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CTRI Number  CTRI/2023/05/052676 [Registered on: 16/05/2023] Trial Registered Prospectively
Last Modified On: 11/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study to evaulate the efficacy of Dadrughna Lepa in Fungal Dermatophytosis. 
Scientific Title of Study   A Randomized open labelled controlled clinical study to evaulate the efficacy of Dadrughna Lepa in the management of Dadu Kushta with special reference to Fungal Dermatophytosis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr VISHNU S 
Designation  PG SCHOLAR 
Affiliation  SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL, BENGALURU  
Address  ROOM NO 304,DEPARTMENT OF PG STUDIES IN KAYACHIKITSA, SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH, BENGALURU

Bangalore
KARNATAKA
560076
India 
Phone  9535417658  
Fax    
Email  vishnu07997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SOWMYASHREE U P 
Designation  ASSOCIATE PROFESSOR 
Affiliation  SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL, BENGALURU  
Address  ROOM NO 304,DEPARTMENT OF PG STUDIES IN KAYACHIKITSA, SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH, BENGALURU

Bangalore
KARNATAKA
560082
India 
Phone  9743893056  
Fax    
Email  upsprasad@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr VISHNU S 
Designation  PG SCHOLAR 
Affiliation  SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL, BENGALURU  
Address  ROOM NO 304,DEPARTMENT OF PG STUDIES IN KAYACHIKITSA, SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH, BENGALURU

Bangalore
KARNATAKA
560076
India 
Phone  9535417658  
Fax    
Email  vishnu07997@gmail.com  
 
Source of Monetary or Material Support  
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH 
 
Primary Sponsor  
Name  Dr VISHNU S 
Address  ROOM NO 304,DEPARTMENT OF PG STUDIES IN KAYACHIKITSA, SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH, BENGALURU 
Type of Sponsor  Other [SELF] 
 
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 
Dr VISHNU S  SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL  ROOM NO 05 DEPARTMENT OF KAYACHIKITSA SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL BANGALORE
Bangalore
KARNATAKA 
9535417658

vishnu07997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SRI INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:B354||Tinea corporis. Ayurveda Condition: DADRU-KUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: DURVADI PRALEPA, Reference: VRUDDHA VAGBHATA CHIKITSA STHANA KUSHTA ROGA ADHIKARA, Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: TAKRA), Additional Information: INGREDIENTS ARE DURVA,HARITAKI,SAINDAVALAVANA,CHAKRAMARDA,THULASI.LOCAL APPLICATION WITH  TAKRA IN REQUIRED QUANTITY (TAKRA TO BE KEPT OVERNIGHT SHOULD BE USED).ONCE DAILY MORNING, TO BE REMOVED BEFORE GETTING DRIED AND WASHED WITH LUKEWARM WATER
2Intervention ArmDrugClassical(1) Medicine Name: DADRUGHNA LEPA, Reference: BHAVAPRAKASHA MADHYAMA KHANDA KUSHTA ROGA ADHIKARA, Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: TAKRA), Additional Information: INGREDIENTS ARE KUSTHA,VAYA VIDANGA,CHAKRAMARDA,HARIDRA,SAINDAVA LAVANA AND RAJIKA. LOCAL APPLICATION WITH  TAKRA IN REQUIRED QUANTITY (TAKRA TO BE KEPT OVERNIGHT SHOULD BE USED).ONCE DAILY MORNING, TO BE REMOVED BEFORE GETTING DRIED AND WASHED WITH LUKEWARM WATER
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  SUBJECTS FALLING UNDER B36 OF ICD10 CLASSIFICATION,CLINICAL SIGNS AND SYMPTOMS OF DADRU KUSHTA AS DESCRIBED IN CLASSICAL TEXTS (PRESENCE OF UDGATA MANDALA WITH OR WITHOUT OTHER SYMPTOMS),SUBJECTS WILLING TO PARTICIPATE IN THE STUDY WITH WRITTEN INFORMED CONSENT WHICH IS CONVEYED IN THE LANGUAGE WHICH THE SUBJECT CAN UNDERSTAND 
 
ExclusionCriteria 
Details  PREGNANT AND LACTATING WOMEN.
SUBJECTS HAVING ANY UNCONTROLLED SYSTEMIC ILLNESS WHICH CAN INTERFERE WITH THE COURSE OF DISESASE AND TREATMENT,
OTHER OVERLAPPING DERMATOLOGICAL DISEASES WILL BE EXCLUDED,
SUBJECTS UNDER ANTI-FUNGAL DRUGS WILL BE EXCLUDED. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in KASI score  before intervention-0th day
during intervention-10th day
after intervention-21st day
follow up-28th day 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/06/2023 
Date of Study Completion (India) 03/06/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
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 the human body. Its size and external location make it susceptible to a wide variety of disorders.In recent years, there has been a considerable increase in the incidence of skin conditions in the tropical and developing countries like india.Skin disorders are known to be the fourth most common causes of all human diseases affecting nearly 1/3rd of population in the world.All the skin diseases are explained under the heading of Kushta in Ayurveda. Dadru Kushta is one of the commonly occurring skin disease and is KaphaPitta predominant.ED-4.3.6 specific code that can be used to indicate the Dadru Kushta as mentioned in NAMASTE PORTAL (National Ayush Morbidity and standardised terminologies electrical portal).The symptoms like Durvavat deerghapradhana indicates its spreading nature, Athasi indicates its coppery red colour, Kandu(itching) and Anushangini its chronic nature.Most of the features of Dadru Kushta is similar to the features of dermatophytosis.Dermatophytosis is the fungal infection of the skin.It can be developed from 40 types of fungi, of which dermatophytes trichophyton,microsporum and epidermophyton are the common causative agents.B5.9 is a specific ICD-10-CM code to indicate the diagnosis of Dermatophytosis.The typical clinical presentation of this disease is red, itchy and scaly circular lesion.Globally,up to 20% of the human population may be infected by dermatophyte at a time. The last few years shows a significant rise in the incidence of chronic Dermatophyte infections of skin,which have been proven difficult to treat.In contemporrary medical science, management of Dermatophytosis is carried out with Topical fungicidal agents like natamycin, clotrimazole, econazoles, miconazoles etc and systemic anti-fungal agents like Griseofulvin, Ketocenazole are advocated. Systemic fungicidal are highly toxic.Topical fungicidal require prolonged application and recurrence poses a problem in addition to appearance of resistance and long lasting usage produce the adverse effect like flaking of skin, irritation, redness etc.Hence,there is a need to contribute with safe and cost effective remedy in management of Dadru Kushta to effectively manage the disesase and not to cause any ill effects on body.In Ayurveda,many effective formulations without side effects are available. A series of studies conducted in recent past comprising of  topical applications have showed mild to moderate response in Dadru Kushta. Here arises the importance of unique formulation in the management of Dadru Kushta. 

 
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