An open label, single arm clinical study to evaluate the combined effectiveness of navakashaya and vidangadi lepa in vicharchika (Dermatitis).
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.Itching sensation ( Kandu)
研究概览
简要总结
Vicharchika is a type of kshudra kushta. It is characterized by, kandu (itching sensation), Bahu Srava (excessive exudation), Shyava Varna (blackish brown discoloration) and Pidaka (Papule).It is similar to Dermatitis (eczema), which refers to a heterogeneous group of disorders that share similarities in clinical appearance and histopathologic findings, but may have different etiologies. Acute dermatitis often appears vesicular (like water boiling on the skin), whereas chronic dermatitis may be red, scaly, and lichenified. Pruritus is a common symptom of all types of dermatitis.
Dermatitis was estimated to affect 245 million people globally in 2015, or 3.34% of the world population. About 10-20% of the general practice includes the patients suffering from skin disorders and Eczema accounts for a very large proportion of all the skin diseases. According to Acharya Charaka, vicharchika is characterized by skin manifestation having the lakshanas kandu, pidaka, shyava Varna and bahu srava. Acharya Charka mentioned the predominance of kapha dosha in vicharchika.
This study is intended to evaluate the effectiveness of Navakashayainternally, indicated in kushta chikista and Vidangadi Lepa externally. Ingredients of Navakashya possess tikta rasa, laghu ruksha guna, ushna virya, katu vipaka, kushtagna properties which are opposite to the qualities of kapha. The external treatment Vidangadi lepa has properties like tikta rasa, laghu ruksha guna and kushtagna. The ingredients of both formulations are easily available. There are many shamana oushadies explained in the management of vicharchika, but there is still a need for an effective formulation. Hence this study aims at evaluating the combined effectiveness of Navakashaya internally 30 ml thrice daily, before food and Vidangadi Lepa externally once daily in day time for a period of 30 days in vicharchika. Subjects will be followed on 15 th and 30th days of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Subjects suffering with Vicharchika up to 1 year of chronicity
- •Subjects of either gender, aged between 18-70 years
- •Subjects willing to participate in the study and ready to sign informed consent form.
排除标准
- •Subjects with uncontrolled diabetes mellitus
- •Pregnant and lactating women
- •Subjects with impaired cardiac, renal, and hepatic functions.
结局指标
主要结局
1.Itching sensation ( Kandu)
时间窗: 30 days
2.Blackish brown discoloration (Shyava Varna)
时间窗: 30 days
3.Papule (Pidaka)
时间窗: 30 days
4. Excessive exudation (Bahu Srava )
时间窗: 30 days
EASI scale
时间窗: 30 days
次要结局
- QUALITY OF LIFE(30 days)
