A RANDOMIZED DOUBLE ARM COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF AVALGUJADI LEPA AND VAYASYADI LEPA ALONG WITH LODRASAVA IN THE MANAGEMENT OF SHWITRA VIS-A-VIS VITILIGO
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Colour of patch
研究概览
简要总结
SAMPLE SIZE: Minimum of 40 subjects will be selected randomly and categorized into two Groups: Group A and Group B.
GROUP A:
SAMPLE SIZE : Minimum of 20 Subjects
AMA-PACHANA : Trikatu churna, 3gm with ushnajala as Anupana, Before food, Twice a day, till Nirama Avastha attained.
SHAMANOUSHADHI : Lodrasava, 15ml with ushnajala as Anupana, After food,Twice a day for 30 days
LEPA PRAYOGA : Avalgujadi Lepa with gomutra for application Once in a day (morning), for 30 days
GROUP B:
SAMPLE SIZE : Minimum of 20 Subjects
AMA- PACHANA : Trikatu churna 3gm with ushnajala as Anupana, Before food, Twice a day, till Nirama Avastha attained.
SHAMANOUSHADHI : Lodrasava,15ml with ushnajala as Anupana, After food,Twice a day for 30 days
LEPA PRAYOGA : Vayasyadi Lepa with ajamutra for application Once in a day (morning), for 30 days
Total Duration: 30 days
Follow up: 1. Follow up during intervention period: On 15th day, 30th day
- Follow up on completion of the intervention: 45th day, 60th day post treatment
PATHYAPATHYA: Subjects of both Groups will be advised Pathya Apathya.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects presenting with the clinical features of Shwitra(Vitiligo).
- •Subjects of either gender between age group of 15-60 years.
- •Subjects with single or less than 5 localised white patches having surface area less than 6 sq.cm.will be selected.
- •Subjects with history of not more than one year of onset.
排除标准
- •Subjects having patch over the sites like lips, glans penis, ear lobes and nail bed.
- •Subjects associated with Leucoderma, albinism and other skin diseases.
- •Subjects suffering from systemic disorders like uncontrolled Diabetes Mellitus, HIV, HBsAg positive.
- •Pregnant and lactating women.
结局指标
主要结局
1. Colour of patch
时间窗: 30 days
2. Size of patch
时间窗: 30 days
3. Number of patch
时间窗: 30 days
SUBJECTIVE PARAMETERS
时间窗: 30 days
1. Daha (Burning sensation)
时间窗: 30 days
OBJECTIVE PARAMETERS
时间窗: 30 days
Objective parameters are taken based on the Vitiligo Extent Tensity Index score
时间窗: 30 days
次要结局
- SUBJECTIVE PARAMETERS(1. Daha (Burning sensation))
研究者
Dr Tejaswini Lohar
Ayurveda Mahavidyalaya and Hospital, Hubballi