Clinical Studies on Patients
Many controlled clinical trials were conducted at different centres to evaluate the clinical efficacy of Lipotab in hypercholesteremic and hyperlipidemic patients. For treatment of patients, the internationally accepted break off point; cholesterol
200 mg/ dl32 and above was followed for labeling a patient hypercholesteremic.
One such study was conducted at Christian Medical College, Ludhiana. Before treatment the ranges of cholesterol and HDL were observed as 451-260 and
60-17 (mg/dl) respectively. These investigations were repeated after 4 weeks and 6 weeks treatment. The statistical data showed that the mean effect of Lipotab is statistically significant after 4 weeks and after 6 weeks treatment in lowering the level of cholesterol (P < .01)**, (P< .001)*** respectively and increasing the amount of HDL (P< .05). In another study of Lipotab, the mean cholesterol and triglycerides level were 277.50 and 179.18 (mg%) respectively. After 1-3 months of treatment the results were highly significant. The mean cholesterol and triglycerides were observed as 230.73 (P< .001) and 154.49 (mg%) (P< .001) respectively.
A double blind clinical study was conducted at Majeedia Hospital, Jamia Hamdard, New Delhi. A total 100 patients were enrolled in the study. On completion of the study on patients receiving the coded drugs either Lipotab (drug) or Placebo, the use of the drug or placebo was decoded. The findings (patients taking Lipotab) were highly significant and did not impair physical safety indicators such as pulse rates or blood pressure. Laboratory safety indicators e.g. kidney function test (blood urea, serum creatinine), Liver function
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