A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of Arq-i-Shahtara and topical Unani Formulation in the Management of Nar Farsi (Eczema)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assessment of Efficacy: Clinical assessment will be done at baseline visit and at each follow-up visit 2nd, 4th and 6th weeks and the assessment of response to treatment will be made on the basis of the change in EASI Score from baseline to the end of treatment, i.e., 6 weeks of therapy. For the efficacy of the test drug, 25% change in appearance and symptomatic relief will be considered significant.
研究概览
简要总结
Eczema, known as Nar Farsi in Unani medicine, is a chronic inflammatory skin disorder characterized by severe itching, erythema, scaling, and vesiculation. The prevalence of contact dermatitis in dermatology OPDs is estimated to be 4.38%, with higher rates in urban populations. It is most commonly seen in the 41–50 age group, with females being more affected in urban areas.
Conventional therapies such as glucocorticoids and immunosuppressants provide symptomatic relief but have multiple side effects, including fragile skin, easy bruising, telangiectasis, osteoporosis, hyperglycemia, muscle weakness, delayed wound healing, and increased susceptibility to infections.
The Unani system of medicine has traditionally used single and compound drugs for eczema management, but many of them have not been scientifically evaluated. This Randomized, Parallel Group, Open Label, Active Controlled Clinical Study is designed to assess the safety and efficacy of Arq-i-Shahtara (Fumaria parviflora Lam.) and a Topical Unani Formulation in managing Nar Farsi (Eczema).
Participants meeting the inclusion criteria will be randomly assigned to either the test group (receiving Arq-i-Shahtara and a Unani topical formulation) or the control group (receiving Levocetirizine and 0.05 Clobetasol propionate). The study will evaluate clinical improvements, quality of life, and safety parameters over a 6-week treatment period at NRIUMSD, Hyderabad.
This study aims to provide scientific validation for Unani treatments in eczema management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •The participants will be included in the study on the basis of the following criteria:
- •Participants of any gender between eighteen to sixty-five years of age.
- •Participants having the following any signs and symptoms of disease like Itching, Erythema, Visible flexural eczema, Excoriation, Hyperpigmentation, Burning sensation, Lichenification, Crusting, Dry skin.
- •Participants who are able and willing to comply with the protocol and to sign ICF.
- •Chronicity of more than six months and less than two years.
排除标准
- •The following patients will be excluded:
- •Participants aged Less than eighteen years and more than sixty-five years.
- •Known cases of significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction, Malignancy, HIV infection, AIDS, etc.
- •Any other clinical condition that in the opinion of the investigator would compromise the patient safety or successful participation in the trial.
- •Pregnancy and Lactation.
- •Known allergy, sensitivity or intolerance to the study drug or any of its ingredients.
- •Participants with active alcohol intake and/or drug abuse.
- •Participants not willing to sign the ICF and to attend treatment schedule regularly.
结局指标
主要结局
Assessment of Efficacy: Clinical assessment will be done at baseline visit and at each follow-up visit 2nd, 4th and 6th weeks and the assessment of response to treatment will be made on the basis of the change in EASI Score from baseline to the end of treatment, i.e., 6 weeks of therapy. For the efficacy of the test drug, 25% change in appearance and symptomatic relief will be considered significant.
时间窗: 6 weeks
次要结局
- Photographic Assessment: Digital photography of all lesions will be done using conditions (fixed room, fixed lighting and fixed camera settings) at baseline and 6th week.(6 weeks)