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CTRI Number  CTRI/2022/03/041344 [Registered on: 24/03/2022] Trial Registered Prospectively
Last Modified On: 23/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to evaluate the effect of shiroabhyanga with kantakariphala taila and japapushpa taila in darunaka wsr to pityriasis capitis  
Scientific Title of Study   A comparative clinical study to evaluate the efficacy of shiroabhyanga with kantakariphala taila and japapushpa taila in darunaka wsr to pityriasis capitis  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shrinidhi Havaragi 
Designation  PG Student 
Affiliation  Sri vijayamahantesh ayurveda college and Hospitals 
Address  dept of Panchakarma, Sri vijayamahantesh Ayurvedic Medical college and R P Karadi hospital ilkal-587125.dist Bagalkot State Karnataka INDIA

Bagalkot
KARNATAKA
587125
India 
Phone  8073617858  
Fax    
Email  shrinidhisinchana@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr G S Badarinath 
Designation  Professer and HOD 
Affiliation  Sri vijayamahantesh ayurveda college and Hospitals 
Address  dept of Panchakarma, Sri vijayamahantesh Ayurvedic Medical college and R P Karadi hospital ilkal-587125.dist Bagalkot State Karnataka INDIA

Bagalkot
KARNATAKA
587125
India 
Phone  7795768903  
Fax    
Email  sastrybg.2010@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shrinidhi Havaragi 
Designation  PG scholar 
Affiliation  Sri vijayamahantesh ayurveda college and Hospitals 
Address  dept of Panchakarma, Sri vijayamahantesh Ayurvedic Medical college and R P Karadi hospital ilkal-587125.dist Bagalkot State Karnataka INDIA

Bagalkot
KARNATAKA
587125
India 
Phone  8073617858  
Fax    
Email  shrinidhisinchana@gmail.com  
 
Source of Monetary or Material Support  
Sri vijayamahantesh Ayurveda Medical and Hospital Ilkal 
 
Primary Sponsor  
Name  Sri vijayamahantesh Ayurveda Medical college and Hospital 
Address  Sri vijayamahantesh Ayurveda Medical college and Hospital Ilkal 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shrinidhi Havaragi  R P Karadi Hospital Ilkal  OPD of Panchakarma, Sri vijayamahantesh Ayurveda Medical college and R P karadi Hospital Ilkal-587125 Dist Bagalkot KARNATAKA
Bagalkot
KARNATAKA 
8073617858

shrinidhisinchana@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Vijaya Mahantesh Ayurvedic medical college and R P Karadi Ayurveda Hospital ILkal Bagalkot  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: DARUNAKAH, (2) ICD-10 Condition:L210||Seborrhea capitis. Ayurveda Condition: DARUNAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Siro~aBya~ggaH, शिरोरऽभ्यंग (Procedure Reference: Astanga Hridaya, Procedure details: Poorvakarma: Patient is asked to pass natural urges and made to sit on knee height chair. Pradhana karma: procedure is done standing behind the patient, different strokes are applied they are smearing the oil, Gharshana hasta, taranga hasta, Mrudu musti tadana, Anguli kreedana, Gatita hasta, Karnabhyanga. each step takes 5 minutes so whole procedure takes 30minutes time. Pashat karma: patients is asked to rest for 15 min and then asked to wash haead after 3 hrs)
(1) Medicine Name: Kantakari phala taila, Reference: Yogaratnakara, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-Siro~aBya~ggaH, शिरोरऽभ्यंग (Procedure Reference: Astanga hridaya, Procedure details: Procedure details: Poorvakarma: Patient is asked to pass natural urges and made to sit on knee height chair. Pradhana karma: procedure is done standing behind the patient, different strokes are applied they are smearing the oil, Gharshana hasta, taranga hasta, Mrudu musti tadana, Anguli kreedana, Gatita hasta, Karnabhyanga. each step takes 5 minutes so whole procedure takes 30minutes time. Pashat karma: patients is asked to rest for 15 min and then asked to wash haead after 3 hrs))
(1) Medicine Name: Japa pushpa taila, Reference: Yoga ratnakara, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Age group between 18 to 60 years.
2)The patients who have signs and symptoms.
3)Patients fit for Shiroabhyanga 
 
ExclusionCriteria 
Details  1)The patients suffering from other type of scalp diseases like Psoriasis, infective conditions will be excluded. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To Evaluate the changes in dryness, Itching sensation.  8th, 15th and 22nd day. 
 
Secondary Outcome  
Outcome  TimePoints 
To Evaluate the changes in hairfall and scaling of scalp.  8th, 15th and 22nd day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   30/03/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 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 DarunakaFrom 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)

 
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