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CTRI Number  CTRI/2021/12/038862 [Registered on: 23/12/2021] Trial Registered Prospectively
Last Modified On: 22/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   study of Nimbapatolpatra Kashaya –Aaragwadhapatra lepa With Aaragwadhavrukshak Kashaya- Aaragwadhapatra lepa in Tinea. 
Scientific Title of Study   A comparative clinical trial study to evaluate combined effect of Nimbapatolpatra Kashaya –Aaragwadhapatra lepa With Aaragwadhavrukshak Kashaya- Aaragwadhapatra lepa in Dadru. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ABHINAV RAVINDRA SONTAKKE 
Designation  PG scholar 
Affiliation  MAMs Sumatibhai Shah Ayurved College 
Address  OPD NO 2 Kayachikitsa dept ground floor Sane Guruji Arogya Kendra, Malawadi, Hadapsar, Pune
OPD NO 2 Kayachikitsa dept ground floor Sane Guruji Arogya Kendra, Malawadi, Hadapsar, Pune
Pune
MAHARASHTRA
P2A66
India 
Phone  9561270968  
Fax    
Email  sontakke.abhinavs@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jayashree N Tongaonkar 
Designation  Professor 
Affiliation  MAMs Sumatibhai Shah Ayurved College 
Address  OPD NO 2 Kayachikitsa dept ground floor Sane Guruji Arogya Kendra, Malawadi, Hadapsar, Pune
OPD NO 2 Kayachikitsa dept ground floor Sane Guruji Arogya Kendra, Malawadi, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India 
Phone  9822829493  
Fax    
Email  jntayu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhinav Ravindra Sontakke 
Designation  PG scholar 
Affiliation  MAMs Sumatibhai Shah Ayurved College 
Address  OPD NO 2 Kayachikitsa dept ground floor Sane Guruji Arogya Kendra, Malawadi, Hadapsar, Pune
OPD NO 2 Kayachikitsa dept ground floor Sane Guruji Arogya Kendra, Malawadi, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India 
Phone  9561270968  
Fax    
Email  sontakke.abhinavs@gmail.com  
 
Source of Monetary or Material Support  
MAM Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi Hadapsar, Pune 
 
Primary Sponsor  
Name  Dr Abhinav Sontakke 
Address  OPD NO 2 Kayachikitsa dept ground floor Sane Guruji Arogya Kendra, Malawadi, Hadapsar, Pune 
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 Abhinav Ravindra Sontakke  Sane Guruji Aarogya Kendra,  OPD NO.2, Kayachikitsa Department, MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune
Pune
MAHARASHTRA 		 9561270968

sontakke.abhinavs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DADRU-KUSHTHAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Aaragwadhavrukshak Kashaya- Aaragwadhapatra lepa  Aaragwadhavrukshak Kashaya- 20 ml twice a day with anupan koshna jala Aaragwadhapatra lepa- pralep 
Intervention  Nimbapatolpatra Kashaya –Aaragwadhapatra lepa  Nimbapatolpatra Kashaya – 20 ml twice a day with anupan koshna jala Aaragwadhapatra lepa - pralep 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients presenting with classical signs & symptoms of Dadru.
The patients of both gender irrespective of caste,socio-economic status,religion, community, etc.
Age group between 20-60 years.
Washout period for previous medicine (Ex.Antifungal drugs,etc.) is of 15 days. 
 
ExclusionCriteria 
Details  Patient on steroid treatment.
Extensive Tinea.
Tinea more than 2 years
Tinea associated with other skin diseases.
Tinea Unguium and Tinea Incognito.
HIV infective patient. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare combined effect of “Nimbapatolpatra kashya –Aaragvadgapatralepa” with “ Aaragvadhavrukshak kashaya – Aaragvadhapatra lepa” in Dadru.  5 days 
 
Secondary Outcome  
Outcome  TimePoints 
to compare combined effect of Nimbapatolpatra kashay- aaragwadhpatra lepa with aaragwadhvrukshak kashay-aaragwadhpatra lepa in dadru  40 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 
Date of First Enrollment (India)   23/12/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   To be published in peer reviewed journal after completion of clinical trial. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Title-A comparative clinical trial study to evaluate combined effect of “Nimbapatolpatra Kashaya –Aaragwadhapatra lepa ” With “Aaragwadhavrukshak Kashaya- Aaragwadhapatra lepa”in Dadru.

 Skin diseases are mainly caused by the involvement of several micro organism  where Tinea is one among them. Tinea/Ringworm infection is caused by a distinct class of fungi.  They thrive in keratin layer of the epidermis, nails and hair. However, they do not invade the  living epidermis. The serum fungal inhibitory factors in the extra vascular space prevent the  penetration of the fungi in the living tissue. Several factors such as poor nutrition, unhygienic  conditions, hot and humid climate, vocation promoting sweating and maceration, Diabetes  mellitus, debilitating diseases, administration of corticosteroids and immunosuppressive  agent,close and intimate contact with infected persons, animals and fomites predispose to  ringworm infection. It should be noted that 10-15% of the general practitioners work with skin  disorders. 5 out of 1000 people are suffering from Tinea infection. In contemporary Medical science, management of Tinea is carried out with usage  of topical or systemic antifungal, corticosteroids. Long lasting usage produce the adverse  effect also. Possible palliative treatment is with Ayurveda, which is effective. Since long year ago,major emphysis given on topical treatment by local applications of  various drugs. But it seems that only topical treatment is unsatisfactory. This is an attempt to treat Tinea by giving systemic regimens and to find which drug  work with great efficacy. Now in this era,there is large numbers of patients having skin  disease and their number is increases day by day. In Charak Chikitsasthan, adhyay no.7 explains all about “Kushtha.”and also that  Nimbapatolpatra and aragvadhavrukshaka are kushthaghna property.So here an attempt to  study on Dadru with title “A comparative clinical study to evaluate combined effect of  “Nimbapatolpatra Kashaya –Aaragwadhapatra lepa ” With “Aaragwadhavrukshak  Kashaya- Aaragwadhapatra lepa”in Dadru.Due to this reason,this topic is  selected.
 
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