Working Paper Article Version 2 This version is not peer-reviewed

Immunomodulatory Effect of Charak Immunity Tablets (CIT) On Healthy Participants: A Single Blind, Randomized, Placebo-Controlled, Exploratory Study

Version 1 : Received: 12 September 2021 / Approved: 13 September 2021 / Online: 13 September 2021 (11:49:57 CEST)
Version 2 : Received: 14 September 2021 / Approved: 14 September 2021 / Online: 14 September 2021 (14:43:16 CEST)

How to cite: Mourya, A.; Yadav, A.; Khadke, S.; Mane, S.; Joshi, A.; Gupte, P.; Mahajan, M.; Bhalerao, S. Immunomodulatory Effect of Charak Immunity Tablets (CIT) On Healthy Participants: A Single Blind, Randomized, Placebo-Controlled, Exploratory Study. Preprints 2021, 2021090207 Mourya, A.; Yadav, A.; Khadke, S.; Mane, S.; Joshi, A.; Gupte, P.; Mahajan, M.; Bhalerao, S. Immunomodulatory Effect of Charak Immunity Tablets (CIT) On Healthy Participants: A Single Blind, Randomized, Placebo-Controlled, Exploratory Study. Preprints 2021, 2021090207

Abstract

Immunity has become an important aspect of concern, as the spread of corona virus, is on the rise. The strategies to boost and modulate the immunity have therefore become need of the hour. The present study was carried out to evaluate the effect of Charak immunity Tablets (CIT) on innate and adaptive immune response in healthy individuals. It was a single-blind, randomized, placebo-controlled, exploratory study. After obtaining Ethics Committee permission, 36 healthy individuals of either sex aged 18-35 years with prior consent were recruited in the study. They were randomly divided into 2 groups to receive either CIT or Placebo in 2:1 ratio. Both the interventions were given in a dose of 1 tab (500 mg) twice daily. The assessment variables were vitals [temperature, pulse, and blood pressure], respiratory health [respiratory rate, oxygen saturation and peak expiratory flow rate], questionnaire based assessment of immune status, perceived stress and quality of life along with objective assessment of immunity [CD4+, CD8+ counts, Interferon gamma (IFN γ), Tumor necrosis factor alpha (TNF-α) and Interleukin 10 (IL-10)] as well as oxidative stress; [Malondialdehyde (MDA) and Glutathione peroxidase], which were assessed at fixed time points. Of 36 recruited participants, only 18 participants completed the study. CIT treated individuals showed a statistically significant improvement in respiratory health, quality of life, perceived stress and subjective immune status. There was a decrease in the levels of serum IFN γ on day 60 compared to baseline. TNF-α and IL-10, both estimated from supernatant of Peripheral Blood Mononuclear Cells (PBMCs) stimulated with lipopolysaccharide (LPS), showed a decrease and a significant increase respectively on day 60 compared to baseline in CIT group. Further, CIT significantly decreased MDA levels.The present study indicates that CIT is an effective and safe drug to boost immunity. However, our findings need to be confirmed in larger sample size using more specific immune parameters.

Keywords

CD4- CD8 counts; immunity; inflammation; oxidative stress; peak expiratory flow rate

Comments (1)

Comment 1
Received: 14 September 2021
Commenter: Supriya Bhalerao
Commenter's Conflict of Interests: Author
Comment: The study intervention and dosage paragraph & the conclusion part has been modified.
Study intervention and dosage- Both interventional drugs, CIT & Placebo were supplied by Charak Pharma Pvt. Ltd.  The size, color, shape and packaging of both CIT and Placebo were identical to avoid identification by participants.  Placebo was composed of maize starch as the main ingredient along with other constituents. Both the tablets, CIT & Placebo were administered in the dose, 1 tablet (~500 mg) twice a day after meals with water for a total duration of 2 months.

Conclusion- The study drug, CIT when administered for two months to healthy individuals significantly improved their immune status and quality of life with a statistically significant decrease in stress. Further, it reduced oxidative stress in their RBCs and enhanced antioxidant capacity. CIT treated individuals also demonstrated encouraging results in case of T cell activation and secretory cytokine levels, which needs to be explored further in larger sample size. There was no significant change seen in the safety parameters after CIT administration. Thus, our study has adequately documented immunomodulatory potential of CIT.
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