Clinical study to evaluate efficacy of Vishwamitra Kapala Malahara locally in Vicharchika.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- To study the Vishwamitra Kapala Malahara twice daily locally for the period of 30 days in age
研究概览
简要总结
The present study is planned to evaluate the efficacy of Vishwamitra Kapala Malahara in the management of Vicharchika, a chronic relapsing skin disorder described in Ayurveda as a type of Kshudra Kushta and correlated with eczema in modern medicine. Vicharchika is characterized by itching, eruptions, discoloration and discharge, causing considerable physical, cosmetic and psychological burden. Modern treatment with corticosteroids and emollients offers only temporary relief with chances of recurrence, while Ayurveda provides holistic alternatives. According to Ayurvedic principles, Vicharchika is Tridoshaja with Kapha predominance and involvement of Rasa, Rakta, Mamsa and Kleda. Vishwamitra Kapala Malahara, a traditional formulation from Vaidya parampara, though not mentioned in classical texts, has been reported to show beneficial effects in skin diseases but has not been scientifically evaluated in Maharashtra.
This study will be a single arm controlled clinical trial conducted at the OPD and IPD of Kayachikitsa departments at Solapur and Pune. A total of 108 patients of either gender, aged 18 to 60 years, fulfilling the diagnostic criteria of Vicharchika will be enrolled. The intervention will consist of local application of Vishwamitra Kapala Malahara twice daily for 30 days, with follow-up on day 0, 15 and 30. Assessment will be done using subjective criteria such as Kandu, Pidaka, Vaivarnya and Srava, along with objective scoring through the Eczema Area and Severity Index (EASI). Data will be analyzed using appropriate statistical methods to evaluate significance of outcomes.
The formulation will be prepared from coconut shells using Bhallataka Patan Yantra for oil extraction and mixed with Tuttha to form Malahara. The expected outcome is reduction in clinical symptoms, improved quality of life, minimal adverse effects and establishment of a safe, cost-effective Ayurvedic intervention for Vicharchika, thereby providing scientific validation to this traditional Anubhuta Yog.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
入选标准
- •Age group:- 18 to 60 years.
- •2.Patients with Clinical features of Vicharchika having signs and symptoms namely Kandu (itching),Pidaka(Eruption),Vaivarnya(Depigmentation) and Srava (Discharge).
- •3.Patients of both Gender.
- •4.Understanding and being willing to sign the informed consent form.
排除标准
- •Patient having severe systemic diseases or condition along with Vicharchika.
- •Pregnant & Lactating woman.
结局指标
主要结局
To study the Vishwamitra Kapala Malahara twice daily locally for the period of 30 days in age
时间窗: 30 Days. | Patient will be screened on 15th and 30th days.
group of 18 to 60 years with irrespective of gender in Vicharchika using EASI SCALE.
时间窗: 30 Days. | Patient will be screened on 15th and 30th days.
次要结局
- 1.To Study any adverse reaction of drug to the patient.(2.To study the disease Vicharchika in detail with Ayurveda)
研究者
Dr Japa Jayant Phadke
Seth Govindaji Raoji Ayurved Mahavidyalaya,Solapur