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临床试验/CTRI/2022/03/041344
CTRI/2022/03/041344尚未招募1 期

A comparative clinical study to evaluate the efficacy of shiroabhyanga with kantakariphala taila and japapushpa taila in darunaka wsr to pityriasis capitis

Sri vijayamahantesh Ayurveda Medical college and Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年3月30日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To Evaluate the changes in dryness, Itching sensation.

研究概览

简要总结

Name of the department: Departmernt of Panchakarma

Name of the Guide: Dr G S Badarinath

Title of the Study: "A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF SHIROABHYANGA WITH KANTAKARIPHALA TAILA AND JAPA PUSHPA TAILA IN DARUNAKA W.S.R TO PITYRIASIS CAPITIS"

Ayurveda is the traditional ancient Indian system of health science. The ayurvedic method of holistic health care emphasizes balancing the body, mind and spirit to treat and prevent diseases. Increasing urbanization and industrialization have posed greater danger due to air pollution, contamination of water, liberation of toxic, allergic and poisonous things that causes disorders of ShiraAcharyas Sushruta and other Acharyas like Yogaratnakara, Bhavaprakasha, Vangasena, explained this disease under Kshudrarogas(minor diseases). There are nineteen diseases described by Acharyas Vagbhata in Shiroroga pratishedha adhyaya, they are 9 Kapalagata rogas and 10 Shiroroga. Acc to Vagbhata Acharya Darunaka is a Kapalagata roga.

Darunaka occurs due to vitiation of kapha and vata dosha, which results in manifestation of features like kandu , rukshata of keshabhumi , twaksputana,  keshachyuti. Even though Darunaka is not life threatening disease, it has high cosmetic importance.

On the basis of symptoms of Darunaka, it can be compared with Pityriasis capitis (Dandruff),  It mainly affects the scalp and characterized by itching, flaking of skin and hair loss6. It is related to hygiene and it will be more visible if person does not wash or brush hair more often. It is found to affect more than 50% of the population that too more in males than females. Day by day its prevalence rate is increasing as it frequently relapses.In reference to Pityriasis capitis treatment, Modern science has symptomatic management with Coal tar which causes side effects like Skin irritation, Sun sensitivity, Allergic reactions. Antifungal shampoos which are effective at the time of use and it reoccurs when they are stopped and they are too expensive also, so there is need to find  safe, effective, and economical remedy for the treatment of Darunaka.

The clinical trials which are going to be conducted in Ilkal, which is famous for granite factories , where the labourers are more often exposed to dust and sunlight , so here there is more prominence of Darunaka. From the ancient time ayurveda has adopted an easy procedure called Shiroabhyanga which is proven effective therapy not only in Darunaka but also in other Shirorogas. This procedure is simple, easy and can be employed by everybody without any complications.

Ayurveda classics suggested different procedures like murdni taila1 (i.e Shiroabhyanga, Shiroseka, Shiropichu,Shirobasti ) to treat the Shirorogas effectively. Shiroabhyanga , Shiroseka, Shirobasti, Nasya and Raktamokshana are said for the treatment of Darunaka. Among these Shiroabhyanga with Kantakariphala taila and Japa pushpa taila is selected for a comparative study to prove their efficacy.

AIMS AND OBJECTIVES OF THE STUDY:

To clinically evaluate the efficacy of Shiroabhyanga with Kantakariphala taila in Darunaka

To clinically evaluate the efficacy of Shiroabhyanga with Japa pushpa taila in Darunaka

To compare the efficacy of Shiroabhyanga with Kantakariphala taila and Japa pushpa taila in Darunaka.

HYPOTHESIS

H0 : Neither Kantakariphala taila shiroabhyanga nor japapushpa taila shiroabhyanga are  effective in Darunaka

H1: Kantakariphala taila shiroabhyanga is effective than Japa pushpa taila shiroabhyanga in Darunaka.

H2: Japa pushpa taila shiroabhyanga is effective than Kantakariphala taila shiroabhyanga in Darunaka.

MATERIALS AND METHODS:

SOURCE OF DATA: Patient suffering from Darunaka will be randomly selected from OPD & IPD dept of Panchakarma after proper diagnosis at RPK Ayurvedic hospital Ilkal, Bagalkot dist.

Literary: literary aspect of the Darunaka will be collected from classical Ayurvedic and modern text with updated recent medical journals and websites.

Selection of drug :a) kantakariphala taila

b) japapushpa taila

METHOD OF COLLECTION OF DATA

a) Study design: It is randomized comparative clinical study.

b) Sample size: A minimum of 40 patients of Darunaka irrespective of Gender and occupation       aged between 18 to 60 yrs will be selected and assigned randomly into 2 groups with minimum   20 patients in each group.

c) Criteria for diagnosis: Diagnosis will be made on the basis of the classical signs and symptoms as mentioned in texts.

Patients who present with shirokandu , keshachyuti , keshabhoomi rookshata , twaksphutana

d) Inclusion criteria:

Age group between 18 to 60yrs.

The patients who have signs and symptoms of darunaka  will be included.

Patients fit for Shiroabhyanga

e)Exclusion criteria:

The patients suffering from other types of scalp diseases like Psoriasis, Infective condition will be excluded.

f) Intervention :

Group A                               : Minimum 20 patients

Drug                                       : kantakariphala taila

Time                                       : morning

Dose                                       : sufficient quantity

Duration                                 : 7 days

Route of administration         : External application

Follow up period                    : 8th day, 15th day, 22st day

 Group B                                  : minimum 20 patients

Drug                                        : japapushpa taila

Time                                        : morning

Dose                                        : sufficient quantity

Duration                                  : 7 days

Route of administration          : External application

Follow up period                    : 8th day, 15th day, 22st Day

g) STUDY DURATION: 22 days

h) ASSESMENT OF RESULT:

Criteria for the assessment of result:

Assessment will be done by subjective and objective parameters before and after treatment. Result will be analysed statistically by using suitable test with the help of statistician.

SUBJECTIVE PARAMETERS

Shirokandu (itching of scalp )

Keshachuti ( hairfall )

Shirorukshata  (dryness of scalp )

Twaksphutana   (scaling of scalp)

Daruna (hard scalp)

Svapa(loss of touch sensation )

j)OBJECTIVE PARAMETERS

Adherent scalp flaking score (ASFS)

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
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

  • Age group between 18 to 60 years.
  • The patients who have signs and symptoms.
  • Patients fit for Shiroabhyanga.

排除标准

  • The patients suffering from other type of scalp diseases like Psoriasis, infective conditions will be excluded.

结局指标

主要结局

To Evaluate the changes in dryness, Itching sensation.

时间窗: 8th, 15th and 22nd day.

次要结局

  • To Evaluate the changes in hairfall and scaling of scalp.(8th, 15th and 22nd day)

研究者

发起方
Sri vijayamahantesh Ayurveda Medical college and Hospital
申办方类型
Private medical college

研究点 (1)

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