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

Phase 1
Not yet recruiting
Conditions
Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: DARUNAKAH, (2) ICD-10 Condition: L210||Seborrhea capitis. Ayurveda Condition: DARUNAKAH,
Registration Number
CTRI/2022/03/041344
Lead Sponsor
Sri vijayamahantesh Ayurveda Medical college and Hospital
Brief Summary

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 *Shira*. *Acharyas 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*,S*hirobasti* ) to treat the Shirorogas effectively. Shiroabhyanga , Shiroseka, Shirobasti, Nasya and Raktamokshana are said for the treatment of Darunaka. Among these *Shiroabhyanga* with K*antakariphala* *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)

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
40
Inclusion Criteria
  • 1)Age group between 18 to 60 years.
  • 2)The patients who have signs and symptoms.
  • 3)Patients fit for Shiroabhyanga.
Exclusion Criteria

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To Evaluate the changes in dryness, Itching sensation.8th, 15th and 22nd day.
Secondary Outcome Measures
NameTimeMethod
To Evaluate the changes in hairfall and scaling of scalp.8th, 15th and 22nd day

Trial Locations

Locations (1)

R P Karadi Hospital Ilkal

🇮🇳

Bagalkot, KARNATAKA, India

R P Karadi Hospital Ilkal
🇮🇳Bagalkot, KARNATAKA, India
Shrinidhi Havaragi
Principal investigator
8073617858
shrinidhisinchana@gmail.com

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