An etiopathological assessment and upashayatmaka effect of asanadi gana in middle adulthood shvitra (non segmental vitiligo population)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To understand the key Nidanas (etiopathological factors) of Shvitra (Non- segmental vitiligo)
研究概览
简要总结
Brief of the study: Shvitra (Non-segmental vitiligo), though non-lethal, has profound psychological, social, and emotional impacts, often leading to anxiety, low self-esteem, social withdrawal, and even suicidal tendencies due to visible skin lesions and resulting stigma. Ayurveda recognizes Shvitra as a *Nidanaarthak Vyadhi,*a disease stemming from deep-rooted causes highlighting its multifactorial nature involving genetic, autoimmune, psychological, dietary, and lifestyle factors. Supported by Acharya Charaka’s principle of complex causation, Shvitra’s rising incidence in middle adulthood is linked to modern lifestyle disorders like diabetes, obesity, and hypertension. This study aims to explore these underlying causes in middle-aged individuals to enable holistic, root-cause-oriented management rather than merely addressing symptoms.
Assessment criteria: 1. To evaluate the severity of the disease, grading of the clinical signs and symptoms of Shvitra (Non-segmental vitiligo) will be assessed before and after the intervention 2. Vitiligo Extent Tensity Index (VETI) score 20 for vitiligo will be assess before and after intervention. 3. S100B and CD8+ will be evaluated before and after intervention.
DIAGNOSTIC CRITERIA : Subjective Criteria: Clinical signs and symptoms of Shvitra (Non-segmental vitiligo) mentioned in classical texts: Ruksha, Aruna, Tamra, Kamalapatravat,Sadaha, Romavidvanshi, Shweta,Ghana, Guru, Sakandu, Number of lesions, Body surface Area (BSA) involved 2. Objective Criteria: Woods lamp Examination
END POINT : Resolution in signs and symptoms of Shvitra (Non-segmental vitiligo) in middle adulthood population.
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
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with Shvitra (Non segmental vitiligo) up to the maximum chronicity of 5 years based on clinical signs and symptoms.
- •Patients who are middle adulthood population (40 to 65 years of age), irrespective of gender, religion, occupation, and socioeconomic status.
- •Individuals who are willing to participate in the study.
- •Individuals willing to give written informed consent.
排除标准
- •Patients having conditions like Post inflammatory Hypopigmentation, Morphea, Leprosy (Pinprick test will be done for DD), Lichen sclerosis, Pityriasis alba, Leukoderma due to melanoma, Tinea versicolor, Albinism, Burn, and Wounds.
- •Patients having uncontrolled Diabetes mellitus, Hypertension, Hypothyroidism and Hyperlipidaemia.
- •Pregnant and lactating women.
- •Patient having any other severe systemic disorders.
- •Carcinoma, Hepatic failure, CKD, SLE.
- •Patient taking oral corticosteroids.
- •Non-co-operative patients.
- •7.Patient who was enrolled in different study in the last 3 months.
结局指标
主要结局
To understand the key Nidanas (etiopathological factors) of Shvitra (Non- segmental vitiligo)
时间窗: The duration of total study will be 45 days including 4 visits i.e., Day 0, Day 15, Day 30, Day 45
among middle-adulthood population using a validated questionnaire- Integrated
时间窗: The duration of total study will be 45 days including 4 visits i.e., Day 0, Day 15, Day 30, Day 45
Etiopathological Assessment Questionnaire for Shvitra (IEAQS).
时间窗: The duration of total study will be 45 days including 4 visits i.e., Day 0, Day 15, Day 30, Day 45
次要结局
- Clinical effectiveness of Asanadi Gana Kashaya in reducing the extent, severity, and symptomatology of vitiligo lesions, as assessed by standardized outcome measures (e.g.(VETI, VIS-22).)
- Evaluation of the Upashayatmaka effect of Asanadi Gana Kashaya on the progression and stability of Shvitra (Non-segmental vitiligo).(The duration of total study will be 45 days including 4 visits i.e., Day 0, Day 15, Day 30, Day 45)
- Improvement in clinical features including lesion re-pigmentation, number and size of(patches, and associated subjective symptoms (e.g., itching, dryness).)
- Biochemical assessment of treatment response through pre- and post-intervention levels of(S100B and CD8+ markers as surrogate indicators of autoimmune activity and disease activity.)
研究者
Dr Geetanjali Meena
All India Institute Of Ayurveda