A CLINICAL STUDY TO EVALUATE COMPARATIVE CLINICAL EFFICACY AND SAFETY OF BHC9633CP TINOSPORA CORDIFOLIA IN IMMUNE SUPPORT ADULT SUBJECTS

Dr. Harish S.*, Savita Pawar, Madhu Krishnamani and Gaurav Soni

ABSTRACT

Background: Tinospora cordifolia commonly named as “Guduchi” in Sanskrit belonging to family Menispermaceae is a genetically diverse, large, deciduous climbing shrub with greenish yellow typical flowers, found at higher altitude. In racemes or racemose panicles, the male flowers are clustered and female are solitary. The flowering season expands over summers and winters. A variety of active components derived from the plant like alkaloids, steroids, diterpenoid lactones, aliphatics, and glycosides have been isolated from the different parts of the plant body, including root, stem, and whole plant. Recently, the plant is of great interest to researchers across the globe because of its medicinal properties like antimicrobial, immune booster, anti-diabetic, anti-periodic, anti-spasmodic, anti-inflammatory, anti-arthritic, anti-oxidant, anti-allergic, anti-stress, anti-leprotic, anti-malarial, hepatoprotective, immunomodulatory and anti-neoplastic activities. (Soham Saha et al. 2012). The aqueous extract of T. cordifolia has been shown to protect against Escherichia coli and Staphylococcus aureus infections. T. cordifolia enhances the phagocytic and intracellular bactericidal activities of macrophages and neutrophils against E. coli-induced peritonitis. It has been shown to control the drug-resistance Mycobacterium tuberculosis infection by inducing Th1 immune responses. The stem of T. cordifolia has been used as a constituent in many Ayurvedic and Unani preparations for the treatment of general debility, dyspepsia, fever, and urinary diseases. The stem is used as diuretic, stimulates bile secretion, and cures jaundice. The extract of the stem is also useful in skin diseases and in combination with other drugs act as an antidote to snakebite. The dry bark of T. cordifolia has been shown to possess antipyretic, antiallergic, anti-inflammatory, and antileprotic properties. Moreover, T. cordifolia has been shown to be effective against diabetes mellitus. (Sultan Alsuhaibani et al. 2017). Tinospora cordifolia extract is a potent immune booster has been suggested in the treatment of various microbial infections. Hence this clinical trial is conducted to evaluate the safety and efficacy of Tinospora cordifolia extract in healthy adult volunteers. Objectives: The objective of this clinical study to evaluate comparative clinical Efficacy and Safety of BHC9633CP Tinospora cordifolia in Immune Support Adult Subjects. Conclusion: The final results of this study showed that Tinospora cordifolia is orally safe and effective in boosting immunity in healthy subjects. This clearly indicates that Tinospora cordifolia has definitive role in the management of infections as an immune support.

Keywords: NK-T cells, Investigational Product, Tinospora cordifolia, Efficacy and Safety.