An Open Label Single Arm Clinical Study to Evaluate the Combined effect of Sadhyovamana, Gudadeepyaka and Nishottamadi Kashaya in the management of Sheetapitta vis-a-vis Urticaria.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Reduction of signs and symptoms like varatidamshtravat shotha, kandu, toda, daha, chardi, jwara.
研究概览
简要总结
Sheetapitta is a Tridoshaja Vyadhi (disease caused by the vitiation of all three doshas—Vata, Pitta, and Kapha) that manifests on the skin and affects individuals of all age groups. It is typically triggered by exposure to cold air or breeze, which aggravates Vata and Kapha doshas. These doshas then associate with Pitta dosha, resulting in various symptoms such as Varatidamshtravat Shotha (swelling resembling an insect bite), Kandu (itching), Toda (pricking pain), Daha (burning sensation), Chardi (vomiting), and Jwara (fever). Classical Ayurvedic texts like those of Madhavakara consider Sheetapitta and Udarda to be synonymous. The clinical features of Sheetapitta closely resemble those of urticaria.
Urticaria, in contemporary medicine, presents as transient skin lesions characterized by a central wheal surrounded by an erythematous halo or flare. These lesions are often pruritic (itchy) and typically last for about 24 hours. Urticaria is categorized as acute if it persists for less than six weeks and chronic if it continues for more than six weeks. It is a common condition, affecting approximately 15–20% of the population at some point in their lives. The peak incidence is observed during the third decade of life, and the condition tends to be more prevalent in females than in males.
According to Ayurveda, Sheetapitta (urticaria) requires immediate treatment due to its sudden onset. Sadhyovamana, a rapid cleansing procedure, is used without prior preparation to eliminate aggravated Kapha. Treatments like Abhyanga, Seka, Vamana, Virechana, Lepa, and Shamanoushadi are recommended, along with protocols for Kushta and Amlapitta. Gudadeepyaka, containing Pittaghna Guda and Kaphavatagna Ajamoda, and Nishottamadi Kashaya, indicated for skin disorders, may support effective management. This study evaluates the combined efficacy of Sadhyovamana, Gudadeepyaka, and Nishottamadi Kashaya in treating Sheetapitta.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects of all gender of age group between 18 to 50 years. 2.Subjects with the signs and symptoms of Sheetapitta vis-à-vis Urticaria will be included.
- •Subjects with Urticaria Activity score.
- •UAS 1-6 will be included.
- •Both fresh cases and treated cases of Sheetapitta vis-à-vis Urticaria will be included.
排除标准
- •Subjects diagnosed with Urticarial vasculitis, Tuberculosis, HIV, Viral infections, Carcinoma and other Skin infections will be excluded.
- •Subjects with Uncontrolled Diabetes Mellitus, Uncontrolled Hypertension, Renal disorders and or other systemic illness which might interfere with the course of treatment will be excluded.
- •Pregnant women and lactating mother will be excluded.
- •Subjects unfit for Sadhyovamana procedure will be excluded.
结局指标
主要结局
Reduction of signs and symptoms like varatidamshtravat shotha, kandu, toda, daha, chardi, jwara.
时间窗: 0th day,3rd day, 31st day
次要结局
- Improvememt in the scores of Urticaria Activity Score.(0th day,3rd day, 31st day)
研究者
Dr Megha M Pujari
Government Ayurveda Medical College and Hospital Mysuru