jrnls.org logo
Submit

BROWSE ALL JOURNALS

SEE ALL 19 JOURNALS
International Journal of Pharmaceutical InvestigationNOW IN
Article

Evaluation of Efficacy and Safety of ‘AHPL/AYTOP/2014A’ in Patients Suffering from Aphthous Ulcers - An Open Label, Randomized, Multi-center, Prospective, Active Controlled, Parallel Group, Clinical Study

Sanjay Nipanikar1★, Narendra Mundhe2, Vaishali Deshpande3, Nitin Shinde4, Mangesh Wakchaoure5, Pravin Ghadge6★ Corresponding author

  1. 1Ari Healthcare Pvt. Ltd., Pune, Maharashtra, INDIA.
  2. 2KVTR Ayurvedic College Boradi, Shirpur, Dhule, Maharashtra, INDIA.
  3. 3MAM’s SS Ayurveda Mahavidyalaya and Sane Guruji Aarogya Kendra, Malwadi, Hadapsar, Pune, Maharashtra, INDIA.
  4. 4Samhita Yog and Ayurevda Clinic, Hadapsar, Pune, Maharashtra, INDIA.
  5. 5Moraya Clinic, Alandi road, Bhosri, Pune, Maharashtra, INDIA.
  6. 6Sant Tukaram Hospital, Maan, Dist-Mulshi, Pune, Maharashtra, INDIA.

CORRESPONDENCE

Sanjay Nipanikar

Ari Healthcare Pvt. Ltd., Pune, Maharashtra, INDIA.

sanjay.n@arihealthcare.in

Received: 08-02-2021; Revised: 20-05-2021; Accepted: 18-06-2021.

Volume 11, Issue 2 · pp. 238–243 · PUBLISHED · DOI: 10.5530/ijpi.2021.2.42

View on IJPI original site ↗

ABSTRACT

Background:Aphthous stomatitis is a painful and often inflammatory condition. Objective of the study is to evaluate safety and efficacy of Arimu mouth ulcer gel (AHPL/ AYTOP/2014A) in subjects suffering from aphthous ulcers. Methods:This study compared effect of Arimu mouth ulcer gel (Group I), with sponsors other mouth ulcer gels (Group II, Group III), marketed Ayurvedic formulation (Group IV), and conventional preparation (Group V). Subjects were advised to apply given formulations twice daily for 14 days or till complete healing of ulcer whichever was earlier. Results:A total of 276 subjects completed the study. Statistically significant reduction in the mean pain score (VAS) was observed from first follow up visit and continued till the end of the study in all the groups. If compared, the reduction in the mean pain score was significantly more in Group I than Group II, Group III and Group IV and comparable to that of Group V on Day 3. On other follow up visits, change was comparable between the groups and the difference was not significant. The same trend had been observed for burning sensation. Onset of action was less and duration of action was longer in group I compared to other groups. The number of days required to heal ulcer was less in group I than other groups. Adverse events such as vomiting and fever occurred which were not related to study drugs and did not require discontinuation of the study treatment. Conclusion: Arimu mouth ulcer gel is safe and effective in treating aphthous ulcer.

KEYWORDS

Open in new tab

REFERENCES

As published

Showing references and in-text citations exactly as published.

    Cite this article

    SELECT FORMAT

    Nipanikar, S., Mundhe, N., Deshpande, V., Shinde, N., Wakchaoure, M., & Ghadge, P. (). Evaluation of Efficacy and Safety of ‘AHPL/AYTOP/2014A’ in Patients Suffering from Aphthous Ulcers - An Open Label, Randomized, Multi-center, Prospective, Active Controlled, Parallel Group, Clinical Study. International Journal of Pharmaceutical Investigation, 11(2), 238–243. https://doi.org/10.5530/ijpi.2021.2.42