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临床试验/CTRI/2024/11/076373
CTRI/2024/11/076373尚未招募2 期

A Comparative Clinical Study on the Efficacy of Arq-e-Shahetra orally and Mazo with Sirka vs Mirch e Siyah wa Safed with Cows Ghee Locally in Nar-e-Farsi (Eczema).

Government Unani Medical College & Hospital Bangalore-5600791 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年11月10日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
36
试验地点
1
主要终点
• Decrease in Eczema Area and Severity Index (EASI) score.

研究概览

简要总结

Eczema(Nar-e-Farsi) is a inflammatory skin condition, characterized by dry skin with itchy patches which typically flactuates between periods of remission and flares. According to Ibn Abi Sadique Nar-e-Farsi is named because Naar means Aag as a patient feel more irritation and burning sensation in those lesions, Farsi means it was more common among the people of Mulk Faras*( Persia)* or referred to the physician who treated Nar-e-Farsi first also was a resident of *Mulk Faras(Persia).*M H Qamri described Nar-e-Farsi as a type of itch related to very severe non bearable burning , it occurs in some organs with vesiculation and the vesicles are filled with Raqeeq Rutubat (Thin fluid), which is due to increase of Hiddat in *Khilt e Dam.*Akbar Arzani also described Nar-e-Farsi as a skin disease associated with vesicle formation , itching and burning.Nar-e-Farsi is a type of disease which occurs due to alteration in humors and specially Lateef Safravi Mawaad (light yellow bile) which are eliminated towards the skin and appear in the form of vesicles with severe itching and burning . Along with safra some ghaleez mawaad is also accumulated which is responsible for itching, burning and chronicity of disease and Lateef Mawad  is responsible for burning superficially .Eczema are classified into 3 groups based on etiology.

Endogenous Eczema : Constitutional factors predispose the patient to develop an eczema. Eg : Nummular dermatitis.

Exogenous Eczema : External stimuli triggers development of Eczema. Eg : Irritant dermatitis.

Combined Eczema : when a combination of constitutional factors and extrinsic triggers  are responsible for the development of eczema. Eg : Atopic Dermatitis.

Clinical features of eczema are divided into 3 stages .

Acute eczema is characterized by intense pruritus ,erythema, oedema , papules , vesicles , oozing ,crusting and even blister formation. In subacute Eczema there is diffused erythema, oedema, and scaling in this stage oedema, vesiculation and oozing components come down and lesion starts scaling.  Chronic Eczema presents with severe pruritus, erythema, oedema, hyperkeratosis and lichenification.The signs and symptoms of Eczema are assessed on the basis of eczema area and severity index EASI score  and patient oriented eczema measure POEM questionnair. This is more feasible in obtaining a quick and simple understanding of severity of disease and response to medication. A study recommends using EASI score with POEM Questionnaire to assess objective and subjective disease severity measurement.

In Unani system of medicine ,management of Nar-e-Farsi depends on various factors like environment, lifestyle, diet and family history of patient. First and  foremost predisposing and aggrevating factors should be eliminated, suitable changes in lifestyle and diet to be done and istefragh by means of Fasd and correction of  the Sue Mizaj is recommended. Drugs possessing properties like *Musaffi e Dam(blood purifier),Mujaffif(desiccative), Musakkin(soothing), Mubarrid(coolent), Muhallil(resolvant)*are indicated for the treatment of Nar-e Farsi like *Ushba , Shahetra , Sandal Safaid ,Chiraita ,Mundi ,Chobchini, Bisfaij , Kafoor , Raal , Kat Safaid , Gil-e-Armani , Mazo .*Based on above properties a Unani formulation of Arq-e-Shahetra  orally  and Zimaad of Mazo with Sirkaand Mirch e Siyah wa Safed with Cows Ghee locally are selected to evaluate there efficacy in Nar-e- Farsi.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients of age group between age
  • 60 years Patients of both genders Clinically diagnosed patients of eczema as per Hanifin and Rajika criteria Eczema of mild to moderate as per EASI score (≤29%) History of Eczema less than 5 Years.

排除标准

  • Patients with other skin diseases like psoriasis, lichen planus and active acute infections Patients with diabetes , sys Htn , malignancy , autoimmune and other systemic diseases Pregnant and lactating women Patients not willing to attend treatment schedule regularly.

结局指标

主要结局

• Decrease in Eczema Area and Severity Index (EASI) score.

时间窗: 0TH Day,15th Day,30th Day 45th Day of study. post | follow up on 60th day.

• Change in photographs of the lesion

时间窗: 0TH Day,15th Day,30th Day 45th Day of study. post | follow up on 60th day.

次要结局

  • •Decrease in Patient Oriented Eczema Measures (POEM) Questionnaire(0TH Day,15th Day,30th Day 45th Day of study. post)

研究者

发起方
Government Unani Medical College & Hospital Bangalore-560079
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Syed Shuaib Pasha

Government Unani Medical College and Hospital

研究点 (1)

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