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CTRI Number  CTRI/2024/07/069821 [Registered on: 02/07/2024] Trial Registered Prospectively
Last Modified On: 01/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical study to see the effect of Suvarnakadi yoga in the management of Fungal infection. 
Scientific Title of Study   An open clinical study to evaluate efficacy of Suvarnkadi yoga in the management of Dadru with special reference to Tinea Carporis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr.Snehal Bhagwat Patil 
Designation  PG Scholar 
Affiliation  R.A.Podar Ayurvedic Hospital Worli Mumbai-18 
Address  R.A.Podar Ayurvedic Hospital near dr.annie besant road Worli Mumbai Pincode-400018 Kayachikitsa Department Ground Floor OPD No.19

Mumbai
MAHARASHTRA
400018
India 
Phone  9421514742  
Fax    
Email  vd.snehalpatil1995@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Mukund Dinkararao Magare 
Designation  Associate Professor  
Affiliation  R.A.Podar Ayurvedic Hospital Worli Mumbai-18 
Address  R.A.Podar Ayurvedic Hospital Near, dr. Annie Basant besant road Worli Mumbai Pincode-400018 Kayachikitsa Department,Ground Floor OPD No 19


MAHARASHTRA
400018
India 
Phone  9221221169  
Fax    
Email  mukundmagare@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrSnehal Bhagwat Patil 
Designation  PG Scholar 
Affiliation  R.A.Podar Ayurvedic Hospital Worli Mumbai-18 
Address  R.A.Podar Ayurvedic Hospital Near,dr.Annie Besant Road Worli Mumbai-18 Pincode-400018 at Kayachikitsa Department Ground Floor OPD No 19


MAHARASHTRA
400018
India 
Phone  9421514742  
Fax    
Email  vd.snehalpatil1995@gmail.com  
 
Source of Monetary or Material Support  
M.A.Podar Ayurvedic Hospital Worli Mumbai-18 
 
Primary Sponsor  
Name  RAPodar Ayurvedic Hospital  
Address  R.A.Podar Ayurvedic Hospital worli mumbai-18,Near,dr.Annie Besant Road Worli Mumbai-18, Pin-400018 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
MAPodar Ayurvedic Hospital Worli Mumbai  R.A.Podar Ayurvedic Hospital Worli Mumbai-18,Near, dr.Annie Besant Road Worli Mumbai, Pin-400018 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSnehal Bhagwat Patil  R.A.Podar Ayurvedic Hospital   R.A.Podar Ayurvedic Hospital Worli Mumbai-18,near dr.Annie Besant Road Worli Mumbai-18,Pin-400018 Kayachikitsa Department Ground Floor OPD No 19
Mumbai
MAHARASHTRA 
9421514742

vd.snehalpatil1995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BORS Committee of the institution R.A.Podar ayurvedic medical College worli mumbai   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: DADRU-KUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Suvarnakadi yoga, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: We have selected Suvarnakadi yoga which contains 4 drugs 1 Aaragwadha 2 Chakramarda 3 Guduchi 4 Khadira Suvarnakadi yoga is swanubhut yog drugs in suvarnakadi yoga are selecthed seperately throgh bhavaprakasha nighantu these all drugs have kushthaghna property
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with sign and symptoms of Dadru like kandu,pidika,vaivarnya and mandala.

Understanding and being willing to sign the informed concent form 
 
ExclusionCriteria 
Details  Patient having skin lesion other than dadru kushtha(Tinea corporis)like eczema,psoriasis,urticaria.
Pregancy and lactating mother.
Immuno-compromised patients like AIDS,HbsAg positive etc.
Person with sever disorder like CA,liver disease,renal or cardiac problems,bed ridden due to chronic illness.
Patient having uncontrolled DM/HTN.
Any complication arising during the treatment of any patient discontinuing tratmrnt will be excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To see the effect of suvarnakadi yoga in reducing the symptoms of tinea carporis like itching, discolouration,boils and patches  28 days
Follow up every week at 1st,2nd,3rd,4th week. 
 
Secondary Outcome  
Outcome  TimePoints 
To study the role of suvarnakadi yoga in reducing itching,boils, discolouration, in dadru(tinea Carporis).
Maximum longitudinal length & horizontal length area will be calculated before & after using butter paper & graph papaer.
To study the formulation of suvarnakadi yoga.
To assess the acceptability & saftey of suvarnakadi yoga.
To study the disease dadru with ayurveda & modern aspect with tinea corporis. 
28 days
Follow up every week at 1st,2nd,3rd,4th week. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 3 
Date of First Enrollment (India)   15/07/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Skin is the largest organ of human body. Its size and external location makes it susceptible to a wide variety of disorders. In recent years there has been increase in incidence of skin problem due to various reasons like Poverty, Poor sanitation, Unhygienic condition, Pollution, Diwaswap’, vegavidharana, virudhashana", Stress etc. Skin diseases creates an emotional concern for an individual which includes embarrassment, low self esteem, anxiety, depression and shame.

In Ayurveda the word ’kushtha is broad term which covers almost all skin disorders. Acharya Charaka has described 18 types of kushtha rogas which then classified into 7 types of Mahakushtha and 11 types of Kshudra Kushtha, Dadru’ is among these Kshudra Kushtha while according to Acharya sushruta it is Mahakushtha".

Dadru is a tridoshaj twak vikara with Pitta-Kapha predominance". Acharya Charaka has described Dadru Kushtha under 4 th layer of the Twacha. It involves clinical features like Kandu, Raga, Pidika, Mandala¹

सराग कण्डू पिडकं दद्रु मण्डलमुद्गतम् ॥ च. चि.७/३३।

These symptoms are very much similar with the features of ’Tinea Carporis’ means highly contagious fungal infection spreading all over the body etc. Through modern perspective it comes under the superficial fungal infection of skin caused by the keratinophilic fungi. Tinea Carporis involves body, arms, and legs etc. It is common skin disease in India with prevalence rate of superficial mycotic infection worldwide has been found 20-25%."

Shodhana is very much time consuming process and requires proper samsarjan krama palana (means proper pathya palana) also lepana chikitsa is time consuming. In this modern era people are busy in their schedules so they don’t have time for shodhana and lepa chikitsa and they seek option for that. So there is a need of better shamana chikitsa which acts on rasavaha, raktavaha and mansavaha strotasa". Because Shata Twacha is konwn as Updhatu of Mans dhatu.

For that I have formulated" Suvarnakadi Yoga". In Dadru

kledaghna, Kandughna, kaphaghna, varnyakara, raktashodhniya chikitsa is required and
Suvarnakadi yoga contains Aragwadha, Chakramarda, Guduchi, Khadira. Kleda is basic cause for kushtha so for samprapti bhanga main aim of treatment is to reduced kleda. In " Suvarnakadi Yoga" Khadira has kledghna property due to ruksha, laghu, sheet Guna. It has raktashodhana property due to tikta, Kashay rasa Chakramarda has katu rasa, laghu ruksha guna basically acts as kledaghna and kapha-pittashamak. Guduchi has tikta rasa which work on raktavaha strotasa. Yakruta and pilha are moolasthana of raktavaha strotasa". It has yakrit gamitva effect which is important for treatment of Dadru. According to Aacharya Bhavprakasha Aragwadha is sransana drvya which acts on koshtha and helps in samprapti bhanga of dadru kushtha by reducing the kleda in the koshtha.

Taking all above consideration in my mind I have selected this topic.

"AN OPEN CLINICAL STUDY TO EVALUATE EFFICACY OF ’SUVARNAKADI YOGA’ IN THE MANAGEMENT OF DADRU WITH SPECIAL REFERENCE TO TINEA CARPORIS."
 
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