A non-randomized, observational clinical study on formulation containing aqueous juice of Telosma pallida (Roxb.) Craib. Fruit for the treatment of white patches on the skin (leucoderma)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Skin color will be changed towards normal from hyperpigmentation.
研究概览
简要总结
This will be non-randomized, open label, clinical observational study. The study will be planned to generate the scientific data on the use of traditional medicine on leucoderma.
Treatment protocol
Lotion or any other suitable formulation containing aqueous juice of fruits of Telosma pallida will be provided to the patients.
Patients will be instructed to apply the sufficient amount of lotion on the white patches in the morning and expose the affected part in the sunlight for at least 20 to 30 minutes. At night, the lotion will be applied and left it overnight. In the morning, after taking bath, again morning application will be made.
Details of study procedures:
All the patients, who fulfill the inclusion criteria, will select for the study from the in-patient and out-patient department of the P. D. Patel Ayurved Hospital, Nadiad. The patients will be instructed to take conventional treatment for leucoderma and do not apply any allopathy medicine during the treatment period.
Patient having mild to moderate leucoderma will be kept as a treatment group. There is no control group in the present study. All the patients under the treatment group will be provided herbal formulation containing juice of fruits of Telosma pallida (lotion or any other suitable formulation) to apply on the affected area twice a day.
Formulation to be given to the patient will be prepared at the Faculty of Pharmacy, Dharmsinh Desai University, Nadiad.
All the patients will be clinically assessed before and after treatment. Signs and symptoms will be assessed by giving score. The grade score of signs and symptoms are prepared from us.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patient with confirmed leucoderma due to genetic or non-genetic reason can be included in the study.
排除标准
- •Female patients having pregnancy, breast feeding or post-delivery period.
- •Patients having evidence of extensive disease or any other treatment is continue.
- •Patients having patches or white spots due to chemical or burning hazard.
结局指标
主要结局
Skin color will be changed towards normal from hyperpigmentation.
时间窗: Time-point is 4 weeks.
This will be evaluated using the method given by Geel et al. (2020).
时间窗: Time-point is 4 weeks.
1. confetti-like depigmentation
时间窗: Time-point is 4 weeks.
2. Koebner phenomenon
时间窗: Time-point is 4 weeks.
3. hypochromic areas/borders
时间窗: Time-point is 4 weeks.
次要结局
- Size of the white patches or number of white patches will be reduced. The size of the white patches may be measured by putting a transparent plastic sheet on the skin & draw the area of the patch using pointed marker pen.(The scoring method to assess the effect of the treatment will be adopted.)
研究者
Punitkumar R Bhatt
Faculty of Pharmacy, Dharmsinh Desai University