Immunomodulatory effect of Unani polyherbal formulation - Tiryaq Wabai in mild to moderate COVID-19 patients – A randomized placebo-controlled clinical trial
Background: The pathogenesis of COVID-19 includes an integrated immune-inflammatory response. Modulation of host immune responses against the SARS-CoV-2 virus might be effective therapeutic management. Various Unani formulations have an immunomodulatory effect. Objective: To explore the immunomodula...
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| Format: | Article |
| Language: | English |
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Elsevier
2024-03-01
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| Series: | Journal of Ayurveda and Integrative Medicine |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S0975947624000184 |
| _version_ | 1797221867461804032 |
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| author | Ansul Kumar Mohd Saif Khan Zeya Ul Haque Arpita Rai Mohammad Fazil Gulam Rabbani |
| author_facet | Ansul Kumar Mohd Saif Khan Zeya Ul Haque Arpita Rai Mohammad Fazil Gulam Rabbani |
| author_sort | Ansul Kumar |
| collection | DOAJ |
| description | Background: The pathogenesis of COVID-19 includes an integrated immune-inflammatory response. Modulation of host immune responses against the SARS-CoV-2 virus might be effective therapeutic management. Various Unani formulations have an immunomodulatory effect. Objective: To explore the immunomodulatory effect and safety of Unani polyherbal drug (Tiryaq Wabai) in COVID-19 patients. Materials and methods: The current study was a randomized placebo-controlled clinical trial that included 92 mild to moderate COVID-19 patients randomized into two groups. The Unani formulation Tiryaq Wabai (2 gm orally once a day) was used as an intervention for 45 days, while the control group received a placebo. Both groups received standard care treatment. The primary outcome was 50% increment in absolute lymphocyte count (ALC). The secondary outcome was 50% increment in mean lymphocyte percentage, CD4 cells, and CD8 cell count. The mean increase in all the above parameters has also been studied. Relevant statistical tests were used to analyze the effect. Results: A statistically significant improvement in a 50% increase in ALC (p-value, 0.004), lymphocyte percentage (p-value, 0.056), CD4 (p-value, 0.005), and CD8 cell count (p-value, 0.050) was reported. Also, a significant improvement in the mean value of the lymphocyte percentage (p-value 0.0007), ALC (p-value 0.0022), CD4 cell count (p-value 0.0025), and CD8 cell count (p-value 0.0093) was observed after the treatment. One adverse event of mild grade was reported in the placebo group. The analysis of safety parameters (LFT and KFT) was normal for both groups. Conclusion: In mild to moderate COVID-19 patients, Tiryaq Wabai effectively showed immunomodulatory activity by improving ALC count, lymphocyte percentage, CD4, and CD8 cell count. |
| first_indexed | 2024-04-24T13:12:15Z |
| format | Article |
| id | doaj.art-eb60b5955459497a91100efe826e6ca7 |
| institution | Directory Open Access Journal |
| issn | 0975-9476 |
| language | English |
| last_indexed | 2024-04-24T13:12:15Z |
| publishDate | 2024-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Journal of Ayurveda and Integrative Medicine |
| spelling | doaj.art-eb60b5955459497a91100efe826e6ca72024-04-05T04:40:01ZengElsevierJournal of Ayurveda and Integrative Medicine0975-94762024-03-01152100903Immunomodulatory effect of Unani polyherbal formulation - Tiryaq Wabai in mild to moderate COVID-19 patients – A randomized placebo-controlled clinical trialAnsul Kumar0Mohd Saif Khan1Zeya Ul Haque2Arpita Rai3Mohammad Fazil4Gulam Rabbani5Department of CTVS. Rajendra Institute of Medical Sciences (RIMS), Bariatu, Ranchi, 834009, IndiaDepartment of Critical Care Medicine, New Trauma Centre & Central Emergency. Rajendra Institute of Medical Sciences (RIMS), Bariatu, Ranchi, 834009, IndiaDepartment of CTVS. Rajendra Institute of Medical Sciences (RIMS), Bariatu, Ranchi, 834009, IndiaDepartment of Oral Medicine and Radiology, Dental Institute. Rajendra Institute of Medical Sciences (RIMS), Bariatu, Ranchi, 834009, India; Corresponding author. Department of Oral Medicine and Radiology, Dental Institute. Rajendra Institute of Medical Sciences (RIMS), Bariatu, Ranchi, Jharkhand, 834009, India.Hakim Ajmal Khan Institute of Literary and Historical Research in Unani Medicine, CCRUM, Jamia Millia Islamia Campus, New Delhi, 110025, IndiaMedical Officer. CHC-Karra, Khunti, Jharkhand, 835209, IndiaBackground: The pathogenesis of COVID-19 includes an integrated immune-inflammatory response. Modulation of host immune responses against the SARS-CoV-2 virus might be effective therapeutic management. Various Unani formulations have an immunomodulatory effect. Objective: To explore the immunomodulatory effect and safety of Unani polyherbal drug (Tiryaq Wabai) in COVID-19 patients. Materials and methods: The current study was a randomized placebo-controlled clinical trial that included 92 mild to moderate COVID-19 patients randomized into two groups. The Unani formulation Tiryaq Wabai (2 gm orally once a day) was used as an intervention for 45 days, while the control group received a placebo. Both groups received standard care treatment. The primary outcome was 50% increment in absolute lymphocyte count (ALC). The secondary outcome was 50% increment in mean lymphocyte percentage, CD4 cells, and CD8 cell count. The mean increase in all the above parameters has also been studied. Relevant statistical tests were used to analyze the effect. Results: A statistically significant improvement in a 50% increase in ALC (p-value, 0.004), lymphocyte percentage (p-value, 0.056), CD4 (p-value, 0.005), and CD8 cell count (p-value, 0.050) was reported. Also, a significant improvement in the mean value of the lymphocyte percentage (p-value 0.0007), ALC (p-value 0.0022), CD4 cell count (p-value 0.0025), and CD8 cell count (p-value 0.0093) was observed after the treatment. One adverse event of mild grade was reported in the placebo group. The analysis of safety parameters (LFT and KFT) was normal for both groups. Conclusion: In mild to moderate COVID-19 patients, Tiryaq Wabai effectively showed immunomodulatory activity by improving ALC count, lymphocyte percentage, CD4, and CD8 cell count.http://www.sciencedirect.com/science/article/pii/S0975947624000184COVID-19Randomized controlled trialUnaniTiryaq wabaiImmunomodulatory drugs |
| spellingShingle | Ansul Kumar Mohd Saif Khan Zeya Ul Haque Arpita Rai Mohammad Fazil Gulam Rabbani Immunomodulatory effect of Unani polyherbal formulation - Tiryaq Wabai in mild to moderate COVID-19 patients – A randomized placebo-controlled clinical trial Journal of Ayurveda and Integrative Medicine COVID-19 Randomized controlled trial Unani Tiryaq wabai Immunomodulatory drugs |
| title | Immunomodulatory effect of Unani polyherbal formulation - Tiryaq Wabai in mild to moderate COVID-19 patients – A randomized placebo-controlled clinical trial |
| title_full | Immunomodulatory effect of Unani polyherbal formulation - Tiryaq Wabai in mild to moderate COVID-19 patients – A randomized placebo-controlled clinical trial |
| title_fullStr | Immunomodulatory effect of Unani polyherbal formulation - Tiryaq Wabai in mild to moderate COVID-19 patients – A randomized placebo-controlled clinical trial |
| title_full_unstemmed | Immunomodulatory effect of Unani polyherbal formulation - Tiryaq Wabai in mild to moderate COVID-19 patients – A randomized placebo-controlled clinical trial |
| title_short | Immunomodulatory effect of Unani polyherbal formulation - Tiryaq Wabai in mild to moderate COVID-19 patients – A randomized placebo-controlled clinical trial |
| title_sort | immunomodulatory effect of unani polyherbal formulation tiryaq wabai in mild to moderate covid 19 patients a randomized placebo controlled clinical trial |
| topic | COVID-19 Randomized controlled trial Unani Tiryaq wabai Immunomodulatory drugs |
| url | http://www.sciencedirect.com/science/article/pii/S0975947624000184 |
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