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临床试验/CTRI/2024/10/075031
CTRI/2024/10/075031尚未招募不适用

A Comparative Clinical Study To Evaluate The Efficacy Of Indrayava Lepa And Dhattura Patra Lepa After Pracchana Karma In The Management Of Indralupta With Special Reference To Alopecia Areata

Dr Sushma R B1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月19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
1) New Hair follicle growth on affected site

研究概览

简要总结

Indralupta is one among the shiro kapalagata roga explained by Acharya Vagbhata and kshudra roga by Acharya Sushruta. It is characterized by patchy hair loss from scalp. It occurs when vitiated pitta associated with Vata gets localized in the roma kupa and causes the hairfall, later on kapha dosha in association with rakta, causes the obstruction to the hair roots and restricts their re growth. The symptoms of indralupta like patchy hair loss, restricted regrowth mimics Alopecia areata in modern science.

Alopecia areata is a dermatologic condition characterized in its limited form by circumscribed round or oval patches with well-demarcated borders between normal and affected scalp. As per the recent statistical data, Alopecia areata affects 0.1 to 0.2% of human population. It occurs in both male and female. It is most common in early adults. It is seen that an incidence of Alopecia areata tends to be higher when associated with diseases affecting the immune system.

In modern system of medicine, the treatment for Alopecia areata has been showing less encouraging results, as they are treating the condition with corticosteroids both internally and externally. Other treatment include Minoxidile, UVR, laser therapy, hormonal therapy and hair transplantation,etc, this type of conventional management is minimum effective, associated with some side effects and also the cost of these treatments are high. As hair is one’s crown and glory, hair disorders cause negative impact towards the individual’s quality of life. Hence, world is expecting treatment for this disease from other medical sciences.

So,in Ayurveda, both shodana and shamana treatment are indicated in Indralupta. Here, pracchana acts as shodana therapy, lepa acts as shamana therapy. Prachanna clears the obstructed romakupas, drains out the vitiated blood from the srotas and later when lepa is applied over the region it get absorbed by hair follicle which open up the pores thus facilitates easy and faster absorption of the drug and helps in the re-growth of healthy hair.

Basavarajeeyam, a famous treatise in Ayurveda, mentioned Indrayava lepa in the management of Indralupta, Acharya Vagbhata mentioned Dhattura patra lepa so, this study is planned to know the effectiveness of pracchana karma followed by Indrayava lepa and Dhattura patra application. Both Indrayava and Dhattura are readily available and cost effective ,hence chosen for the study.

HYPOTHESIS:

Null hypothesis:

H0: Indrayava lepa after Pracchana karma has no significant effect in Indralupta

Alternate hypothesis:

H1: Indrayava lepa after Pracchana karma has more effect than Dhattura patra lepa after Pracchana karma in Indralupta

H2: Indrayava lepa after Pracchana karma has less effect than Dhattura patra lepa after Pracchana karma in Indralupta

H3: Indrayava lepa after Pracchana karma and Dhattura patra lepa after Pracchana karma are equally effective in Indralupta

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
15.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Subjects having the clinical features of patchy hairloss occuring anywhere in the scalp.
  • Age group between 15-40 will be included.
  • Irrespective of gender.
  • Irrespective of size and number of patches on the scalp.

排除标准

  • Subjects with other form of Alopecia areata like Alopecia totalis and Alopecia universalis.
  • Alopecia due to other scalp disorders like Tinea capitis, Trichotillomania, Tilogen Effluvium and Traumatic alopecia.
  • Subjects with endocrine disorders eg: Hypothyroidism, Uncontrolled Diabetes.

结局指标

主要结局

1) New Hair follicle growth on affected site

时间窗: 58 days

2) Reduction in the size of the bald spot

时间窗: 58 days

3) Reduction in the symptoms such as itching etc

时间窗: 58 days

次要结局

  • 1) SALT Score(2) Pictorial presentation before and after treatment)

研究者

发起方
Dr Sushma R B
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sushma R B

Government Ayurveda Medical College, Bengaluru

研究点 (1)

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