FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/02/040587 [Registered on: 24/02/2022] Trial Registered Prospectively
Last Modified On: 23/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Use of Ayurvedic Medicines in skin disease 
Scientific Title of Study   RANDOMISED CONTROLLED CLINICAL STUDY OF AROGYAMISHRAN AND TANKANAMISHRAN IN DADRU W.S.R. TO TINEA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suryakiran Parashuram Wagh 
Designation  Professor 
Affiliation  Parul University Vadodara Gujarat 
Address  Room No. 17, Kayachikitsa OPD, Ground floor, At Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA

Kolhapur
MAHARASHTRA
416114
India 
Phone  09822846910  
Fax    
Email  suryakiran_wagh@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suryakiran Parashuram Wagh 
Designation  Professor 
Affiliation  Parul University Vadodara Gujarat 
Address  Room No. 17, Kayachikitsa OPD, Ground floor, At Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA

Kolhapur
MAHARASHTRA
416114
India 
Phone  09822846910  
Fax    
Email  suryakiran_wagh@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suryakiran Parashuram Wagh 
Designation  Professor 
Affiliation  Parul University Vadodara Gujarat 
Address  Room No. 17, Kayachikitsa OPD, Ground floor, At Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA

Kolhapur
MAHARASHTRA
416114
India 
Phone  09822846910  
Fax    
Email  suryakiran_wagh@rediffmail.com  
 
Source of Monetary or Material Support  
Yashawant Dharmarth Rugnalaya, Kodoli, Tal Panhala, Dist Kolhapur , Maharashtra 
 
Primary Sponsor  
Name  Dr Suryakiran Parashuram Wagh 
Address  Yashwant Ayurved College Post graduate Training and Research Centre Kodoli 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Suryakiran Parashuram Wagh  Yashwant Ayurved College Post graduate Training and Research Centre Kodoli 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shailesh Deshpande  Parul Ayurved Hospital  OPD no.116, Kayachikitsa Department, Parul Ayurved Hospital At Limda, Tal Waghodia, Dist. Vadodara, Gujarat 391760
Vadodara
GUJARAT 		 9763104451

dr.shaileshd@gmail.com 
Dr Suryakiran Parashuram Wagh  Yashwant Dharmarth Rugnalaya   Room No. 17, Kayachikitsa OPD, Ground floor, At Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA 		 9822846910

suryakiran_wagh@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee Parul Institute Of Ayurved Parul University  Approved 
Yashwant Ayurved College Post Graduate Training and research Centre Kodoli IEC  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)-controlled groupCap Itraconazole 200mg once a day , application of Ketoconazole 2% cream twice a day for 15 days
2Intervention ArmDrugClassical(1) Medicine Name: Arogyavardhini , Reference: Rasaratnasamuchchyaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Manjishthadi Kwath), Additional Information:
3Intervention ArmDrugClassical(1) Medicine Name: Gandhak Rasayan, Reference: Yogratnakar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information:
4Intervention ArmDrugClassical(1) Medicine Name: Nimba choorna, Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information:
5Intervention ArmDrugClassical(1) Medicine Name: Gandhak Choorna, Reference: Rasaratnasamuchchyaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information:
6Intervention ArmDrugClassical(1) Medicine Name: Gandhak Druti, Reference: Vangasen Samhita, Route: Oral, Dosage Form: Taila, Dose: 2(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Milk), Additional Information:
7Intervention ArmProcedure-lepa, लेप (Procedure Reference: Sharangdhar Samhita, Procedure details: Tankan choorna and Gandhak Choorna lepa in water will be applied)
(1) Medicine Name: Tankan choorna and gandhak choorna, Reference: Rasatarngini andrasaratna samuchchyaya, Route: Topical, Dosage Form: Lepa Churna, Dose: 1(g), Frequency: bd, Duration: 15 Days
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having the clinical features of dadru.
Patients ready to abide trial procedure to give
informed consent.  
 
ExclusionCriteria 
Details  1. Patients aged below 14 & above 60 years.
2. Pregnant women & lactating mothers.
3. Patient of other skin disease like psoriasis, seborrhic
dermatitis, lichen simplex, chronicus, pityriasis
versicolor, eczema, candidiasis.
4. Patients having any known severe systemic diseases of renal,
hepatic cardiac disorders, diabeties mellitus,
tuberculosis, immuno deficiency syndrome, leprosy,
malignant disease.
5.Patients having known drug allergy of sulphur, mercury.  
 
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 
Cure of Dadru kushta signs and symptoms Kandu (Pruritus)
Raga (Erythema)
Number of Mandala
Size of Mandala 		 2 months 
 
Secondary Outcome  
Outcome  TimePoints 
no recurrence of Dadru  4 weeks 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   01/03/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/03/2022 
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 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   Background of study is that Dadru wsr Tinea infections recurrence is high, there is need of long standing solution to avoid the recurrence of the disease. This is randomised controlled open clinical trial. both arms with 60 patients intervention for 15 days. Expected primary outcome is patients will became sign and symptom free and secondary outcome will that there should not be recurrence for 6 months. 
Close