Department of Moalajat (Medicine), National Research Institute of Unani Medicine for Skin Disorders, Opp. ESI Hospital, Eragadda, Hyderabad, 500038, India.
Department of Pathology, National Research Institute of Unani Medicine for Skin Disorders, Opp. ESI Hospital, Eragadda, Hyderabad, 500038, India.
J Ethnopharmacol. 2022 Nov 15;298:115603. doi: 10.1016/j.jep.2022.115603. Epub 2022 Aug 6.
Pityriasis Versicolor (PV) is a commonly encountered infection of the skin caused by Malassezia species. Despite effective conventional antifungal drugs, the prevention and treatment of PV remain a challenge. The Unani pharmacopoeial preparations Itrifal Hakim Ali (IHA) and Habb-e-Kalaf (HK) have been used in the treatment of PV for a long time. The Unani practitioners recommend these formulations for the successful treatment of PV in clinical practice.
This study aimed to evaluate the efficacy and safety of Unani formulations IHA (oral) and HK (topical) in the treatment of PV.
A single centre, randomized, active-controlled, parallel-group and open-label clinical study was carried out in the outpatient departments of the National Research Institute of Unani Medicine for Skin Disorders, Hyderabad, India. The participants diagnosed with PV of any gender aged between 18 and 60 years were randomized into the test group (n = 37) to receive oral IHA (10g/day) and topical HK and the active control group (n = 35) to receive oral Itraconazole (100 mg/day) and local Terbinafine (1%) for the period of 6 weeks. Of them, 30 participants in each group completed the duration of the protocol therapy. The outcome of this study was based on a per-protocol analysis of the data. The efficacy of the interventions was measured by post-treatment change in subjective clinical symptoms/signs, mean TSSS, IGA score, direct microscopy of fungal elements and DLQI. The dermal safety was assessed by Berger/Bowman Scoring Scale and systemic safety was evaluated by Urinalysis, haematological and biochemical parameters.
This study observed statistically and clinically significant post-treatment reduction in itching (test group vs. active control group; 73.4% vs. 89.1%), hypopigmentation (63.2% vs. 57.1%), hyperpigmentation (60% vs. 65.5%), and scaling (91.6% vs. 92.7%) (p < 0.001). The differences in mean TSSS (5.4 ± 0.63 vs. 5.60 ± 0.32), IGA score (2.07 ± 0.15 vs. 1.74 ± 0.08) and DLQI (9.6 ± 2.06 vs. 9.04 ± 2.7) were also found clinically and statistically significant (p < 0.001) in each group when compared baseline data to post-treatment. On inter-group comparison, the changes in mean TSSS and DLQI were not found statistically significant at p < 0.05. But, the change in the mean IGA score was significant (p = 0.03). Further, the mycological cure was observed in 100% and 76.7% of participants in the test group and the control group respectively. On comparing inter-group the effects of the interventions on direct microscopy were found statistically significant (p = 0.034). In addition, no significant change in urinalysis, biochemical and haematological parameters from baseline to post-treatment in each group was observed.
This study concluded that the test drugs (IHA and HK) were safe and effective in the treatment of PV. The oral (IHA) and local (HK) Unani formulations were tolerated well by all the participants The efficacy and safety of the IHA and HK were comparable to the standard drugs (Itraconazole and Terbinafine).
花斑癣（PV）是一种常见的皮肤感染，由马拉色菌引起。尽管有有效的常规抗真菌药物，但 PV 的预防和治疗仍然是一个挑战。顺势疗法药典制剂 Itrifal Hakim Ali（IHA）和 Habb-e-Kalaf（HK）长期以来一直用于 PV 的治疗。顺势疗法从业者建议在临床实践中使用这些制剂成功治疗 PV。
本研究旨在评估顺势疗法制剂 IHA（口服）和 HK（局部）治疗 PV 的疗效和安全性。
在印度海得拉巴国家顺势疗法皮肤病学研究所的门诊部进行了一项单中心、随机、活性对照、平行组和开放标签的临床研究。诊断为任何性别、年龄在 18 至 60 岁之间的 PV 患者被随机分为试验组（n=37），接受口服 IHA（10g/天）和局部 HK，以及活性对照组（n=35）接受口服伊曲康唑（100mg/天）和局部特比萘芬（1%）治疗 6 周。每组有 30 名参与者完成了协议治疗期。该研究的结果是基于对数据的方案分析。干预措施的疗效通过治疗后主观临床症状/体征、平均 TSSS、IGA 评分、真菌元素直接显微镜检查和 DLQI 的变化来衡量。皮肤安全性通过 Berger/Bowman 评分量表评估，全身安全性通过尿液分析、血液学和生化参数评估。
本研究观察到治疗后瘙痒（试验组与活性对照组；73.4%与 89.1%）、色素减退（63.2%与 57.1%）、色素沉着（60%与 65.5%）和脱屑（91.6%与 92.7%）（p<0.001）的统计学和临床显著降低。两组之间平均 TSSS（5.4±0.63 与 5.60±0.32）、IGA 评分（2.07±0.15 与 1.74±0.08）和 DLQI（9.6±2.06 与 9.04±2.7）的差异也具有临床和统计学意义（p<0.001），与基线数据相比，在治疗后。在组间比较中，平均 TSSS 和 DLQI 的变化在 p<0.05 时没有统计学意义。但是，IGA 评分的变化具有统计学意义（p=0.03）。此外，试验组和对照组分别有 100%和 76.7%的参与者获得了真菌学治愈。在比较组间干预措施对直接显微镜检查的影响时，发现具有统计学意义（p=0.034）。此外，在每个组中，从基线到治疗后尿液分析、生化和血液学参数均未发生显著变化。
本研究得出结论，试验药物（IHA 和 HK）在治疗 PV 方面是安全有效的。口服（IHA）和局部（HK）顺势疗法制剂被所有参与者耐受良好。IHA 和 HK 的疗效和安全性与标准药物（伊曲康唑和特比萘芬）相当。
