DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20205548

A prospective, open label, randomized-controlled study to evaluate the efficacy and safety of Herbovir syrup in mildly symptomatic COVID-19 patients

A. Gopal Rao, Shankar Achar Somashekar, Poorna Prasad, Manjunath Reddy Lekkala, Sreenivasa Hanumanthaiah, . Muralidhar

Abstract


Background: COVID-19 patients experience cytokine storm which cause pulmonary and extra-pulmonary complications. Effective antiviral and immune boosters are need of hour to treat COVID-19 as well as post COVID complications.

Methods: In this study involving mild COVID-19 we randomized 40 patients to receive a Herbovir syrup along with standard of care (SOC) or SOC alone in 1:1 ratio. We evaluated the benefits of Herbovir syrup by assessing clinical outcomes and improvement in immune markers (LDH, CRP, D-dimer).

Results: At the end of the study the immune markers in Herbovir group improved significant compared to control group. In patients who received Herbovir, LDH decreased from 334 U/l at baseline to 254 U/l at the end of treatment (p value <0.009), CRP decreased from 7.4 mg/l to 3.1 mg/l (p value=0.0171) and D-dimer decreased from 0.610 mg/l at baseline to 318 mg/l at the end of study (p value=0.001). TLC values did not go below normal range in Herbovir group whereas 8 patients in control group had low TLC at the end of study. Early recovery from COVID 19 symptoms was observed in >75% patients in Herbovir treated group.

Conclusions: Herbovir accelerated recovery of COVID-19 patients by early improvement in clinical symptoms and immune markers in this study and results clearly indicates that Herbovir syrup has antiviral, immune booster activity and has definitive role in the management of mild COVID-19 patients along with standard of care. (Funded by Venkat pharma. CTRI no. CTRI/2020/08/027041).


Keywords


COVID-19, Post COVID complications, Herbovir

Full Text:

PDF

References


WHO. WHO Coronavirus Disease (COVID-19) Dashboard Data. Global (Updated: 15th Nov 2020; cited on 15th Nov 2020.

WHO. WHO Coronavirus Disease (COVID-19) Dashboard Data. India (Updated: 15th Nov 2020; cited on 15th Nov 2020.

Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020;18(4):844-7.

Levi M, Poll T. Coagulation and sepsis. Thromb Res. 2017;149:38-44.

Singh P, Chakraborty P, He D, Mergia A. Extract Prepared from the Leaves of Ocimum Basilicum Inhibits the Entry of Zika Virus. Acta Virol. 2019;63(3):316-21.

Panraksa P, Ramphan S, Khongwichit S, Smith D. Activity of andrographolide against dengue virus. Antiviral Res. 2017;139:69-78.

Jayakumar T, Hsieh C, Lee J, Sheu J. Experimental and Clinical Pharmacology of Andrographis paniculata and Its Major Bioactive Phytoconstituent Andrographolide. Evid Based Complement Alternat Med. 2013;2013:846740.

Yimer E, Tuem K, Karim A, Ur-Rehman N, Anwar F. Nigella sativa L. (Black Cumin): A Promising Natural Remedy for Wide Range of Illnesses. Evid Based Complement Alternat Med. 2019;2019:1528635.

Tan W, Jaganath I, Manikam R, Sekaran S. Evaluation of Antiviral Activities of Four Local Malaysian Phyllanthus Species against Herpes Simplex Viruses and Possible Antiviral Target. Int J Med Sci. 2013;10(13):1817-29.

Guerra-Boone L, Alvarez-Román R, Salazar-Aranda R, Torres-Cirio A, Rivas-Galindo V et al. Antimicrobial and antioxidant activities and chemical characterization of essential oils of Thymus vulgaris, Rosmarinus officinalis, and Origanum majorana from northeastern México. Pak J Pharm Sci. 2015;28(1):363-9.

Weber ND, Andersen DO, North JA, Murray BK, Lawson LD, Hughes BG. In vitro virucidal effects of Allium sativum (garlic) extract and compounds. Planta Med. 1992;58(5):417-23.

Chang JS, Wang KC, Yeh CF, Shieh DE, Chiang LC. Fresh ginger (Zingiber officinale) has anti-viral activity against human respiratory syncytial virus in human respiratory tract cell lines. J Ethnopharmacol. 2013;145(1):146-51.

Jaime MFV, Redko F, Muschietti LV, Campos RH, Martino VS, Cavallaro LV. In vitro antiviral activity of plant extracts from Asteraceae medicinal plants. Virol J. 2013;10: 245.

Sachan S, Dhama K, Latheef SK, Samad HA, Mariappan AK, Munuswamy P et al. Immunomodulatory Potential of Tinospora cordifolia and CpG ODN (TLR21 Agonist) against the Very Virulent, Infectious Bursal Disease Virus in SPF Chicks. Vaccines (Basel). 2019;7(3):106.

Xiao AT, Tong YX, Gao C, Zhu L, Zhang YJ, Zhang S. Dynamic profile of RT-PCR findings from 301 COVID-19 patients in Wuhan, China: A descriptive study. J Clin Virol. 2020;127:104346.

Chai X, Hu L, Zhang Y, Han W, Lu Z, Ke A et al. Specific ACE2 expression in cholangiocytes may cause liver damage after 2019-nCoV infection. BioRxiv. 2020;1-13.

Pan L, Mu M, Yang P, Sun Y, Wang R, Yan J et al. Clinical Characteristics of COVID-19 Patients with Digestive Symptoms in Hubei, China: A Descriptive, Cross-Sectional, Multicenter Study. Am J Gastroenterol. 2020;115(5):766-73.

Henry BM, Santos de Oliveira MH, Benoit S, Plebani M, Lippi G. Hematologic, biochemical and immune biomarker abnormalities associated with severe illness and mortality in coronavirus disease 2019 (COVID-19): a meta-analysis. Clin Chem Lab Med. 2020;58(7).

Shi J, Li Y, Zhou X, Zhang Q, Ye X, Wu Z et al. Lactate dehydrogenase and susceptibility to deterioration of mild COVID-19 patients: a multicenter nested case-control study. BMC Med. 2020;18:168.

Tan W, Zhao X, Ma X, Wang W, Niu P, Xu W et al. A Novel Coronavirus Genome Identified in a Cluster of Pneumonia Cases Wuhan, China 2019-2020. China CDC Weekly. 2020;2(4):61-2.

Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395(10223):497-506.

Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y et al. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020;395(10223):507-13.

Qin C, Zhou L, Hu Z, Zhang S, Yang S, Tao Y et al. Dysregulation of Immune Response in Patients with Coronavirus 2019 (COVID-19) in Wuhan, China. Clin Infect Dis. 2020;71(15):762-8.

Khan S, Ali A, Shie H, Siddique R, Shabana, Nabif G et al. COVID-19: Clinical aspects and therapeutics responses. Saudi Pharmaceutical J. 2020;28(8);1004-8.

Ge H, Wang X, Yuan X, Xiao G, Wang C, Deng T et al. The epidemiology and clinical information about COVID-19. Eur J Clin Microbiol Infect Dis. 2020;1-9.

Lippi G, Mattiuzzi C, Bovo C, Plebani M. Current laboratory diagnostics of coronavirus disease 2019 (COVID-19). Acta Biomed. 2020;91(2):137-45.

Mishra Y, Pathak BK, Mohakuda SS, Sen S, Singh R, Singh AR. Relation of D-dimer levels of COVID-19 patients with diabetes mellitus. Diabetes Metab Syndr. 2020;14(6):1927-30.

Rostami M, Mansouritorghabeh H. D-dimer level in COVID-19 infection: a systematic review. Expert Rev Hematol. 2020;1-11.

Vidali S, Morosetti D, Cossu E, Luisi MLE, Pancani S, Semeraro V et al. D-dimer as an indicator of prognosis in SARS-CoV-2 infection: a systematic review. ERJ Open Res. 2020;6(2):00260-2020.

Yu H, QinC, Chen M, Wang W, Tian D. D-dimer level is associated with the severity of COVID-19. Thromb Res. 2020;195:219-25.

Heneka MT, Golenbock D, Latz E, Morgan D, Brown R. Immediate and long-term consequences of COVID-19 infections for the development of neurological disease. Alzheimers Res Ther. 2020;12(1):69.

Dasgupta A, Kalhan A, Kalra S. Long term complications and rehabilitation of COVID-19 patients. J Pak Med Assoc. 2020;70(3-5):S131-5.

Jiang DH, McCoy RG. Planning for the Post-COVID Syndrome: How Payers Can Mitigate Long-Term Complications of the Pandemic. J Gen Intern Med. 2020;35(10):3036-9.

Lee JK, Kwak BO, Choi JH, Choi EH, Kim JH, Kim DH. Financial Burden of Hospitalization of Children with Coronavirus Disease 2019 under the National Health Insurance Service in Korea. J Korean Med Sci. 2020;35(24):e224.