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CTRI Number  CTRI/2025/02/080705 [Registered on: 17/02/2025] Trial Registered Prospectively
Last Modified On: 17/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of kanakadi lepa with or without blood letting therapy in cracked foot. 
Scientific Title of Study   A Randomised Comparative Clinical Study to Determine the Effect of Kanakadi lepa with and without Siravyadha in Padadari. 
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 Amol Pawar 
Designation  PG Scholar 
Affiliation  A L N Rao Memorial Ayurvedic Medical college and P.G. Center, Kopp 
Address  Department of Kayachikitsa,1st floor, A L N Rao Memorial Ayurvedic Medical college and P.G. Centre, Koppa-577126, Chikmagalur Dist, Karnataka.

Chikmagalur
KARNATAKA
577126
India 
Phone  9119505578  
Fax    
Email  pawaramol808@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Keshava D V 
Designation  Professor 
Affiliation  A L N Rao Memorial Ayurvedic Medical college and P.G. Center, Kopp 
Address  Department of Kayachikitsa,1st floor, A L N Rao Memorial Ayurvedic Medical college and P.G. Centre, Koppa-577126, Chikmagalur Dist, Karnataka.

Chikmagalur
KARNATAKA
577126
India 
Phone  9880031849  
Fax    
Email  keshavamdkc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amol Pawar 
Designation  PG Scholar 
Affiliation  A L N Rao Memorial Ayurvedic Medical college and P.G. Center, Kopp 
Address  Department of Kayachikitsa,1st floor, A L N Rao Memorial Ayurvedic Medical college and P.G. Center, Koppa-577126, Chikmagalur Dist, Karnataka.

Chikmagalur
KARNATAKA
577126
India 
Phone  9119505578  
Fax    
Email  pawaramol808@gmail.com  
 
Source of Monetary or Material Support  
Department of kayachikitsa, 1st floor, ALN Rao Memorial Ayurvedic Medical College, koppa , Chikmagaluru Dist, 577126. 
 
Primary Sponsor  
Name  Dr Amol Pawar 
Address  Department of kayachikitsa, 1st floor, ALN Rao Memorial Ayurvedic Medical College, koppa , Chikmagaluru Dist, 577126. 
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 Amol Pawar  ALN Rao Memorial Ayurvedic medical college hospital  P.G Department of Kayachikitsa room no 01, A L N Rao Memorial Ayurvedic Medical College hospital, Koppa, Chikmagalur Dist, 577126.
Chikmagalur
KARNATAKA 		 9119505578

pawaramol808@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Aroor Laxminarayana Rao Memorial AYURVEDIC MEDICAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L989||Disorder of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: PADADARI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-lepa, लेप (Procedure Reference: Bhaishajya kalpana, Procedure details: Method of application of Lepa: POORVAKARMA: 1.Lepa will be kept ready. 2.Foot will be cleaned properly. 3.Patients will be made to sit comfortably. PRADHANA KARMA: 1.Evenly Kanakadi Lepa will be applied over the foot. 2.Thickness of lepa will be 4-5 mm approximately. 3.Kept till it dries up. PASCHATKARMA: 1.Foot will be washed with lukewarm plain water thoroughly. )
(1) Medicine Name: kanakadi lepa, Reference: Bharata Bhaishajya Ratnakara, Route: Topical, Dosage Form: Lepa Churna, Dose: 30(g), Frequency: od, Duration: 15 Days
2Comparator ArmProcedure-sirAvedhaH, सिरावेधः (Procedure Reference: Bhaisajya Ratnavali, Procedure details: POORVAKARMA: 1.Padabhyanga was done on full area of skin below ankle joint on both dorsal and ventral aspects with Tila taila. 2.Nadi sweda will be given locally after padabhyanga. COLLECTION OF REQUIRED MATERIALS 1.Scalp vein set 21 No, measuring jar, bandage cloth, kidney tray, surgical gloves, gauze, cotton, tourniquet. 2.Patient will be made to sit comfortably. 3.A tourniquet will be applied above the ankle joint. 4.Selection of vein will be done. Properly visualized, prominent and straight medial marginal vein will be selected. PRADHANA KARMA: 1.Cleaning the site of Siravyadha will be done with spirit swab. 2.Taping the vein will be done to make it more prominent. 3.The needle will be inserted in to the medial marginal vein. 4.Confirm the free flow of the blood through the needle. 5.The blood will be collected in a measuring jar. 6.30 ml of blood will be drawn. 7.Amount of blood flown out will be measured and noted. )
(1) Medicine Name: kanakadi lepa, Reference: Bharata Bhaishajya Ratnakara, Route: Topical, Dosage Form: Lepa Churna, Dose: 30(g), Frequency: od, Duration: 15 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Age group - 18yrs - 70yrs.
2.Subjects with fissures/ cracks in heel will be included irrespective of sex, economic status and religion.
3.Subjects with signs and symptoms of Padadari as mentioned in classical & contemporary texts such as ruja (pain), dari (cracks), kandu (itching), rukshata (dryness), daha (burning sensation).
4.The depth of the dari should be less than or equal to 1.5mm.
5.Subjects must be capable of giving consent, willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures.
 
 
ExclusionCriteria 
Details  1.Subjects with chronic systemic illnesses like uncontrolled Diabetes mellitus, hypertension, severe Anemia, Thalassemia, bleeding disorders, Cancerous conditions, HIV, HBsAg.
2.Conditions with infections, Cellulitis, Diabetic ulcers, Phlebitis, Liver diseases, Convulsive disorders, Paralysis, unconscious individual, pregnant woman.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Ruja (pain)
Rukshata (dryness)
Daha (burning sensation)
Kandu (itching)
 		 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
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/ Phase 3 
Date of First Enrollment (India)   15/03/2025 
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="3"
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   This is a single blind randomized comparative clinical study to evaluate the effect of kanakadi lepa with out without siravyadha in 15 days. This study comprise of two groups of 30 subjects with ruja ( pain), rukshata (dryness), daha ( burning sensation), kandu (itching) associated with  padadari. Study will be conducted in ALN Rao memorial ayurvedic hospitals in koppa , koppa taluk, chikmagaluru district 577126, karnataka, india. Primary out come measure will be ruja ( pain), rukshata (dryness), daha ( burning sensation), kandu (itching) in 15 days. 
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