Cleanse Drops Study Proposal
Evaluation of efficacy with alternative medicine for treatment of gallbladder and/or renal calculus with Cleanse Drops remedy.
Objective – to prove clinical utility of Cleanse Drops™ remedy for relieving symptoms of gallbladder (GBL) or/and kidney lithiasis (KL).
Population – 30 patients with GBL or KL.
Visits – Baseline, Week 4, Week 6
Sites – Single site Dr. Pokov’s Polyclinic (6821 Reisterstown Rd Su. 206; Baltimore M.D. 21215; Tel 410-358-9159; Fax 410-358-6350)
Methods: We will conduct History and Physical exam at baseline visit. Ultrasound exam of abdomen and retroperitoneal area -renal and urinary bladder to evaluate liver gallbladder, kidneys urinary bladder will be conducted. Laboratory tests will include CBC, CMP uric acid, U/A and urine crystals if clinically required.
Based on information obtained during initial clinical evaluation, 30 patients will enter the study. They will be provided with Cleanse Drops supplies and and advised on appropriate regimens in addition to proper diet, life stile modification, possible other medical treatments and interventions. Follow visit in 1 month, with control ultrasound of point of interest, evaluation of gallbladder motility. or/and kidney, following potential adjustment of treatment, with possible continuation of Cleanse Drops intake. Third and final for the study third visit will follow in 6 weeks.
Inclusion criteria - Patients with mild to moderate abdominal pain, gallbladder or renal calculus. Both males and females will be elidgible. Age frame will be between 18 and 75 y.o.
Exclusions - Patients treated with severe abdominal pain who needs surgical consult for possible intervention, drug or alcohol abuse, or creatinine > 4.0 mg/dl, Cleanse Drops, history
Time frame – Our site is already performing all necessary clinical and laboratory testing including ultrasound and other devices. Patient enrollment will not require IRB approval since since no new intervention or pharmaceutical agent. If approved, we will start collecting data immediately with the promise to deliver the final dataset no later than September 2015.
Publication – Planned. After completion of this open-label study, and dependent on the results we will summarise them in a paper with clarification of potential efficacy of Cleanse Drops to be published in major peer-reviewed Journal.
Budget - $10,000 for statistics and administration. No overheard. Cleanse Caps LLC will provide remedy when and if needed.
Summary – Low use of Cleanse Drops™ may be attributed to the lack of controlled clinical studies with the remedy. The largest unsolved mystery is whether or not there are clinically meaningful changes in patients with GBL or KL before and after remedy intake. Should we show positive trends, Cleanse Drops™ utilization will expand .
Pokov M.D. L. Ac.
6821 Reisterstown Rd Su. 206
Baltimore M.D. 21215