Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Oct-Dec;13(4):100664.
doi: 10.1016/j.jaim.2022.100664. Epub 2022 Nov 24.

A prospective, single centre, open label, single arm pilot study to evaluate the efficacy and safety of Amlapitta Mishran Suspension in participants with endoscopic gastritis

Yashashri C Shetty  1 , Paresh G Koli  2 , Manoj Lahoti  3 , Savita Kulkarni  4 , Preeti Rajput  4 , Mukesh B Chawda  5
Affiliations

A prospective, single centre, open label, single arm pilot study to evaluate the efficacy and safety of Amlapitta Mishran Suspension in participants with endoscopic gastritis

Yashashri C Shetty et al. J Ayurveda Integr Med. 2022 Oct-Dec.

Abstract

Background: Endoscopic gastritis is associated with symptoms of gastritis, along with endoscopic findings. Amlapitta Mishran has multiple active components that act via various mechanisms in patients with gastritis symptoms. We planned to conduct this study to find out the efficacy and safety of Amlapitta Mishran in patients with endoscopic gastritis.

Objectives: To find out efficacy of Amlapitta Mishran in patient with endoscopic gastritis.

Materials and methods: This study was an open-label, prospective, single-center study. Thirty participants were recruited, and Amlapitta Mishran Suspension was given for 30 days. Blood investigations for safety were performed at baseline (Visit 1), on Visit 3 and Visit 4. Endoscopy was performed at baseline and Visit 4, and stomach erosion score was recorded. Amlapitta Symptom Rating Scale score, Postprandial Distress Syndrome (PPDS) score, and Epigastric Pain Syndrome (EPS) score were efficacy endpoints.

Results: Out of the 30 participants recruited, 28 participants completed the study. The median age of participants in the study was 26.50 years. A statistically significant (P<0.05) reduction was seen in endoscopy score at Visit 4 as compared to baseline (Visit 1) by Wilcoxon Signed Rank test. Amlapitta Symptom Rating Scale score, PPDS score, EPS score also exhibited significant reduction (P < 0.05) at Visit 3 and Visit 4 as compared to baseline by Friedman's test with post hoc analysis. No statistically significant reduction was seen in these scores from Visit 3 to Visit 4, except for the EPS score. At the end of Visit 4, 18 (64%) participants had an endoscopy score of 1 (no erosions). At the end of Visit 4, ≥ 50% improvement was seen in Amlapitta Symptom Rating Scale score in 27 (96%) participants, PPDS score improved by ≥ 50% in 25 (89%) participants, and EPS score improved by ≥ 50% in 26 (93%) participants. All safety variables including laboratory investigation were within the normal range in all visits.

Conclusion: Amlapitta Mishran Suspension effectively reduced endoscopic gastritis scores in the participants and reduced the symptoms of gastritis measured by the Amlapitta Symptom Rating Scale, PPDS, and EPS scores with no adverse events.

Keywords: Amlapitta; Ayurved; Gastritis; Gastroenterology.

PubMed Disclaimer

Conflict of interest statement

Conflict of interest Nil.

Figures

Fig. 1
Fig. 1
Patient enrollment flowchart.
See this image and copyright information in PMC

References

    1. Kashiwagi H. Ulcer and gastritis. Endoscopy. 2007;39:101–105. doi: 10.1055/s-2006-945108. - DOI - PubMed
    1. Chauhan G., Mahapatra A.K., Babar Kapoor A., Kumar A. Study on clinical efficacy of avipattikar choorna and sutasekhar rasa in the management of Urdhwaga Amlapitta. J Pharmaceut Sci Innovat. 2015;4:11–15. doi: 10.7897/2277-4572.0414. - DOI
    1. Meenakshi K., Vinteshwari N., Minaxi J., Vartika S. Effectiveness of Ayurveda treatment in Urdhwaga Amlapitta: a clinical evaluation. J Ayurveda Integr Med. 2021;12:87–92. doi: 10.1016/J.JAIM.2020.12.004. - DOI - PMC - PubMed
    1. Madisch A., Andresen V., Enck P., Labenz J., Frieling T., Schemann M. The diagnosis and treatment of functional dyspepsia. Deutsches Arzteblatt International. 2018;115:222–232. doi: 10.3238/arztebl.2018.0222. - DOI - PMC - PubMed
    1. Masuy I., Van Oudenhove L., Tack J. Review article: treatment options for functional dyspepsia. Aliment Pharmacol Ther. 2019;49:1134–1172. doi: 10.1111/apt.15191. - DOI - PubMed