{"title":"专利多羟基制剂对健康参与者的免疫调节作用：一项单盲、随机、安慰剂对照、探索性临床研究。","authors":"Suresh Khadke, Poonam Gupte, Akanksha Mourya, Amit Yadav, Sarika Mane, Asavari Joshi, Madhavi Mahajan, Manisha Mishra, Supriya Bhalerao","doi":"10.4103/picr.picr_100_22","DOIUrl":null,"url":null,"abstract":"<p><strong>Context: </strong>Clinical study for immunity.</p><p><strong>Aims: </strong>The present study aimed to assess the effect of proprietary polyherbal formulation (PPHF), labelled as Kofol immunity tablets (KIT) on innate and adaptive immune responses in healthy individuals, on the backdrop of COVID-19 pandemic.</p><p><strong>Settings and design: </strong>Single-blind, randomized, placebo-controlled, exploratory study in institutional setting.</p><p><strong>Materials and methods: </strong>Post Ethics Committee permission, screened healthy individuals of either sex aged 18-35 years were randomized to PPHF/Placebo for 2 months. Major assessment variables included peak expiratory flow rate (PEFR), questionnaire-based immune status, perceived stress, and quality of life (QOL) with immune-specific cell counts (CD4+, CD8+), cytokines (interferon gamma [IFN-γ], tumor necrosis factor-alpha [TNF-α], interleukin 10 [IL-10]), and oxidative stress in red blood cells (RBCs) (malondialdehyde (MDA), glutathione peroxidase [GPx]), done at day 60.</p><p><strong>Statistical analysis used: </strong>Mean ± standard deviation and paired/unpaired <i>t-</i>test for parametric data analysis while median (range) and Wilcoxon Rank sum test/Mann-Whitney test for nonparametric data analysis, were done. Categorical data was analyzed using Chi-square test. GraphPad InStat software, version 9 was used with <i>p</i> < 0.05, as the level of statistical significance.</p><p><strong>Results: </strong>Of 52 recruited, 28 individuals completed the study. PPHF significantly increased PEFR, improved immune status along with QOL compared to baseline. It also decreased perceived stress from moderate and severe grade to mild. Serum IFN-γ levels remained almost constant post-PPHF treatment. PPHF significantly decreased MDA and increased GPx in RBCs. Significant decrease and increase in TNF-α and IL-10, respectively, were seen in PPHF group. The safety parameters post-PPHF treatment remained within normal reference ranges.</p><p><strong>Conclusions: </strong>PPHF is an efficacious and safe formulation with immunomodulatory potential.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"14 3","pages":"130-138"},"PeriodicalIF":0.0000,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/9e/8d/PCR-14-130.PMC10405535.pdf","citationCount":"0","resultStr":"{\"title\":\"Immunomodulatory effect of a proprietary polyherbal formulation on healthy participants: A single- blind, randomized, placebo- controlled, exploratory clinical study.\",\"authors\":\"Suresh Khadke, Poonam Gupte, Akanksha Mourya, Amit Yadav, Sarika Mane, Asavari Joshi, Madhavi Mahajan, Manisha Mishra, Supriya Bhalerao\",\"doi\":\"10.4103/picr.picr_100_22\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Context: </strong>Clinical study for immunity.</p><p><strong>Aims: </strong>The present study aimed to assess the effect of proprietary polyherbal formulation (PPHF), labelled as Kofol immunity tablets (KIT) on innate and adaptive immune responses in healthy individuals, on the backdrop of COVID-19 pandemic.</p><p><strong>Settings and design: </strong>Single-blind, randomized, placebo-controlled, exploratory study in institutional setting.</p><p><strong>Materials and methods: </strong>Post Ethics Committee permission, screened healthy individuals of either sex aged 18-35 years were randomized to PPHF/Placebo for 2 months. Major assessment variables included peak expiratory flow rate (PEFR), questionnaire-based immune status, perceived stress, and quality of life (QOL) with immune-specific cell counts (CD4+, CD8+), cytokines (interferon gamma [IFN-γ], tumor necrosis factor-alpha [TNF-α], interleukin 10 [IL-10]), and oxidative stress in red blood cells (RBCs) (malondialdehyde (MDA), glutathione peroxidase [GPx]), done at day 60.</p><p><strong>Statistical analysis used: </strong>Mean ± standard deviation and paired/unpaired <i>t-</i>test for parametric data analysis while median (range) and Wilcoxon Rank sum test/Mann-Whitney test for nonparametric data analysis, were done. Categorical data was analyzed using Chi-square test. GraphPad InStat software, version 9 was used with <i>p</i> < 0.05, as the level of statistical significance.</p><p><strong>Results: </strong>Of 52 recruited, 28 individuals completed the study. PPHF significantly increased PEFR, improved immune status along with QOL compared to baseline. It also decreased perceived stress from moderate and severe grade to mild. Serum IFN-γ levels remained almost constant post-PPHF treatment. PPHF significantly decreased MDA and increased GPx in RBCs. Significant decrease and increase in TNF-α and IL-10, respectively, were seen in PPHF group. The safety parameters post-PPHF treatment remained within normal reference ranges.</p><p><strong>Conclusions: </strong>PPHF is an efficacious and safe formulation with immunomodulatory potential.</p>\",\"PeriodicalId\":20015,\"journal\":{\"name\":\"Perspectives in Clinical Research\",\"volume\":\"14 3\",\"pages\":\"130-138\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/9e/8d/PCR-14-130.PMC10405535.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Perspectives in Clinical Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.4103/picr.picr_100_22\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/5/22 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Perspectives in Clinical Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4103/picr.picr_100_22","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/5/22 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}
Immunomodulatory effect of a proprietary polyherbal formulation on healthy participants: A single- blind, randomized, placebo- controlled, exploratory clinical study.
Context: Clinical study for immunity.
Aims: The present study aimed to assess the effect of proprietary polyherbal formulation (PPHF), labelled as Kofol immunity tablets (KIT) on innate and adaptive immune responses in healthy individuals, on the backdrop of COVID-19 pandemic.
Settings and design: Single-blind, randomized, placebo-controlled, exploratory study in institutional setting.
Materials and methods: Post Ethics Committee permission, screened healthy individuals of either sex aged 18-35 years were randomized to PPHF/Placebo for 2 months. Major assessment variables included peak expiratory flow rate (PEFR), questionnaire-based immune status, perceived stress, and quality of life (QOL) with immune-specific cell counts (CD4+, CD8+), cytokines (interferon gamma [IFN-γ], tumor necrosis factor-alpha [TNF-α], interleukin 10 [IL-10]), and oxidative stress in red blood cells (RBCs) (malondialdehyde (MDA), glutathione peroxidase [GPx]), done at day 60.
Statistical analysis used: Mean ± standard deviation and paired/unpaired t-test for parametric data analysis while median (range) and Wilcoxon Rank sum test/Mann-Whitney test for nonparametric data analysis, were done. Categorical data was analyzed using Chi-square test. GraphPad InStat software, version 9 was used with p < 0.05, as the level of statistical significance.
Results: Of 52 recruited, 28 individuals completed the study. PPHF significantly increased PEFR, improved immune status along with QOL compared to baseline. It also decreased perceived stress from moderate and severe grade to mild. Serum IFN-γ levels remained almost constant post-PPHF treatment. PPHF significantly decreased MDA and increased GPx in RBCs. Significant decrease and increase in TNF-α and IL-10, respectively, were seen in PPHF group. The safety parameters post-PPHF treatment remained within normal reference ranges.
Conclusions: PPHF is an efficacious and safe formulation with immunomodulatory potential.
期刊介绍：
This peer review quarterly journal is positioned to build a learning clinical research community in India. This scientific journal will have a broad coverage of topics across clinical research disciplines including clinical research methodology, research ethics, clinical data management, training, data management, biostatistics, regulatory and will include original articles, reviews, news and views, perspectives, and other interesting sections. PICR will offer all clinical research stakeholders in India – academicians, ethics committees, regulators, and industry professionals -a forum for exchange of ideas, information and opinions.
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