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CTRI Number  CTRI/2021/09/036195 [Registered on: 03/09/2021] Trial Registered Prospectively
Last Modified On: 01/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Saindhavadi lepa and sindhooradi lepaapplication for the managment of vipadika.  
Scientific Title of Study   “A RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF SAINDHVAADI LEPA IN THE MANAGEMENT OF VIPADIKA’’.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrAkshata Sangolli 
Designation  P.G. Scholar 
Affiliation  sri sri college of ayurvedic science and research. 
Address  room no.r 8 Department of Panchakarma Sri Sri College of Ayurvedic Science and Research Hospital, 21 km udipalya post Bangaluru.
room no.r 8 Department of Panchakarma Sri Sri College of Ayurvedic Science and Research Hospital, 21 km udipalya post Bangaluru.
Bangalore
KARNATAKA
560082
India 
Phone  9480534762  
Fax    
Email  akshataaksha363@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ganesh Puttur 
Designation  HOD and Principal 
Affiliation  sri sri college of ayurvedic science and research. 
Address  room no.r 8,department of Panchakarma.Sri Sri College of Ayurvedic Science and Research hospital Bangalore.21 km udipalya post.
room no.r 8,department of Panchakarma.Sri Sri College of Ayurvedic Science and Research hospital Bangalore.21 km udipalya post
Bangalore
KARNATAKA
560082
India 
Phone  9448176059  
Fax    
Email  drganeshputtur@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ganesh Puttur 
Designation  Principal and HOD department of Panchakarma 
Affiliation  sri sri college of ayurvedic science and research. 
Address  room no.r 8 Department of Panchakarma Sri Sri College of Ayurvedic Science and Research Hospital, 21 km udipalya post Bangaluru.
room no.r 8 Department of Panchakarma Sri Sri College of Ayurvedic Science and Research Hospital, 21 km udipalya post Bangaluru.
Bangalore
KARNATAKA
560082
India 
Phone  9448176059  
Fax    
Email  drganeshputtur@gmail.com  
 
Source of Monetary or Material Support  
room no.r 8 Department of Panchakarma Sri Sri College of Ayurvedic Science and Research Hospital, 21 km udipalya post Bangaluru. 
 
Primary Sponsor  
Name  Akshata sangolli 
Address  Sri Sri College of Ayurvedic Science and Research Hospital Bangalore. 
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 Akshata Sangolli  SRI SRI COLLEGE OF AYURVEDCIS SCIENCE AND RESEARCH HOSPITAL, BENGALURU  Room no. 08, Panchakarma OPD.
Bangalore
KARNATAKA 
9731018686

akshataaksha363@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:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: VIPADIKA,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Saindhavadi Lepa  After cleaning the affected area with hot water, apply the Saindhavadi Lepa and leave it for 6 hours, wash it in the morning with hot water 
Comparator Agent  Sindhooradi Lepa  After cleaning the affected area with hot water, apply the Sindhooradi Lepa and leave it for 6 hours, wash it in the morning with hot water 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Subjects aged between 21 - 65 years, irrespective of gender, caste, occupation,
socio-economic status.
Subjects with complaints of cracked foot and palm.
Subjects willing to give written consent. 
 
ExclusionCriteria 
Details  Pregnant and lactating women.
Subjects having systemic diseases like Diabetic foot, Plantar psoriasis, Cellulitis,
Eczema, Contact dermatitis and other skin diseases.
Subjects with excessive hardening of the margins of palms and foot. 
 
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   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
reduction in number of cracks of foot and reduction of pain in the foot.   0th,10th and 20th day.  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   11/09/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Skin is a dress that one wears for lifetime which plays very important role from protection to cosmetic. As it comes first in contact with environment it is the first barrier of protection from physical, chemical and biological agents. Therefore, diseases of this organ become great deal of misery, mainly because it is visible.

 

In Ayurveda all the diseases of skin are dealt under the heading of kushta, in other words it can be known as “Ayurvedic dermatology. Kushta are mainly divided into two groups i.e. Maha kushta and Kshudra kushta. Among the number of kushta, Vipadika falls under kshudra kushta. It is characterized by sphutana either in palms or soles or in both with teevra vedana. It is most commonly found issue in the present world as the incidence rate is found to be 58.4%. When the condition of Vipadika is neglected it affects the living condition of one’s life as it becomes portal entry for the organisms and can cause many inflammatory diseases like lymphangitis, eczema, cellulitis etc.

By looking at the symptoms, this disease can be co-related with palmoplantar psoriasis, palmoplantar keratoderma,  palmoplantar xerosis, palmoplantar dermatophyte, fissures of heel and palm, eczema of hands and foot.

In the contemporary science, the treatment of cracked foot is Keratolytic (salicylic acid), paraffin, petroleum gel etc.These above-mentioned medications give temporary relief and fail to minimize the recurrence. Hence, the need for formulations which gives quick, prolonged and better result is required.

Since every sector in this globalized world has a busy lifestyle, therefore treatment aspects should be convenient considering the busy lifestyle. Lepa is one such convenient method of treatment. As we all know snehana is the best mode of treatment for vata and Vipadika is one among vataja nanatmaja vyadi. Hence lepa which has snehana properties is selected, by keeping it in mind and by looking into the ingredients of saindhavadi lepa as it contains many of the sneha dravyas like taila, sarpi, etc.an effort is made to evaluate its efficacy in the management of Vipadika in the present study.

 
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