1. EVALUATION OF EFFECTS OF SWAMALA (FORTIFIED CHYAWANPRASH) ON IMMUNITY AND QUALITY OF LIFE IN HEALTHY HUMAN VOLUNTEERS: AN OPEN LABELLED, RANDOMIZED, CONTROLLED EXPLORATORY STUDY.
- Author
-
Kurle, Dnyaneshwar G., Marathe, Padmaja A., S. T., Vignesh, Harit, Mahesh Kumar, Pawar, Vinay, Chitrakar, Mrudul, Bhapkar, Vedvati, Narvekar, Sangam, Nalawade, Megha, Chawda, Mukesh B., and Parhe, Ajinkya
- Subjects
- *
QUALITY of life , *CD4 lymphocyte count , *VOLUNTEERS , *VOLUNTEER service , *IMMUNITY - Abstract
Background: The immune system defends against invading pathogenic microorganisms and cancer. Ayurved interventions can restore immune functions. Swamala is an ayurvedic formulation containing Chyawanprash fortified with processed gold, silver, mica, coral, iron, etc. The study was planned to assess the effect of Swamala on immune functions and Quality of Life in healthy volunteers. Methods: A prospective, randomized, open-label, parallel arm, single-centre exploratory clinical study was conducted involving thirty-two healthy volunteers. They were randomly assigned to the Swamala Group (n=21) or Control Group (n=11) after conducting haematological, biochemical, X-ray, ECG, urine routine & immunological (IgG, TNF- α, CD4 cell count, anti-COVID antibody) investigations along with Quality of Life (QoL) assessment. Participants in the Swamala group were instructed to consume two teaspoonfuls (10 grams) of Swamala twice daily for 90 days. Control group participants did not receive any treatment. Weekly follow-up was done by means of telephonic interviews, and blood investigations were repeated after 45 & 90 days. Results: Swamala group showed significant improvement in CD4 cell count, neutrophils, platelets & quality of life scores, and significant reduction in TNF-α levels & eosinophil counts during the subsequent follow-up visits (p<0.05). Incidence of general illness (80% vs. 35%), and absenteeism (30 % vs. 0) were higher in the control group during the treatment period. The control group showed significant decrease in IgG levels and an increase in CRP levels during follow-up (p<0.05); no such variations were observed in the Swamala group. However, all the changes observed were within the physiological range. Swamala was found to be well-tolerated and safe. Conclusion: The current exploratory pilot study findings suggest that Swamala possesses potential immunostimulant and anti-inflammatory properties. [ABSTRACT FROM AUTHOR]
- Published
- 2023