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CTRI Number  CTRI/2025/04/085715 [Registered on: 28/04/2025] Trial Registered Prospectively
Last Modified On: 26/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study on the effectiveness of Trunakadi taila and Khadirarishata for treating ringworm infestation in children  
Scientific Title of Study   Randomized controlled clinical study to evaluate the efficacy of Trunakadi taila and Khadirarishta in Dadru Kushta Dermatophytosis in children  
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 Piyush Popatrao Sonawane 
Designation  PG Scholar 
Affiliation  JSS Ayurveda Medical College And Hospital  
Address  JSS Ayurveda Medical College And Hospital Kaumarabhritya OPD 11 41 E Lalithadripura Road Alanahalli Mysuru 570028

Mysore
KARNATAKA
570028
India 
Phone  8657762410  
Fax    
Email  piyushsonawane1997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Srihari S 
Designation  Professor And Head Of The Department 
Affiliation  JSS Ayurveda Medical College And Hospital  
Address  JSS Ayurveda Medical College And Hospital Kaumarabhritya OPD 11 41 E Lalithadripura Road Alanahalli Mysuru 570028

Mysore
KARNATAKA
570028
India 
Phone  7776077626  
Fax    
Email  Dr.srihari@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Piyush Popatrao Sonawane 
Designation  PG Scholar 
Affiliation  JSS Ayurveda Medical College And Hospital  
Address  JSS Ayurveda Medical College And Hospital Kaumarabhritya OPD 11 41 E Lalithadripura Road Alanahalli Mysuru 570028

Mysore
KARNATAKA
570028
India 
Phone  8657762410  
Fax    
Email  piyushsonawane1997@gmail.com  
 
Source of Monetary or Material Support  
3) Griseofulvin tablet and Terbinafine 1% ointment will be purchased from the local Pharmacy.  
1) Raw material for the preparation of Trunakadi Taila will be procured from the local market after proper identification and authentication by Department of PG studies in Dravyaguna, JSSAMC&H, Mysuru, Karnataka India 570028 and will be prepared in GMP certified pharmacy. 
2) Khadirarishta will be purchased from GMP certified Ayurveda pharmacy. 
 
Primary Sponsor  
Name  Dr Piyush Popatrao Sonawane 
Address  JSS Ayurveda Medical College And Hospital 41/E Lalithadripura Road Alanahalli Mysuru 570028 
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 Piyush Popatrao Sonawane  JSS Ayurveda Medical College And Hospital 41/E Lalithadripura Road Alanahalli Mysuru 570028  JSS Ayurveda Medical College And Hospital Kaumarabhritya OPD 11 41/E Lalithadripura Road Alanahalli Mysuru 570028
Mysore
KARNATAKA 
8657762410

piyushsonawane1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Clearance 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 Arm (Non Ayurveda)-Terbinafine 1%External application for 2 weeks quantity sufficient
2Comparator Arm (Non Ayurveda)-tablet griseofulvin20-25mg/kg/day for 2 weeks in BD dosage
3Intervention ArmDrugClassical(1) Medicine Name: Trunakadi taila, Reference: Vangasena, Route: Topical, Dosage Form: Taila, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information: -
4Intervention ArmDrugClassical(1) Medicine Name: Kadhiraristha, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Arishta, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: Yes(details: water), Additional Information: -
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1 Age group - 3 to 15 years, irrespective of Gender, Religion, and Socio-Economic status.
2 Subjects suffering from infestation of Tinea Carporis and Tinea Cruris.
3 Subjects fulfilling the diagnostic criteria of Dadru Kushta (Dermatophytosis).
 
 
ExclusionCriteria 
Details  1. Patients having chronic infection of Dadru Kushta for more than 3 years.
2. Subjects with any other skin manifestations.
3. Subjects with any other systemic disorders which may interfere with the course of study.
4. Subjects with Tinea Capitis, Tinea Barbae, Tinea Mannum, Tinea Pedis.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the combined effect of Trunakadi Taila external application and Khadirarishta orally in clinical features of Dadru (Dermatophytosis) and quality of life parameters in children.  0th day
8th day
15th day
30th day 
 
Secondary Outcome  
Outcome  TimePoints 
1 To assess the effect of Terbinafine 1% ointment and Griseofulvin orally in clinical features of Dermatophytosis and quality of life parameters in children.
2 To compare the combined effect of Trunakadi Taila and Khadirarishta orally with that of Griseofulvin orally and Terbinafine 1% ointment in clinical features of Dadru (Dermatophytosis) and quality of life parameters in children.
 
0th day
8th day
15th day
45th 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 2/ Phase 3 
Date of First Enrollment (India)   10/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/05/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

According to Acharya Charaka, Kandu (itching), Raga (erythema), reddish coloured Pidaka are in the form of Udgata Mandala (elevated circular lesion) is known as Dadru. Acharya Sushruta has described Dadru as Kapha Pradhana Vyadhi (predominant), and Acharya Vaghbhata and Charaka described it as Pitta Kapha Pradhana Dosha. Lakshanas of Dadru Kushta that is Raukshya, Kandu, Daha, Srava, Mandala. All the clinical features of Dadru can be very well correlated to clinical features of Tinea. Tinea infections are known as dermatophytosis or Ringworm. In Pediatric age group local application is the best line of treatment in mild to moderate ringworm manifestation The antifungal medications available in the market have some adverse effects on the human body. So, there is a need of exploring a safe and effective medicine. In modern medicine, it is treated with topical or systemic antifungal, corticosteroids which gives very fast relief but with high recurrence rate, whereas the systemic and local use of Ayurveda medicine has shown considerable effect in reducing the recurrence rate in Dadru (Tinea).

Dadru Kushta is managed by Shodhana, Shamana and local application. The selected formulation of the present study is Khadirarishta which will be given orally and Trunakadi Taila for external application, as the ingredients of above Yogas possess the properties such as Kushtaghna, Kandughna and Twak Doshahara.

Primary objective of the study To evaluate the combined effect of Trunakadi Taila external application and Khadirarishta orally in clinical features of Dadru (Dermatophytosis). The secondary objective is To compare the combined effect of Trunakadi Taila and Khadirarishta orally with that of Griseofulvin orally and Terbinafine 1% ointment in clinical features of Dadru (Dermatophytosis) and quality of life parameters in children.The study hypothesize that Trunakadi taila and Khadirarishta is as effective as standard care in managing Dadru (tinea)

 

 
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