A Randomised Comparative Clinical Study to Evaluate the Efficacy of Kushthadalan Ras, Darvyadi Kwath and Somraji Taila in the Management of Sidhma Kushtha with special reference to Psoriasis Vulgaris.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in the PASI SCORE
研究概览
简要总结
Disease reference:- Sidhma Kushtha mentioned in Charak Samhita Nidana(5/6)and Chikitsa sthan (7/19)
शà¥à¤µà¥‡à¤¤à¤‚ तामà¥à¤°à¤‚ तनॠच यदà¥à¤°à¤œà¥‹ घृषà¥à¤Ÿà¤‚ विमà¥à¤žà¥à¤šà¤¤à¤¿| अलाबूपà¥à¤·à¥à¤ªà¤µà¤°à¥à¤£à¤‚ ततॠसिधà¥à¤®à¤‚ पà¥à¤°à¤¾à¤¯à¥‡à¤£ चोरसि|| (Ch. Chi. 7/19)
In Sushrut Samhita Nidana Sthana (5/12)
In Ashtang Hridaya Nidana Sthana (14/22)
Drug reference :- 1*. Kushthadalan Ras: Raskamdhenu* 41/330
2.Somraji Taila: Chakradatta Kushthachikitsa 163,164,165
3.Darvyadi Kwath: Astang Hridaya Chikitsa Sthan-Kushthachikitsa 19/37
Need of Study: -
1. The worldwide burden of Psoriasis is 2%, and the prevalence of Psoriasis in India ranges from 0.44% to 2.8%.
2. Now a days Psoriasis became a most common type of skin disease. The modern stressful lifestyles, lack of adequate physical activities, and associated risk of metabolic syndrome. A lots of research work has already been done in but still a promising cure for Psoriasis is not found.
3. Modern medicine treats Psoriasis with PUVA, Topical and Systemic corticosteroids and anti mitotic drugs which give serious side effects like bone marrow depletion, liver toxicity, and also having recurrence of disease.
4. Ayurveda has a great potential in the management of Psoriasis and its associated complications.
5. Since every person is not suitable for Shodhana chikitsa , so in present study focusing on Shaman chikitsa for Sidhma Kushtha.
6. Since Kushtha is a Tridoshaja Vyadhi, it also a rakta pradoshaja vikara, and Sidhma Kushtha is a Vata Kapha dominant disorder.So Kushthadalan Ras, Darvyadi Kwath and Somraji Tailamay be effective in the Shaman of vata , kapha as well as rakta dosha of Sidhma Kushtha (Psoriasis Vulgaris ).
Hypothesis:
Null Hypothesis Ho:
There is no difference between the efficacy of Kushthadalan Ras & Somraji Taila and Darvyadi Kwath & Somraji Taila in the management of Sidhma Kushtha W.S.R. to Psoriasis Vulgaris.
**Follow up:**After 15 days, 30th day, 45th day, and after completion of trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having chronicity of Psoriasis less then 5 years duration.
- •Patient having any clinical signs and symptoms of Sidhma Kushtha as per Ayurvedic classics and Psoriasis as per modern classics.
- •Sveta tamra varna (white coppary in colour) 2.
- •Tanu ( thin) 2.
- •Alabupushpavarnam [resembles the flower of alabu (Lagenaria siceraria) discoloration] 2.
- •Ghrustam vimunchati (scaling) 2.
- •Rukshta (dryness) 2.
- •Kandu (itching) 2.
- •Patient willing to give consent for clinical trial.
排除标准
- •Patients on long term steroid and cytotoxic drugs.
- •Patients having illness like uncontrolled HTN,DM-II and Cardiac and Renal disorders, malignant diseases, major liver disorders, immunocompromised hosts etc.
- •Pregnant and lactating women.
- •Patients having complications of psoriasis like psoriasis arthropathy.
结局指标
主要结局
Changes in the PASI SCORE
时间窗: 60 DAYS
次要结局
- •Changes in Subjective parameters(1.Kandu (Itching index))