A Controlled clinical study to evaluate efficacy of Virechana karma followed by Kakoudumbarikadi Kashaya along with Avalgujabijadi lepa in Shwitra (Vitiligo)
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
- 1
研究概览
简要总结
A Controlled Clinical Study To Evaluate The Efficacy Of Virechana Karma followed By Kakoudumabarikadi kashaya Along With Avalgujabijadi Lepa In Shwitra (Vitiligo) in adults of age group 18-60 years for a period of 30 days. During this study period 30 subjects diagnosed with SHWITRA (VITILIGO) will be recruited and divided into two groups, Group A (Trial drug/Intervention group) and Group B (Control drug/Comparator group) 15 subjects in each group respectively. Group A (Trial drug/Intervention group) it includes 15 subjects qualifying inclusion criteria of the current study will be administered Virechana as Shodhana karma followed by Kakoudumbarikadi Kashaya as Shamana Yoga along with Avalgujabijadi Lepa as an external application for 15 days starting from day-01 of trial, assessment of the patient during trial Before treatment, After Virechana Krama, After 15 days of Shamanayoga, Follow up after 45th day. Group B (Control Drug/Comparator Group) it includes 15 subjects qualifying inclusion criteria of the current study will be administered Virechana as Shodhana karma followed by Khadiradi Kashaya as Shamana Yoga along with Avalgujabijadi Lepa as an external application for 15 days starting from day-01 of trial, assessment of the patient during trial Before treatment, After Virechana Krama, After 15 days of Shamanayoga, Follow up after 45th day. The primary outcome measure will be Significant improvement noticed in reduction in signs and symptoms based on Vitiligo area severity index (VASI) and Vitiligo Disease Activity Score (VIDA) after 30 days. The secondary outcome measure will be Significant improvement noticed in the Quality of life (Vitiligo impact scale-22) of patient and reduction in signs and symptoms of Shwitra. after 30 days. Statistical analysis will be done through data obtained based on, before and after treatment assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects exhibiting the Sadhya Lakshanas of Shwitra i.e. Shwetha Mandala (white patch) Aparisravi (non-exudate) Ashukla Roma (no whitish discolouration of hairs) Anagnidagdha (patches which are not caused due to burn), will be selected Participants of irrespective gender, religion, occupation and socio-economic status within the age group of 18 to 60 years.
- •Chronicity of the disease should be less than 10 years.
- •Subjects assessed and fit for Virechana (therapeutic purgation).
排除标准
- •Patients with Systemic disorders like uncontrolled Diabetes mellitus, Hypertension, Hyper and Hypothyroidism that interfering with the course of treatment Patients unfit for Virechana karma Patients having chronicity more than 10 years Lesions over lip and genital areas Congenital pigmental disorders Other pigmented skin disorders Secondary depigmentation disorders caused due to burns & wounds.
研究者
Dr Shilpa D
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore