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临床试验/CTRI/2025/01/079511
CTRI/2025/01/079511尚未招募Phase 3 4

Randomized Comparative study to evaluate the efficacy of Khadirashtak kwatha and Brihat manjishtadi kwath in Ekakushta w s r Plaque psoriasis

Chaudhary Brahm Prakash Ayurved Charak Sansthan1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年2月5日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
Improvement in symptom severity of Ekakushtha

研究概览

简要总结

Ekakushta is one among eleven varieties of kshudrakusthas described in Ayurvedic classics. lt is characterized by Aswedanam (Anhydrotic/hypohydratic lesions), Mahavastu (covering of large surface area), Matsyashakalopamam(scaly lesions), Twacha which bears a greater resemblance with the symptoms of plaque psoriasis.

According to Charaka, the type of Kushtha which does not sweat, extensively spreads and resemble in the form of fish scale is known as Ekakustha. Ekakustha is Raktapradosaj vikara. The Doshadhikya of this disease is Vata-Kaphapradhan

It is described as one of the chronic disorders (Dirgha-Roga) by *Acharya Charaka.*According to Sushruta it is the type of Kshudrakushta in which the entire body become blackished.

Psoriasis is a common papulo-squamous disorder affecting 2% of the population and is characterized by well demarcated, red, scaly plaques. The skin becomes inflamed and hyper proliferates at about ten times the normal rate. It affects males and females equally and can involve all races. Psoriasis is T-lymphocyte-driven disorder that is a response to unidentified antigen. Un-identified triggers or infective agents like bacteria, HIV, drugs induce antigens which are presented to T lymphocytes by Langerhans cells of skin leading to a T cell activation activated cytokines that promote dermal inflammation and result into hyper-proliferation of epidermis.

Different patterns of psoriasis are recognized and can occur together, Certain drugs can make psoriasis worse; notably lithium, antimalarials and beta-blockers. Chronic plaque psoriasis is the most common type of psoriasis. It is characterized by pink-red, well demarcated plaques, with a silver scale seen especially on extensor surfaces of the knees and elbows.

Psoriasis is considered as a type of Kushta and may be correlated as Ekakushtha due to resemblance of signs and symptoms. In which both genetic and environmental influences have a critical role. The most characteristic lesions consist of red, scaly, sharply demarcated, and present particularly over extensor surfaces and scalp. There are many treatments available but because of its chronic recurrent nature psoriasis is a challenge to treat "Kustha is described as one of the most chronic disorders (Dirgha-Roga) by Acharya Charaka

GroupA-Khadirashtaka kwatha will be administered at the dosage of 40ml twice daily with lukewarm water one hour before meals.

Group B-Brihat Manjishtadi Kwathawill be administered at the dosage of 40ml twice daily with pippali and guggulu one hour before meals.

The study design is single-centred,open label,randomized,comparative,interventional study



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
21.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1 Patient showing sign and symptoms of Ekakushtha as mentioned in Charak Samhita 2 Patient within the age group of 21-60 years 3 Disease duration more than 1year and less than 5years 4 Patients not taking corticosteroids since last one month.

排除标准

  • 1 Patients of Diabetes mellitus, Thyroid disorder, tuberculosis, carcinoma, other life-threatening and complicated disease and major systemic illnesses 2 Severe condition of Psoriasis like Psoriatic arthritis 3 Disease duration less than 1year and more than 5years 4 Patients on treatment with any conventional oral medicines for last one month 5 Pregnant & lactating mother 6 Age below 21 and above 60 years.

结局指标

主要结局

Improvement in symptom severity of Ekakushtha

时间窗: 30days

次要结局

  • Improvement in Psoriasis Area and Severity Index (PASI)Score

研究者

发起方
Chaudhary Brahm Prakash Ayurved Charak Sansthan
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Megha K

Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar

研究点 (1)

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