A randomized, double-blind, placebo-controlled clinical study to evaluate the effect of LN20189 (Spectramune) on immune function in healthy subjects

Name:  A randomized, double-blind, placebo-controlled clinical study to evaluate the effect of LN20189 (Spectramune) on immune function in healthy subjects. [Data on file]

Abstract:

Objectives: The primary objective was to evaluate the efficacy of a novel herbal composition LN20189 on immune function in healthy subjects. The secondary objective was to study the safety and tolerability of the study supplement by monitoring the vital signs and possibility of adverse events at each follow-up visit.

Methodology: This was a single center, proof of concept, randomized, double blind, placebo-controlled, parallel group study in healthy subjects. Forty (n = 40) healthy male and female subjects aged between 35 and 60 years with a Body Mass Index (BMI) of 22 – 29.9 kg/m2 subjects were provided with the investigational product and were requested to visit the site on Day 1 & Day 28. Investigational Product was administered as capsule of 500 mg of LN20189 or Placebo. One capsule daily in the morning after breakfast.

Criteria for evaluation: Efficacy variables were T-cell population, T cell subsets (CD4, CD8), NK cell count, Serum markers (IL-2, IFN-γ, and Total IgG), Hematological parameters, Immune function questionnaire.

Efficacy: The Mean±SD of T-cell population were increased by 72.48±10.27 and 79.29 ± 9.86 from 72.16 ±8.68 and 72.53 ± 5.41 in placebo and LN20189 groups respectively. At the end of the study significant change of T-cell population is observed in between groups. A significant Improvement of CD4+ T cells subset in T cell population is observed in between groups (P<0.05) and the Mean±SD were improved by 34.98±7.57 from 31.77±4.79 in LN20189 group. CD8+ T cells subset in T cell population reduced compared to baseline in both the groups. And the change from baseline was -1.84±6.38 and -1.75±4.53 in placebo and LN20189 respectively. Where in the CD4-CD8 ratio was significantly increased in LN20189 compare to placebo (P<0.05). The Mean±SD were by 1.10±0.18 and 1.28±0.26 in placebo and LN20189 groups respectively. In Natural killer (NK) cells count significantly increased in LN20189 group from baseline. The Mean±SD were 17.59±5.73and 20.35±6.69 in placebo and LN20189 groups respectively. At end of the study, statistically significant improvement in Interferon- γ (IFN- γ), and Total Immunoglobulin (IgG) levels were observed in between groups (P<0.05). In the, Immune function questionnaire (IFQ) score is improved in LN20189 group (2.75±3.06) (p=0.0002) when compared to placebo (9.00±6.24). In the Hematology the white blood cells and Lymphocytes levels in serum did not show any significance.

Conclusion: The results obtained from the study demonstrated that LN20189 significantly improved T-cell population in healthy subjects. Concurrently, the LN20189 supplemented participants showed improvement in CD4+ T cells subset, and CD4-CD8 ratio, Interferon- γ (IFN- γ), Total Immunoglobulin (IgG) levels and Immune function questionnaire (IFQ).