Background and objectives Semisolid oral preparations (Avaleha) are used in Ayurvedic therapeutics. The problems with these preparations include a bitter taste and the use of a sugar base. Here, we aimed to modify the semisolid Vasavaleha (VA) preparation to an oral solution (syrup) and to observe the efficacy of the VA syrup on patients with bronchial asthma.
Methods VA syrup was prepared by dissolving the water-soluble extracts of Adhatoda vasica leaves and Piper longum fruits in purified water; sorbitol solution and honey were used as sweeteners. Organoleptic tests as well as pH, specific gravity, and viscosity measurements were performed. Liquid chromatography-mass spectrometry analysis of the VA syrup was carried out using an Agilent UHPLC-MS/Q-TOF (6545) system coupled with a Dual AJS ESI source. An open-label clinical trial of the VA syrup was performed on 13 patients with bronchial asthma at a dose of 10 mL (oral, twice a day) for 30 days.
Results The prepared VA syrup was brown in color and sweet in taste. The pH, specific gravity, and viscosity of the prepared VA syrup were 7.52, 1.10, and 1.922, respectively. Piperine, piperdardine, vasicine, vasicol, vasicinol, and vasicinone were determined to be the major phytochemical compounds. This preparation significantly improved all clinical symptoms of asthma and lung function test results in patients with bronchial asthma. It had mucolytic, bronchodilator, and anti-allergic properties. It had no adverse effects at the indicated dose.
Conclusions The oral solution (syrup) might be an effective alternative for Ayurvedic semisolid preparations. The VA syrup may be taken as an alternative for VA as it was found to be an effective formulation for the management of bronchial asthma.
Acknowledgments
None to declare.
Funding
The authors did not receive any funding for the present study.
Conflict of interest
The authors declare that there are no competing interests.
Author contributions
PKS conceived, designed and supervised the research. BN per-formed the clinical trial. SA and VR did the chemical analysis. PKS, SA and VR analysed the data. PKS wrote the original draft. SA and VR reviewed and edited the manuscript. All authors had read and agreed to the published version of the manuscript.
Ethical statement
Ethical approval was taken from the Institutional Ethics Commit-tee, J. B. Roy State Ayurvedic Medical College & Hospital (Ref. No. JBR/IEC/04/2019 dated 04/06/2019). The trial was conducted in accordance with the ethical guidelines of the Helsinki Declara-tion (as revised in 2013), and written informed consent was ob-tained from all patients prior to their enrollment.
Data sharing statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.
| [1] |
Bramhankar R, Baruah H, Munishwar N, Raghuveer. Insight into traditional dosage forms in Ayurveda in light of Ayurvedic pharma-ceutics. Int J Pharm Res 2021; 13(2):3925-3933. doi:10.31838/ijpr/2021.13.02.499.
|
| [2] |
Kaur J, Baghel DS, Singh S, Mittal A. Avaleha Kalpana (medicated semisolid preparation): an synoptic overview. Int J Res Anal Rev 2019; 6(1):591-599.
|
| [3] |
Dharmage SC, Perret JL, Custovic A. Epidemiology of Asthma in Children and Adults. Front Pediatr 2019;7:246. doi:10.3389/fped.2019.00246,PMID:31275909.
|
| [4] |
Nunes C, Pereira AM, Morais-Almeida M. Asthma costs and social impact. Asthma Res Pract 2017; 3:1. doi:10.1186/s40733-016-0029-3,PMID:28078100.
|
| [5] |
Do DC, Zhao Y, Gao P. Cockroach allergen exposure and risk of asth-ma. Allergy 2016; 71(4):463-474. doi:10.1111/all.12827,PMID:26706467.
|
| [6] |
Acharya YT ed. Chikitsa Sthana. Reprint ed. Charaka Samhitha of Agnivesha, Varanasi: Chaukhamba Surbharati Prakashana; 2011:535.
|
| [7] |
Mishra SN ed. Bhaishajya Ratnavali of Govind Das Sen. 20th ed. Varanasi: Chaukhambha Surbharti Prakashan; 2011:408.
|
| [8] |
Gohel SD, Anand IP, Patel KS. A comparative study on efficacy of Bha-rangyadi Avaleha and Vasa Avaleha in the management of Tamaka Shwasa with reference to childhood asthma. Ayu 2011; 32(1):82-89. doi:10.4103/0974-8520.85736,PMID:22131763.
|
| [9] |
Paneliya AM, Patgiri B, Galib R, Prajapati PK. Efficacy of Vasa Avaleha and its granules on Tamaka Shwasa (bronchial asthma): Open-label randomized clinical study. Ayu 2015; 36(3):271-277. doi:10.4103/0974-8520.182760,PMID:27313413.
|
| [10] |
Suryavanshi M, Meena HML, Babu G, Yadav B, Chaudhary S, Namburi URS, et al. Clinical efficacy and safety of “vasavaleha” in the man-agement of stable chronic bronchitis: a prospective open label mul-ticenter study. J Res Ayurvedic Sci 2017; 1(4):231-237. doi:10.5005/jp-journals-10064-0023.
|
| [11] |
Raina N. Clinical study of kantkari avleha and vasa avleha in the man-agement of Tamak Shwasa W.S. R to bronchial asthma. Int Ayurvedic Med J 2021; 1:2705-2713. doi:10.46607/iamj08p5022020.
|
| [12] |
Anonymous ed.The Ayurvedic Formulary of India, Part- I. 2nd ed. New Delhi: Ministry of Health and Family Welfare, Government of India; 2000:31.
|
| [13] |
Vázquez-Blanco S, González-Freire L, Dávila-Pousa MC, Crespo-Diz C. pH determination as a quality standard for the elaboration of oral liquid compounding formula. Farm Hosp 2018; 42(6):221-227. doi:10.7399/fh.10932,PMID:30381041.
|
| [14] |
Al-Achi A, Kanade AY. Determining sucrose concentration in syrup by pharmaceutical methods. Clin Pharmacol Biopharm 2019; 8(1):188.
|
| [15] |
Grembecka M. Sugar alcohols- their role in the modern world of sweet-eners: a review. Eur Food Res Technol 2015; 241:1-14. doi:10.1007/s00217-015-2437-7.
|
| [16] |
Bobiş O, Dezmirean DS, Moise AR. Honey and Diabetes: The Impor-tance of Natural Simple Sugars in Diet for Preventing and Treating Dif-ferent Type of Diabetes. Oxid Med Cell Longev 2018; 2018:4757893. doi:10.1155/2018/4757893,PMID:29507651.
|
| [17] |
Patel RK, Kanani RJ, Patel VR, Patel MG. Development and validation of HPTLC method for simultaneous quantification of vasicine and pip-erine in Vasavaleha. Int J Pharm Res 2010; 2(3):14-17.
|
| [18] |
Liu W, Wang Y, He DD, Li SP, Zhu YD, Jiang B, et al. Antitussive, expec-torant, and bronchodilating effects of quinazoline alkaloids (±)-vasi-cine, deoxyvasicine, and (±)-vasicinone from aerial parts of Peganum harmala L. Phytomedicine 2015; 22(12):1088-1095. doi:10.1016/j.phymed.2015.08.005, PMID:26547531.
|
| [19] |
Chaudry NT Narseen S, Ihsan I. Bronchial asthma; Effect of Adhatoda vasica on airways responsiveness with pulmonary function test. Prof Med J 2005; 12(3):327-330. doi:10.29309/TPMJ/2005.12.03.5131.
|
| [20] |
Bang JS, Oh DH, Choi HM, Sur BJ, Lim SJ, Kim JY, et al. Anti-inflamma-tory and antiarthritic effects of piperine in human interleukin 1beta-stimulated fibroblast-like synoviocytes and in rat arthritis models. Ar-thritis Res Ther 2009; 11(2):R49. doi:10.1186/ar2662,PMID:19327174.
|
| [21] |
Aswar U, Shintre S, Chepurwar S, Aswar M. Antiallergic effect of piperine on ovalbumin-induced allergic rhinitis in mice. Pharm Biol 2015; 53(9):1358-1366. doi:10.3109/13880209.2014.982299,PMID:25868617.
|
| [22] |
Bhardwaj RK, Glaeser H, Becquemont L, Klotz U, Gupta SK, Fromm MF. Piperine, a major constituent of black pepper, inhibits human P- glycoprotein and CYP3A4. J Pharmacol Exp Ther 2002; 302(2):645-650. doi:10.1124/jpet.102.034728,PMID:12130727.
|
| [23] |
Shehzad M, Yaqoob A, Ishaq S, Anwar S. Preclinical and post clinical studies on newly developed herbal cough syrup from Piper longum L. fruit. Hamdard Med 2020; 63(1):28-35.
|
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