Razavi Journal of Medicine

Razavi Journal of Medicine

Efficacy and Safety of a Standardized Herbal Topical Formulation Containing Dorema ammoniacum for Mild to Moderate Plaque Psoriasis: A Randomized Double-Blind Placebo-Controlled Trial

Document Type : Original Article

Authors
1 Student Research Committee, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
2 Department of Dermatology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
3 Department of Pharmaceutical Sciences in Persian Medicine, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences. Mashhad, Iran
4 School of Food and Nutritional Sciences, University College Cork, Cork, Ireland
5 Department of Persian Medicine, School of Persian and Complementary Medicine Mashhad University of Medical Sciences
Abstract
Background: Psoriasis is a chronic inflammatory skin disease for which topical corticosteroids remain the most commonly used treatment; however, their long-term use may be limited by adverse effects and tachyphylaxis. In Persian medicine, Dorema ammoniacum (Oshaq) has been used for inflammatory skin conditions, suggesting a potential complementary therapeutic approach.

Objective :This study aimed to evaluate the efficacy and safety of a standardized topical formulation containing Dorema ammoniacum resin, vinegar, and wheat germ oil in patients with mild-to-moderate plaque psoriasis.

Methods: As the first double-blind, placebo-controlled randomized trial of this formulation, the study sought to provide high-quality clinical evidence using the Psoriasis Area and Severity Index (PASI) and the Dermatology Life Quality Index (DLQI) as validated outcome measures.

Results: For the intervention group, mean PASI score decreased significantly (P = 0.007) from 6.03 to 4.18 by week 8. The placebo group showed no significant change. At week 4 (P = 0.003) and week 8 (P < 0.001), between-group differences were significant. The intervention group's DLQI score decreased significantly (P ≤ 0.001) from 20.43 to 15.18 by week 8, and significant between-group differences were noted (P ≤ 0.001) favoring the intervention. No serious adverse events were noted.

Conclusion: The Oshaq-based topical formulation is significantly better than placebo. It improves the severity of mild-to-moderate plaque psoriasis and the quality of life of affected patients. Larger studies with extended follow-up and active comparators are needed to assess its therapeutic role further.
Keywords

Acknowledgments: This study was conducted as part of the PhD thesis of Dr. Zahra Naseri's PhD thesis at Mashhad University of Medical Sciences.

Data Availability Statement: The data that support the findings of this study are available from the corresponding author upon reasonable request.

Conflict of interest: The authors declare that they have no conflicts of interest.

Funding Sources: Mashhad University of Medical Sciences supported this study. The funder had no role in the design, data collection, data analysis, and reporting of this study.

Consent for publication: Written informed consent to publication (including images, personal and clinical details of the participant) was obtained from the patient.

Ethics approval and consent to participate: This study was conducted following the principles of the Declaration of Helsinki . The study protocol was reviewed and approved by the Research Ethics Committee of Mashhad University of Medical Sciences (approval number: IRMUMS.REC.1401.312). Written informed consent was obtained from all participants. This research has also been registered in the Iranian Registry of Clinical Trials under the code IRCT20220616055195N1.

Author contributions: Z.N.-P. and A.D. conceived and designed the study. M.J.Y. performed patient recruitment and dermatologic assessments. R.S. contributed to formulation development and pharmacologic supervision. H.H.M. designed and conducted the statistical analyses. All authors interpreted the data, revised the manuscript critically for important intellectual content, and approved the final version.

Open Access Policy: This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. To view a copy of this licence, visit https://creativecommons.org/licenses/by/4.0/

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