Assessing the efficacy and safety of Unani pharmacopoeial formulations in dermatophytosis (quba) – a randomized controlled trial

Saima Naseem; Mohammad Nawab; Syeda Hajra Fatima; Ahmed Minhajuddin; Asif Ahmad Khan

doi:10.1515/dmpt-2022-0125

Article

Assessing the efficacy and safety of Unani pharmacopoeial formulations in dermatophytosis (quba) – a randomized controlled trial

Saima Naseem , Mohammad Nawab , Syeda Hajra Fatima , Ahmed Minhajuddin and Asif Ahmad Khan

Published/Copyright: August 24, 2022

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From the journal Drug Metabolism and Personalized Therapy Volume 38 Issue 2

Abstract

Objectives

The recent trends of rising unresponsive cases of dermatophytosis to conventional therapies pose a challenge in clinical practice. Unani medicine offers effective treatment for dermatophytosis. This study aimed to evaluate the efficacy and safety of the Unani herbo-mineral preparations Qurs-e-Asfar (QA) and Rogan-e-Narjeel (RN) in dermatophytosis.

Methods

This was a randomized, active-controlled and open-label clinical study. The participants diagnosed with dermatophytosis (n=78) randomized into treatment group (n=40) receiving oral QA (778 mg twice a day) and topical RN and control group (n=38) receiving oral Itraconazole (100 mg/day) and topical Terbinafine hydrochloride (1%) for 6 weeks.

Results

We found post-treatment improvement in itching by 86.3% vs. 78% (treatment vs. control group), erythema by 96.4% vs. 94.3%, scaling by 93% vs. 92.2% and peripheral raised margins by 82.3% vs. 81%. Furthermore, this study showed that the differences in the mean Total Signs and Symptoms Score (TSSS) and positive KOH mount were clinically and statistically significant (p<0.05) in both the groups. On comparing inter group, the differences in mean TSSS (p=0.07) and positive KOH mount (p=0.717) were found statistically insignificant.

Conclusions

This study concludes that the formulations QA and RN were effective and safe in the treatment of dermatophytosis.

Keywords: dermatophytosis; Quba; Qurs-e-Asfar; Rogan-e-Narjeel; Unani formulations

Corresponding author: Mohammad Nawab, Department of Moalajat (Medicine), National Research Institute of Unani Medicine for Skin Disorders, Opp. ESI Hospital, Eragadda, Hyderabad 500032, India, E-mail: ccrumnawab@gmail.com

Acknowledgments

We are thankful to Director General, Central Council for Research in Unani Medicine, Ministry of AYUSH, Government of India, New Delhi for providing necessary financial support for this study.

Research funding: This study was sponsored by Central Council for Research in Unani Medicine, Ministry of AYUSH, Government of India, New Delhi, as an academic activity required for submission of post graduate dissertation.
Author contribution: Saima Naseem designed the study, developed protocol and case record form and conducted the study. Syeda Hajra Fatima examined pathological markers and KOH mount for skin scrapings. Ahmed Minhajuddin conceptualized the study. Asif Ahmad Khan drafted the manuscript. Mohammad Nawab developed protocol, evaluated the outcome, analysed the data and edited the manuscript.
Competing interest: Authors state no conflict of interest.
Informed consent: Informed consent was obtained from all individuals included in this study.
Ethical approval: This study was approved by the Institutional Ethics Committe and registered prospectively on 21/04/2020 in the Clinical Trial Registry-India (CTRI) under CTRI number-CTRI/2020/04/024765.
Data availability: The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

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Received: 2022-04-14

Revised: 2022-05-14

Accepted: 2022-05-30

Published Online: 2022-08-24

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Articles in the same Issue

https://doi.org/10.1515/dmpt-2022-0125

Keywords for this article

dermatophytosis; Quba; Qurs-e-Asfar; Rogan-e-Narjeel; Unani formulations