Index (BMI) \< 30.0 Not Suicidal
Exclusion
- Current (past 2 months) substance use disorder, Abuse of Caffeine Severe nicotine dependence Abuse of herbal and dietary supplements Current or planned pregnancy (for female) A major DSM IV-R psychiatric diagnosis.
- Serious and unstable medical disorders:
- Recent myocardial ischemia or infarction, unstable angina, uncontrolled hypertension, poor glycemic control in Diabetes mellitus, Renal failure and serious renal diseases, Chronic active hepatitis, acute hepatitis, cirrhosis of liver, AIDS Active malignancy Neurological disorders: epilepsy Recent Traumatic brain injury Active suicidal risk Cerebrovascular disorders: recent stroke Inability to read nor write
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01805518
Start Date
June 1 2011
End Date
March 1 2012
Last Update
March 6 2013
Active Locations (1)
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1
Michel A. Woodbury, MD
San Juan, Puerto Rico, 00918