A Randomized, Double Blind, Placebo Controlled, Crossover Study to Assess the Safety and Beneficial Effects of Cassia Tora Supplementation in Healthy Adults
Autor: | K V S Sarma, Thandlam Muneeswara Reddy, Sirpurkar Dattatreya Rao, Kambalachenu Dorababu, K.K. Reddy, Himavanth Reddy Kambalachenu |
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Rok vydání: | 2017 |
Předmět: |
Adult
Male Cassia tora medicine.medical_specialty Placebo-controlled study Cassia Placebo Gastroenterology chemistry.chemical_compound Young Adult Double-Blind Method Internal medicine Medicine Humans Dyslipidemias Pharmacology chemistry.chemical_classification Cross-Over Studies medicine.diagnostic_test business.industry Plant Extracts Glutathione peroxidase Repeated measures design General Medicine Middle Aged Crossover study Lipids Healthy Volunteers Treatment Outcome chemistry Female Glycated hemoglobin business Lipid profile |
Zdroj: | Reviews on recent clinical trials. 13(1) |
ISSN: | 1876-1038 |
Popis: | Objective The current clinical trial was aimed at evaluating the safety and beneficial effect of Cassia tora (C. tora) supplementation in healthy adults. Design A randomized, double blind, placebo controlled study with a crossover design was done on 60 healthy normal weight adults (age range: 20-55 yrs). The study consisted of 2 treatment phases of 24 weeks each with a washout period of 4 weeks between the phases. 30 subjects randomly allocated to the 'Placebo first' group and 30 to 'C. tora first' group and assigned to receive a dose of C. tora (330 mg) or matched placebo three times a day. Safety markers were measured at base line and at the end of both the treatment phases. Body mass index, blood pressure, fasting blood sugar, glycated hemoglobin, lipid profile and antioxidants were measured at baseline and at every three months interval. Repeated measures analysis was applied to assess the period and carryover effects of the drug over placebo on biochemistries. Results C. tora supplementation was well tolerated and no apparent changes were observed in safety markers. The net effect of C. tora in natural units over placebo was 0.83 [0.57, 1.09]- high density lipoprotein cholesterol; 27.63 [24.39, 30.88]- superoxide dismutase; 0.32 [0.28, 0.36]- catalase; 0.68 [0.56, 0.80]- glutathione peroxidase; 0.25 [0.22, 0.29]- glutathione s-transferase; 0.32 [0.29, 0.36]- glutathione and -1.08 [-1.63, -0.54]- low density lipoprotein cholesterol. Conclusion The findings advocate that C. tora supplementation is safe and beneficial in elevating high density lipoprotein cholesterol and antioxidants and hence advised for consumption. |
Databáze: | OpenAIRE |
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