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临床试验/CTRI/2024/06/069564
CTRI/2024/06/069564尚未招募不适用

A Randomized Open Labelled Controlled Clinical Study to evaluate the Efficacy of Priyalbeejadi Lepa in the Management of Darunaka w.s.r Pityriasis Capitis

JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Patients of both sexes age group 16 to 40 years of Darunaka will be selected for relieving sign and symptoms

研究概览

简要总结

Ayurveda is the first and foremost spiritual science that offers a scientific approach to live in harmony with nature*. Ayurveda* is the most ancient healing science and ideal approach for an appropriate life style. According to this science, proper choice of Ahara  and Vihara helps to achieve healthy life by maintaining and / or restoring equilibrium of the body and mind.

In Ayurveda, Shira is said to be root of the plant for possessing all special senses and Prana, so one has to protect and care the Shira. Acharyas have explained different Shiroroga out of which Darunaka is one among them. Acharya Vagbhata have described 19 Shiroroga out of which 9 are Shirokapalaroga and “Darunaka” is one among them*. Acharya Sushruta* has included “Darunaka” under Kshudrarogas. It is a Roga affecting mainly the Kapala, that is scalp and it also hampers the normal healthy status of hair.Shirapradeshi Kandu (itching), Rukshata (dryness), Shirotwaka Sphutanam (cracking of the scalp skin with fine flakes), and Keshachyuti (hair-fall) are the cardinal symptoms of Darunaka which involves mainly vitiated Vata and Kapha Doshas.

Darunaka can be correlated with Pityriasis capitis also referred to as Pityriasis simplex capitis,  it is generally referred to as Dandruff. Pityriasis capitis is a disease characterized by itchy scalp and flakiness .Several microbial and non-microbial etiologies are considered for pathogenesis. Increased presence of Malassezia restricta has been reported as the key microbial etiological factor. Increased sebaceous gland activity, decreased skin hydration, skin irritation, immune suppression, or oxidative stress have also been proposed as non-microbial etiologies.

Due to frequent recurrences, Pityriasis Capitis represented as a very common dermatologic scalp condition in a wide range of population with estimating prevalence of 60.1% in South Asia, whereas 50% worldwide.Pityriasis Capitis is a scalp disorder affecting more than half of the global population. A survey in the United States showed that 50 million people suffer from dandruff annually and the prevalence is sharply increasing due to rapid urbanization.It occurs more frequently in adolescents, young adults.

Pityriasis Capitis is a scalp disorder with high rate of prevalence .There are many market preparations which are advised by modern dermatologists but it has some limitations as the effect is not long-lasting or cost of treatment is very high. As satisfactory results are not available, Patients are continuously looking with hope towards Ayurveda. Ayurveda plays an important role in the management of Darunaka as its unique treatment modality provides long-lasting results through three basic principles of treatment that is Nidana Parivarjana, Shodhana Chikitsa, and Shamana Aushadhis. Sthanika Chikitsa in terms of Lepa and Dhavana is also important in order to relieve the symptoms and nourish the hair.In present study one such formulation of Lepa which is given in Astang Samgraha Uttarsathana 28/33  is Priyalbeejadi Lepa(Trial drug) is taken to assess its efficacy on Darunaka wsr  to Pityriasis Capitis  and  compared with Aamrabeeja Haritaki Lepa (controlled)

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
16.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • 1.Subjects aged between 16-40 years.
  • 2.Patient representing signs and symptoms of Darunaka who will be willing to participate in the study.
  • 3.Subjects willing to participate with written informed consent, which is conveyed in the language which the subject can understand.

排除标准

  • 1.Eczema of scalp.
  • 2.Psoriasis of scalp.
  • 3.Immune- compromised conditions.
  • 4.Conditions in which head wash is restricted like Pratishyaya , injuries to scalp etc.
  • 5.Pregnant and lactating women.
  • 6.Subjects with uncontrolled systemic illness including diabetes mellitus, hypertension.

结局指标

主要结局

Patients of both sexes age group 16 to 40 years of Darunaka will be selected for relieving sign and symptoms

时间窗: Patients of both sexes age group 16 to 40 years of Darunaka will be selected for relieving sign and symptoms

次要结局

未报告次要终点

研究者

发起方
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DR DEEKSHANT THAKUR

JAMMU INSTITUTE OF AYURVEDA AND RESEARCH JAMMU

研究点 (1)

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