Randomized Open Label Controlled Clinical Study to Evaluate the Efficacy of Arkaksheeradi Lepa in the Management of Vyanga with special reference to Melasma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.Significant decrease in melasma pigmentation based on modified MASI Score.
研究概览
简要总结
- Healthy skin is a reflection of an individual’s overall health. Any skin conditions especially on face not only reduces self confidence but also causes stress, anxiety and depression which in turn impairs the individuals quality of life.
Vyanga is one among Kshudra rogas, characterised by Niruja and Shyava varna Mandalas on Mukhapradesha. On the basis of clinical features of *Vyanga,*it can be compared to Melasma Melasma is an acquired hyperpigmentation that is characterized by bilateral irregular brown macules and patches on sun exposed areas of the face.
Melasma affects 40% of the Indian population, according to previous studies. Darker skin types and females are more likely to experience it.In Ayurveda classics many treatment modalities were explained for Vyanga and Lepa is one among them, which helps to enhance complexion.
Among those Lepas, Arkaksheeradi lepa is mentioned for Mukhakarshnya and could be effective in the management of Vyanga.
Arkaksheeradi lepa contains Arka Ksheera, Haridra and Daruharidra. These Dravyas have Kushtangna, Kandughna, Raktashodhaka, Twak prasadakara and Varnyakara properties & can aid in depigmentation by removing twak vaivarnya. Hence the study aims to evaluate the effect of Arkaksheeradi lepain Vyanga.
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
- 21.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with Melasma of either gender within the age group between 21 – 50 years will be selected.
- •Subjects with Melasma chronicity less than 5 years.
- •Subjects fulfilling the diagnostic criteria of Melasma with special reference to Vyanga will be randomly selected.
- •Subjects who are willing to participate in the study.
排除标准
- •Individuals with Hyper-pigmentary disorders other than Melasma.
- •Females on oral contraceptive pills, pregnant women, lactating women.
- •Hyperpigmentation since birth.
结局指标
主要结局
1.Significant decrease in melasma pigmentation based on modified MASI Score.
时间窗: 1st Assessment – 0 day | 2nd Assessment – 15th day | 3rd Assessment – 30th day | Follow up (without medication) – 45th day
2.Significant decrease in the colour and number of lesions based on the arbitrary grading and fairness meter scale.
时间窗: 1st Assessment – 0 day | 2nd Assessment – 15th day | 3rd Assessment – 30th day | Follow up (without medication) – 45th day
次要结局
- 1.Generation of in depth analysed data on different aspect of disease and its treatment.(2.Generation of data on possible unexpected drug reaction.)
研究者
Dr Devisree Babu T S
Sri Sri College of Ayurvedic Science and Research