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CTRI Number  CTRI/2024/04/065927 [Registered on: 18/04/2024] Trial Registered Prospectively
Last Modified On: 16/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Bilwadi agada followed by Nalpamaradi oil tropical application in fungal infection 
Scientific Title of Study   Effect of topical application of bilwadi agada followed by nalpamaradi taila in dadru wsr to tinea corporis: an open labelled clinical trial 
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 Sushma Ghoolappa Kanavi 
Designation  Pg Scholar dept of agada tantra 
Affiliation  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi 
Address  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi Agada tantra department OPD NO 16

Belgaum
KARNATAKA
590003
India 
Phone  9513460380  
Fax    
Email  drsushmakanavi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rudramma R Hiremath 
Designation  Professor and HOD PG Department of Agada Tantra Evum Vidhivaidyaka 
Affiliation  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi 
Address  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi Agada tantra department OPD NO 16

Belgaum
KARNATAKA
590003
India 
Phone  9480539098  
Fax    
Email  drrrhiremath99@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rudramma R Hiremath 
Designation  Professor and HOD PG Department of Agada Tantra Evum Vidhivaidyaka 
Affiliation  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi 
Address  KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi Agada tantra Department OPD NO16


KARNATAKA
590003
India 
Phone  9480539098  
Fax    
Email  drrrhiremath99@gmail.com  
 
Source of Monetary or Material Support  
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi 
 
Primary Sponsor  
Name  Dr Sushma Ghoolappa Kanavi 
Address  KAHREs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi 
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 Sushma Ghoolappa Kanavi  KLE Ayurveda hospital and medical research center agada tantra department OPD NO 16  Agada Tantra department opd no 16
Belgaum
KARNATAKA 
9513460380

drsushmakanavi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committe for research on human subjects KAHEs Shri B M Kankanawadi ayurveda mahavidyalaya and KLE ayurved hospital shahapur Belagavi   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: DADRU-KUSHTHAH, (2) 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 ArmDrugClassical(1) Medicine Name: bilwadi agada, Reference: ashtanga uttara sthana 36 chapter84 to 85 shloka, Route: Topical, Dosage Form: Lepa Gutika, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: -total 21 days study in that first 10 days we give bilwadi agada followed by nalpamaradi taila for topical application after 10 days only nalpamardi taila for topical application
(2) Medicine Name: nalpamaradi taila, Reference: sahastrayoga taila yoga prakarana 26 and AFI volume 1, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: -total 21 days study in that first 10 days we give bilwadi agada follo
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient diagnosed with Tinea corporis
Patients aged between 18 to 60 years
Irrespective of sex
Positive mycological findings of less than 30 Percentage of the body surface involvement will be recruited for the study
 
 
ExclusionCriteria 
Details  Patients undergoing antifungal treatment
Generalized skin conditions such as herpes zoster urticaria pemphigus and psoriasis
Patient with Diabetes mellitus and uncontrolled hypertension
Systemic diseases RA Liver and renal dysfunction
Patient with the treatment of phototherapy and corticosteroids
Hypersensitive patients
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
primary outcome- decrease in fungal load from 0th day to 21st day  0th 11th and 21st day 
 
Secondary Outcome  
Outcome  TimePoints 
KANDU Itching
RAGA Erythema
PIDAKA Eruption
ROOKSHATA Dryness
UTSANNA MANDALA Elevation of lesion
 
oth 11th & 21st day 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/05/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

Dermatophyte is a common label for a group of fungus of Arthrodermataceae family that commonly causes skin infection in humans and animals. Fungal skin infection can be superficial or less commonly deep; the latter are seen more often in tropical climates or in the immunocompromised. Dermatophyte infections are extremely common and usually caused by the fungi of the Microsporum, Trichophyton and Epidermophyton species. The fungi can originate from soil(geophilic) or animals(zoophilic) or be confined to human skin(anthropophilic).  

TINEA CORPORIS

The site of infection is typically on exposed skin unless the infection represents an extension of a pre-existing infection. In such cases, infection may spread from the scalp, down the neck onto the upper trunk, or from the groins onto the buttocks and lower trunk. Characteristics lesions are circular, usually sharply emarginated with a raised edge. Single lesions occur or there may be multiple plaques. The latter may remain discrete or become concrescent. The degree of inflammation is roughly proportional to the extent of follicular invasion, thus tinea corporis is generally less inflammatory than tinea capitis or tinea barbae. In quieter infections scaling is common but not a constant finding. Sometimes pustules or vesicles may dominate. Central resolution in the lesions may occur but not an invariable feature of tinea corporis.

 
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