Pharmaceutical Development, Standardization and Clinical Evaluation of the efficacy of Arjuna, Manjishtha and Vasa (AMV) Lepa and Cream in Vyang (Melasma)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- 4. Improvement in Melasma Area and Severity Index Score (MASI Score)
研究概览
简要总结
Among the numerous conditions that impact cosmetic appearance, Vyanga stands out as a prevalent skin ailment recognized from thousands of years. Though it is considered as Kshudra Rog (minor disease), it holds major importance as a cosmetic problem within the society.As per Ayurveda classics, Vyanga has been described by Acharya Sushruta with
characteristics features of Niruja (painless), Tanu (thin) and Shayava varna Mandalas (bluish-black patches) on face. Acharya Charak has also described Vyanga as a “Bahirmargaj vyadhiâ€, the disease that occurs in the extremities. Acharya Vagbhat has mentioned Vyanga in Kshudra roga characterized by Shyama (Dark coloured/Black), Tanu (thin), Mandal (circular) patches on face.Only Ashtanga Sangraha and Ashtanga Hrudaya have mentioned types of Vyanga along with the symptoms on the basis of Doshik predominance.
On comparative analysis of Vyanga with the modern medical science Melasma show congruence with Vyanga Melasma is a skin condition characterized by the development of brown to gray-brown patches or spots on the skin, commonly on the face. The reported prevalence of melasma ranges from 0.25 - 4.0% in several southeast Asian population.
In Ayurvedic literature, Lepa (external application), Siravyadha (bloodletting) Abhyanga (oil massage) and Nasya (nasal drop instillation) are described as therapeutic options for the management of Vyanga. Among them Lepa is considered to be one of the simple & effective procedure. This study aims to evaluate the effiacy of Arjuna Manjishtha and Vasa (AMV) Lepa in Vyanga ( melasma)as mentioned in Yogratnakar Kshudrarog adhikar .Since the preparation and application of Lepa is inconvenient, time consuming and fairly cluttered for patients in comparison to cream. Keeping this in view, Cream is also developed for local application in present study and Evaluated for its clinical effficacy in Vyanga (melasma).
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
- 25.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients belonging to the age group of 25 to 55 years
- •Patients with the classical signs and symptoms of disease Vyanga (Melasma) i.e Shyava (Varna), Tanu (alpa), Niruja mandalas 3.Patients having the chronicity of disease for less than 5 years 4.Patients not using any topical treatment for melasma for 2 weeks prior to enrollment in the study 5.Patients willing to participate in study trial and give written informed consent.
排除标准
- •Pregnant women and lactating mothers.
- •Vyanga (Melasma) caused since birth like Nevus of Ota etc.
- •Patients having Vyanga (Melasma) as a symptom of major systemic diseases like S.L.E, Addison’s disease etc., or as a result of adverse effect of any drug or caused by tumor like malignant melanoma.
- •Patients taking oral contraceptive pills & injected depot contraceptive preparations.
结局指标
主要结局
4. Improvement in Melasma Area and Severity Index Score (MASI Score)
时间窗: 2 months
4. Improvement in Physician global assessment scale (PAGI)
时间窗: 2 months
1. Prepared and standardized AMV Cream.
时间窗: 2 months
2. Improvement in Clinical signs and symptoms of Vyanga (Melasma)
时间窗: 2 months
次要结局
- Improvement in the Melasma Quality of Life index (MELAS Qol)(2 months)
研究者
Sabahat Anjum
Ayurvedic and Unani Tibbia college and Hospital