Fifatrol, An Ayurvedic Formulation- A Prospective Multi-Center Observational  Study On The Symptoms of Upper Respiratory Tract Infections

Santosh Kumar Verma; Abdul Haye; Shubham Saxena; Mohammad Junaid; Mukesh Chandra Sharma

doi:10.48165/

Authors

Santosh Kumar Verma Faculty of Pharmaceutical Sciences, Motherhood University, Roorkee, Uttarakhand, India Author
Abdul Haye Independent Researcher Author
Shubham Saxena Institute of Management Technology, Ghaziabad, Uttar Pradesh, India Author
Mohammad Junaid Uttaranchal Ayurvedic College, Dehradun, Uttarakhand, India Author
Mukesh Chandra Sharma Faculty of Pharmaceutical Sciences, Motherhood University, Roorkee, Uttarakhand, India Author

DOI:

https://doi.org/10.48165/

Keywords:

URTI, Fifatrol, Polyherbal formulation, Post-marketing observational study

Abstract

Background: Upper respiratory tract infections (URTI) is a leading cause of economic burden as it remains among the top 3 diagnosed diseases globally with an estimated annual cost above $22 billion. Available medications to treat URTI and associated symptoms are effective, however, their tolerability remains a challenge for the practitioners. Recently, the use of alternative and complementary therapy has increased for the management of URTI symptoms. Fifatrol is an ayurvedic formulation for the management of URTI and its associated symptoms. However, its evidence-based data is limited. Therefore, this observational study was aimed to investigate the effects and to assess the safety of Fifatrol on URTI symptoms. Method: A post-marketing prospective observational study was carried out in the various cities of India. Patients enrolled in the study were presented with the symptoms of URTI in the health care centers and prescribed Fifatrol in twice-daily dose by the practitioners voluntarily. Symptoms of URTI (local, general, total) were collected on a 0–7 Likert scale at three-time points within 1 week (1st day, 4th day, and 7th day), using a questionnaire. Effectiveness was evaluated by examining the reduction in symptoms scores at day 4 and 7 respectively from baseline (day 1) Results: The mean score of local symptoms was 19.49 (SE: 0.39) on the day 1, dropping to 6.82 (SE: 0.14) and 1.84 (SE: 0.04), showing a decrease of 65.0% and 90.55% on the 4th and 7th day respectively (p < 0.001). The mean score of general symptoms reduced from 8.06 (SE: 0.26) on day 1 to 1.62 (SE: 0.5) and 0.8 (SE: 0.03), revealing a reduction of 79.9% and 90.11% on the 4th and 7th day respectively (p < 0.001). The mean total score of symptoms reduced from 28.34 (SE: 0.59) on day 1 to 8.63 (SE: 0.15) and 2.73 (SE: 0.05), indicating a decrease by 69.5% and by 90.36% on the 4th and 7th day respectively (p < 0.001). 1.97% adverse events of mild intensity reported during the observation period. Conclusions: This observational study has gathered evidence about the effectiveness and safety of Fifatrol on the amelioration of the symptoms of URTI.

Downloads

Download data is not yet available.

References

Jain N, Lodha R, Kabra S. Upper respiratory tract infections. The Indian Journal of Pediatrics. 2001 Dec;68(12):1135-8.

Fendrick AM, Monto AS, Nightengale B, Sarnes M. The economic burden of non influenza-related viral respiratory tract infection in the United States. Arch Intern Med. 2003 Feb 24;163(4):487-94.

Arroll B. Common cold. BMJ Clin Evid. 2008 Jun 09;2008

Winther B, Gwaltney JM, Mygind N, Hendley JO. Viral-induced rhinitis. Am J Rhinol. 1998 Jan-Feb;12(1):17-20.

Simasek M, Blandino DA. Treatment of the common cold. Am Fam Physician. 2007 Feb 15;75(4):515-20.

Adams PF, Hendershot GE, Marano MA., Centers for Disease Control and Prevention/National Center for Health Statistics. Current estimates from the National Health Interview Survey, 1996. Vital Health Stat 10. 1999 Oct;(200):1-203

Irwin RS, Baumann MH, Bolser DC, Boulet LP, Braman SS, Brightling CE, Brown KK, Canning BJ, Chang AB, Dicpinigaitis PV, Eccles R, Glomb WB, Goldstein LB, Graham LM, Hargreave FE, Kvale PA, Lewis SZ, McCool FD, McCrory DC, Prakash UBS, Pratter MR, Rosen MJ, Schulman E, Shannon JJ, Hammond CS, Tarlo SM. Diagnosis and management of cough executive summary: ACCP evidence-based clinical practice guidelines. Chest. 2006 Jan;129(1 Suppl):1S 23S.

Fashner J, Ericson K, Werner S. Treatment of the common cold in children and adults. Am Fam Physician. 2012 Jul 15;86(2):153-9.

Douglas RM, Hemilä H, Chalker E, Treacy B. Vitamin C for preventing and treating the common cold. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD000980.

Singh N, Mrinal PS, Gupta VK. A Review on Pharmacological Aspects of Achyranthes Aspera. Int J Pharmacogn Chinese Med. 2019;3(4):000188.

Sharma M, Mandal SK, Sharma C, Rai S, More A. Ayurvedic management of moderate COVID-19 infection: A case report. Journal of Ayurveda Case Reports. 2020 Apr 1;3(2):46.

Sheokand A, Sharma A, Gothecha VK. International Journal of Ayurvedic and Herbal Medicine 2: 3 (2012) 423: 426.

Thakur V. Evaluation of acute toxicity of Tribhuvana-Mishrana in albino rats. International Journal of Green Pharmacy (IJGP). 2018 May 18;12(01).

Conti B, Bartfai T, Lammert E, Zeeb M. Introduction to Fever. Metabolism of Human Diseases: Organ Physiology and Pathophysiology. 2014 Jun 2:313.

WHO, Traditional medicine in Asia, 11, 2011 16. Zhu YP. Chinese materia medica: chemistry, pharmacology and applications. CRC press; 1998 May 28.

Huang KC. The pharmacology of Chinese herbs. CRC press; 1998 Jul 27.

Venkatrao PU. Research Article International Ayurvedic Medical Journal ISSN: 2320 5091. 19. Upadhyay AK, Kumar K, Kumar A, Mishra HS. Tinospora cordifolia (Willd.) Hook. f. and Thoms.(Guduchi)–validation of the Ayurvedic pharmacology through experimental and clinical studies. International journal of Ayurveda research. 2010 Apr;1(2):112. 20. Khan AU, Rahim A, Iqbal Z, Gilani AH. Insights into mechanisms underlying the gut and airways modulatory effects of Swertia chirata. Journal of natural medicines. 2012 Jan;66(1):140-8.

Singh N, Mrinal PS, Gupta VK. A Review on Pharmacological Aspects of Achyranthes Aspera. Int J Pharmacogn Chinese Med. 2019;3(4):000188.

Choudhary S, Kaurav H, Madhusudan S, Chaudhary G. Daruharidra (Berberis aristata): Review based upon its Ayurvedic Properties. International Journal for Research in Applied Sciences and Biotechnology. 2021 Mar 24;8(2):98-106.

Zahiruddin S, Khan W, Nehra R, Alam MJ, Mallick MN, Parveen R, Ahmad S. Pharmacokinetics and comparative metabolic profiling of iridoid enriched fraction of Picrorhizakurroa–An Ayurvedic Herb. Journal of ethnopharmacology. 2017 Feb 2;197:157- 64.

World Health Organization. Quality assurance of pharmaceuticals: A compendium of guidelines and related materials. Good manufacturing practices and inspection. World Health Organization; 2007.

Anastasaki M, Bertsias A, Pirintsos SA, Castanas E, Lionis C. Post-market outcome of an extract of traditional Cretan herbs on upper respiratory tract infections: a pragmatic, prospective observational study. BMC complementary and alternative medicine. 2017 Dec;17(1):1-5.