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A Randomized, Double Blind, Placebo Controlled, Crossover Study to Assess the Safety and Beneficial Effects of Cassia Tora Supplementation in Healthy Adults

[ Vol. 13 , Issue. 1 ]

Author(s):

Himavanth Reddy Kambalachenu, Thandlam Muneeswara Reddy, Sirpurkar Dattatreya Rao, Kambalachenu Dorababu, Kanala Kodanda Reddy* and K.V.S. Sarma   Pages 69 - 78 ( 10 )

Abstract:


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.

Keywords:

Adults, antioxidants, Cassia tora, crossover design, healthy human, lipids, randomized trial.

Affiliation:

Department of Biomedical Sciences, Sri Ramachandra University, Chennai-600116, Department of Medicine, Sri Venkateswara Medical College, Tirupati-517 507, A.P, Department of Shalya, Sri Venkateswara Ayurvedic Medical College, Tirupati-517 507, A.P, Sri Vidyaniketan College of Pharmacy, A. Rangampeta, Tiruapti- 517102, A.P, Department of Anthropology, Sri Venkateswara University, Tirupati-517502, A.P, Department of Statistics, Sri Venkateswara University, Tirupati-517502, A.P

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