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CTRI Number  CTRI/2024/11/076734 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 09/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Assessment of Pine resin ointment on cracked feet 
Scientific Title of Study   Effect of Sarala-Niryasa Malahara (Pine-resin ointment) on Padadari (cracked feet): A randomized vehicle-controlled 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 Champa Pant 
Designation  Professor & HOD 
Affiliation  Sushrutha Ayurvedic Medical College and Hospital 
Address  OPD no 3, Ground Floor, Sushrutha Ayurvedic Medical College and Hospital
Prashanthi Kuteera Jodi bingipura, Jigani, Anekal Taluka Bangalore, 560105
Bangalore
KARNATAKA
560105
India 
Phone  09986189230  
Fax    
Email  champapantdr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Champa Pant 
Designation  Professor & HOD 
Affiliation  Sushrutha Ayurvedic Medical College and Hospital 
Address  OPD no 3, Ground Floor, Sushrutha Ayurvedic Medical College and Hospital
Prashanthi Kuteera Jodi bingipura, Jigani, Anekal Taluka Bangalore, 560105

KARNATAKA
560105
India 
Phone  09986189230  
Fax    
Email  champapantdr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Champa Pant 
Designation  Professor & HOD 
Affiliation  Sushrutha Ayurvedic Medical College and Hospital 
Address  OPD no 3, Ground Floor, Sushrutha Ayurvedic Medical College and Hospital
Prashanthi Kuteera Jodi bingipura, Jigani, Anekal Taluka Bangalore, 560105

KARNATAKA
560105
India 
Phone  09986189230  
Fax    
Email  champapantdr@gmail.com  
 
Source of Monetary or Material Support  
Sushrutha Ayurvedic Medical College & Hospital, Prashanti Kuteera, Jodi bingipura, Jigani, Anekal Taluka, Bengaluru, Karnataka, India, 560105  
 
Primary Sponsor  
Name  Sushrutha ayurvedic medical college and hospital Bengalore 
Address  Prashanthi Kuteera, Jodi Bingipura, Jigani, Anekal Taluka, Bangalore 560105 
Type of Sponsor  Private medical college 
 
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 Champa Pant  sushrutha Ayurvedic Medical College and Hospital  OPD no 3, Department of Kaumarabhritya, ground Floor, Sushrutha Ayurvedic Medical College and Hospital, Bengaluru Prashanthi Kuteera Jodi Bingipura, Jigni Hobli, Anekal Taluka, Bangalore 560105
Bangalore
KARNATAKA 		 09986189230

champapantdr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SAMC & H-IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L858||Other specified epidermal thickening. Ayurveda Condition: KSHUDRAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Siktha Taila, Reference: Sadananda Sharma, Rasatarangani, hindi commentary, edited by Pandit Kashinatha Shastri, 4th Taranga, Sloka 59-61, Delhi; Motilal Banarasidas; 11th edition, Reprint, 2012. P- 114., Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 20(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugOther than Classical(1) Medicine Name: Sarala Niryasa Malahara, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 20(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Presence of cracked feet skin 
 
ExclusionCriteria 
Details  Presence of any other skin condition
Using any topical preparation for the condition 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Number of days required for complete clearance of Index fissure  1 week,2 week, 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in skin roughness, number and depth of cracks
Changes in pain, burning and itching  		 1 week,2 week, 1 month 
 
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   N/A 
Date of First Enrollment (India)   30/11/2024 
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="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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [champapantdr@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

A very common traditional remedy for Padadaari among rural people of Uttarakhand is application of pure Shrivestaka (resin of Pinus roxburghii) or Sarala Niryasa (called “Leesa” in local language), which is very effective in healing the cracked heels. Charaka in the very first chapter of Charaka Samhita has drawn our attention upon the importance of folkloric medicine and has nudged upon using this untapped knowledge.Sushruta advocates Siravyadha followed by Swedana, Abhyanga and Padalepa prepared out of Madhuchishtha (bee wax), Vasa, Majja, Sarjarasa Niryasa (resin of Vateria indica) with Ghrita.Taking a clue from traditional use of Shrivestaka in Padadaari in folklore and recommendation of Sushrutha for using Niryasa (Sarjarasa ) with Madhuchishtha in Padadaari, a pilot study in 12 patients was done to assess the effectiveness of Sarala Niryasa in Padadaari.  Traditional method of applying Sarala Niryasa directly over heels is very inconvenient due to extremely sticky nature of Sarala Niryasa. Hence, Sarala Niryasa  was used as a Malahara Kalpana (ointment), consisting Madhuchishtha (bee wax) and Tila Taila,  an easy to prepare and apply preparation.

Siktha taila was used as a vehicle to prepare the malahara hence it was taken as a control. Now this study will be done in a bigger sample size of 30 patients each.

 
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