Eligibility
Inclusion criteria
Subjects will be required to satisfy the following criteria:
Male or female 18+ years of age
Willing and able to give written informed consent in the English language for participation in the Treatment
Able and agree to comply with all Treatment requirements
Have had no course of prescribed contraindicated medication in two weeks before first study dose
Willing to allow his General Practitioner, if appropriate, to be notified of participation in the study
Exclusion criteria
Patients will be excluded from the Treatment for the following reasons.
Scheduled elective surgery or other procedures requiring general anaesthesia during the study
Participation in a research study involving an investigational product in the past month
Pregnancy, planning to become pregnant or breastfeeding
Hypersensitivity or known allergy to any study agents
Current use of any dietary supplement that are specific for energy (if so 7 day washout is allowed)
Recent history (<2 years) of alcoholism or unlikely to refrain from excessive alcohol consumption during the study period, defined as >2 drinks/day
Use of any recreational drugs or a history of drug addiction
Any other significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study
or may influence the result of the study, or the subject’s ability to participate in the study
Treatment
The duration of the Treatment is 30 days.
The CKBR-12 dosage is administered twice a day with breakfast and lunch.
Vital signs, including but not limited to blood pressure, heart rate, and glucose readings are taken daily.
Questionnaires are administered on a weekly basis.
Videos are taken weekly to monitor progress
Weekly visits and sessions by psychologist
Weekly visits by our doctors
Weekly visits by neurologist
Exercise Program and Yoga
Amenities
Ocean Front Location
Private Bedroom Suite and Bathroom
Full Time Chef
Gym
Sauna
Pool
Laundry Service
Dining Out
Sightseeing
Family Visits
Discontinuation/Withdrawal of Patients from Treatment
Discontinuation/Withdrawal of Subjects from Study Treatment
Each participant has the right to withdraw from the study at any time. In addition, the investigator may discontinue a participant from the study at any time if the investigator considers it necessary for any reason including:
Ineligibility
Significant protocol deviation that has the capacity to alter the study outcome per the principal investigator’s opinion
Significant non-compliance with treatment regimen or study requirements (any non-compliance resulting in the subject not taking their study agent will prompt withdrawal from the per protocol statistical analysis
A serious adverse event (SAE) that has the capacity to alter study outcome per the principal investigator’s opinion
An adverse event which requires discontinuation of the study medication or results in inability to continue to comply with study procedures
Adverse events that will remove subjects from study (including but not limited to):
Allergy: Any allergic reaction/hypersensitivity ≥ grade 2
Neurology
Any cognitive disturbance ≥ grade 2
Any confusion ≥ grade 2
Any dizziness ≥ grade 3
Pulmonary
Any dyspnoea ≥ grade 2
Diagnosis of a new disease which requires discontinuation of the study agent or results in inability to continue to comply with Treatment procedures
The reason for withdrawal will be recorded in the CRF. If the participant is withdrawn due to an adverse event, the investigator will arrange for follow-up visits or telephone calls until the adverse event has resolved or stabilized. Upon removal from the study, patient will be followed for 14 days or until the AE or SAE is resolved (whichever is of longer duration).
Statistical Methodology
Standard linear regression techniques, descriptive statistics and graphical tools will be used to compare groups on other outcomes. Reporting of the severity and frequency of adverse events (NCI Common Terminology Criteria Version 3.0) related to the interventions will be conducted at the endpoint of the study. All treatment-related adverse events will be reported.
The statistical evaluation for both the primary and secondary outcome measurements will be performed using STATA version 11 and Microsoft Excel. Secondary analysis adjusting for potential confounders such as age, gender, BMI will also be performed. We will also evaluate if exploratory analyses and stratification show any evidence of trends. If promising trends are observed, then further studies will be pursued.
Potential Risks
Possible adverse effects related to administration of the study drug can include gastrointestinal effects such as nausea and heartburn. Other specific risks will be included in the consent form.
Potential Benefits
100% Amelioration or Total Elimination of all Parkinsonian Symptoms