FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/100346 [Registered on: 05/01/2026] Trial Registered Prospectively
Last Modified On: 02/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectiveness of a Herbal Heel Stick in the Management of Cracked Heels 
Scientific Title of Study   A Randomized Controlled Trial on the Efficacy of “SukhamPada” – A Herbal Heel Stick in the management of Padadari (Cracked Heels) 
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 Rashika Ramesh Poojary 
Designation  PG Scholar (Swasthavritta) 
Affiliation  Padmashree Dr DY Patil Deemed To Be University, School Of Ayurveda,Nerul,Navi Mumbai-400706 
Address  Padmashree Dr DY Patil School Of Ayurveda, Deemed to be University, Sector-7, Nerul East, Navi Mumbai-400706 1st floor-Swasthyarakshan OPD NO-6 and Kayachikitsa OPD NO-1

Thane
MAHARASHTRA
400706
India 
Phone  7045393663  
Fax    
Email  ras.poo.bams24@dypatil.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Mangala D Wange 
Designation  H.O.D and Professor 
Affiliation  Padmashree Dr DY Patil Deemed To Be University, School Of Ayurveda,Nerul,Navi Mumbai-400706 
Address  Padmashree Dr DY Patil School Of Ayurveda, Deemed to be University, Sector-7, Nerul East, Navi Mumbai-400706 1st floor-Swasthyarakshan OPD NO-6

Thane
MAHARASHTRA
400706
India 
Phone  9833359698  
Fax    
Email  mangala.wange@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Dr Rashika Ramesh Poojary 
Designation  PG Scholar (Swasthavritta) 
Affiliation  Padmashree Dr DY Patil Deemed To Be University, School Of Ayurveda,Nerul,Navi Mumbai-400706 
Address  Padmashree Dr DY Patil School Of Ayurveda, Deemed to be University, Sector-7, Nerul East, Navi Mumbai-400706 1st floor-Swasthyarakshan OPD NO-6 and Kayachikitsa OPD NO-1

Thane
MAHARASHTRA
400706
India 
Phone  7045393663  
Fax    
Email  ras.poo.bams24@dypatil.edu  
 
Source of Monetary or Material Support  
Padmashree Dr DY Patil Deemed to be University, School of Ayurveda, Sector 7, Nerul east, Navi Mumbai, Maharashtra - 400706 India. 
 
Primary Sponsor  
Name  Dr Rashika Ramesh Poojary 
Address  Padmashree Dr DY Patil Deemed to be University, School Of Ayurveda, 1st floor-Swasthyarakshan OPD NO-6 and Kayachikitsa OPD NO-1 Sector-7, Nerul East, Navi Mumbai-400706, Thane, Maharashtra, India. 
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 Rashika Ramesh Poojary  DY Patil Ayurvedic Hospital OPD NO-6 and OPD NO-1  Padmashree Dr DY Patil Deemed to be University, School Of Ayurveda, Sector-7, Nerul East, Navi Mumbai Swasthyarakshan OPD NO-6 and Kayachikitsa OPD NO-1
Thane
MAHARASHTRA 		 7045393663

ras.poo.bams24@dypatil.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Padmashree Dr DY Patil Deemed to be University, School of Ayurveda  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: PADADARI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Truewise Foot Cream Roll onSubjects will be asked to Wash feet with lukewarm water, gently pat dry, and remove any dead skin before application and apply a thin layer Q.S of Truewise Foot Cream Roll on to affected foot area after cleansing before going to bed and leave it overnight for 30 days
2Intervention ArmDrugClassical(1) Medicine Name: Sukhampada, Reference: Bhavaprakash, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -Apply thin layer of Sukhampada heel stick Q.S over the cleaned and dry affected foot area before going to bed and leave it overnight.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients of both gender,aged 18-60 years.
2.Patients having with mild to moderate symptoms such as heel cracks, pain, roughness, dryness, itching.
2.Patients having more than two symptoms.
3.Participant’s willing to give written informed consent.
4.Participant’s willing to follow up. 
 
ExclusionCriteria 
Details  1.Patients not willing to participate in the study.
2.Patients with history of allergy, Infected, bleeding, or diabetic heel wounds.
3.Patients with history of any infection intervening the condition.
4.Patients having any severe systemic diseases like Renal,Cardiac Disorders. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To reduce dryness,cracks associated with pain,itching,burning sensation,distribution of cracks,number of cracks,length and average of cracks  7th day,14th day,21st day and 30th day
 
 
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 
Date of First Enrollment (India)   09/02/2026 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Title

A Randomized Controlled Trial on the Efficacy of “SukhamPada” – A Herbal Heel Stick in the Management of Padadari (Cracked Heels)

PG Scholar

Dr. Rashika Poojary

Guide

Dr. Mangala Wange (HOD & Professor)

Study site

D.Y. Patil Deemed to be University, School of Ayurveda,

Nerul, Navi Mumbai-400706.

Study Design

Double arm, Open labelled, standard control, randomized, prospective clinical study.

Study duration

30 days

Aim

To evaluate the clinical efficacy of “SukhamPada” - a classical herbal heel stick in the management of Padadari (cracked heels) in comparison with Truewise foot cream roll on.

 Objectives

1.     To evaluate the effectiveness of a classical herbal heel stick in relieving symptoms of Padadari (cracked heels).

2.     To compare the therapeutic outcome of the classical herbal stick with a standard control treatment in patients with Padadari.

  1. To assess dryness and improvement in skin texture in the affected heel area.
  2. To develop a stable, safe and effective topical formulation based on classical reference with modern application.

 

Population to be studied

Subjects of those having Padadari symptoms will be screened from Swasthavritta OPD and screening camps conducted by D Y Patil School of Ayurveda, Nerul, Navi Mumbai.

 

Sample size

GROUP A -35 participants (considering 20% dropout rate)

GROUP B -35 participants (considering 20% dropout rate)

 

Inclusion criteria

 

 

 

 

 

1.     Both male and female

2.     Aged 18 years - 60 years

3.     Patients having with mild to moderate symptoms such as heel cracks, pain, roughness, dryness, itching.

4.     Patients having more than two symptoms.

5.     Participants willing to give written informed consent.

6.     Participants willing to follow up.

Exclusion criteria

1.     Participants not willing to participate in study

2.     Patients with history of allergy, Infected, bleeding, or diabetic wounds or any infection intervening the condition.

3.     Patients having any severe systemic diseases like Renal, Hepatic,       Cardiac Disorders.

 

Efficacy parameters

  1. Photographing         
  2. Padadari signs and symptoms grade using VAS
  3. Padasputana (Number of cracks)
  4. Peeling and cracked skin with crack size (in length)
  5. Average width of cracks
  6. Quality of Life Questionnaire

Safety parameters

Adverse events recording

Efficacy & Safety parameters Assessment Schedule

  1. Photographing -V1 and V5
  2. Padadari signs and symptoms grade using VAS- V1, V2, V3, V4,V5
  3. Padasputana (Number of cracks)- V1, V2, V3, V4,V5
  4. Peeling and cracked skin with crack size (in length) -V1, V2, V3, V4,V5
  5. Average width of cracks- V1, V2, V3, V4,V5

6.     Physical examination will be done on V1, V2, V3, V4,V5

7.     Prakruti assessment scale- V1

8.     Quality of Life Questionnaire V1 and V5

9.     Questionnaire after completion of treatment-V5

Statistical Analysis

Inter-Group Comparison: Mann-Whitney U test (for non-parametric data), Unpaired t test (parametric data)

 

S.NO.

GROUPS

GROUP A

GROUP B

1.

PRODUCT

“SukhamPada” heel stick

Truewise foot cream roll on

2.

ROUTE

Topical

Topical

3.

DOSAGE

Apply a thin layer of “SukhamPada” stick over the cleaned and dry affected foot area.

 

Apply a thin layer to affected foot area after cleansing.

 

4.

TIME OF ADMINISTRATION

Evening (before going to bed and leave it overnight)

Evening (before going to bed and leave it overnight)

5.

DURATION

30 days

30 days

6.

NO. OF PARTICIPANTS

30

30

7.

VISITS/FOLLOW UP

7th day,

14th day,

21st day,

30th day,

7th day,

14th day,

21st day,

30th day,

 

 
Close