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CTRI Number  CTRI/2025/03/083434 [Registered on: 25/03/2025] Trial Registered Prospectively
Last Modified On: 27/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study of effect of application of Sthulapushpadi ointment and Sarjarasa ointment (malahara) with Siravedha in the management of Crack heels (Padadari) 
Scientific Title of Study   Comparative evaluation of efficacy of Sthulapushpadi ointment as against Sarjarasa ointment (malahara) with Siravedha in both groups in the management of Crack heels (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. Prastuti Pramod Dhande 
Designation  PG Scholar 
Affiliation  Mahatma Gandhi Ayurved College Hospital and Research Center, Salod (H), Wardha, Maharashtra 
Address  OPD NO 14 DEPARTMENT OF SHALYATANTRA MAHATMA GANDHI AYURVED HOSPITAL AND RESEARCH CENTER SALOD(H) WARDHA

Wardha
MAHARASHTRA
442001
India 
Phone  7774879508  
Fax    
Email  prastutidhande5@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sheetal Asutkar 
Designation  Professor & HOD 
Affiliation  MAHATMA GANDHI AYURVED HOSPITAL AND RESEARCH CENTER, SALOD(H), WARDHA 
Address  OPD NO 14 DEPARTMENT OF SHALYATANTRA MAHATMA GANDHI AYURVED HOSPITAL AND RESEARCH CENTER SALOD(H) WARDHA

Wardha
MAHARASHTRA
442001
India 
Phone  7774879508  
Fax    
Email  sheetalasutkar16@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Prastuti Pramod Dhande 
Designation  PG Scholar 
Affiliation  Mahatma Gandhi Ayurved College Hospital and Research Center, Salod (H), Wardha, Maharashtra 
Address  OPD NO 14 DEPARTMENT OF SHALYATANTRA MAHATMA GANDHI AYURVED HOSPITAL AND RESEARCH CENTER SALOD(H) WARDHA

Wardha
MAHARASHTRA
442001
India 
Phone  7774879508  
Fax    
Email  prastutidhande5@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research Center, Wardha, Maharashtra, India 442001 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education Wardha Maharashtra India 
Address  OPD 14 Department of Shalyatantra Mahatma Gandhi Ayurved Hospital and Research Center Salod (H) Wardha 442001 Maharashtra India 
Type of Sponsor  Research institution and hospital 
 
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 Prastuti Dhande  Mahatma Gandhi Ayurved College Hospital and Research Center Salod H Wardha Maharashtra  OPD 14 Department of Shalyatantra
Wardha
MAHARASHTRA 
7774879508

prastutidhande5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: PADADARI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: SARJARASA MALAHAR, Reference: RASA TARANGINI, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugOther than Classical(1) Medicine Name: STHULAPUSHPADI OINTMENT, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Weeks, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients willing with written informed consent.
Patients of either sex with age group 18 to 60 years of age.
Patients with all grades of pain, itching, dryness will be included.
Patients irrespective of sex, occupation and economic status will be included.

 
 
ExclusionCriteria 
Details  1.Known cases of Diabetes mellitus, Plantar Keratoderma, HIV positive and Athlete’s Foot.
2. Subjects suffering from skin disorders like psoriasis, Hyperkeratotic eczema.
3. Subjects having excessive discharge from cracks of the heel.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
wound healing of padadari
 
10 days 
 
Secondary Outcome  
Outcome  TimePoints 
Topical Sthulapushpadi ointment is not more efficacious then topical Sarjarasa ointment (malahara) with Siravedha in both groups in the management of Padadari.
 
36 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 3/ Phase 4 
Date of First Enrollment (India)   01/05/2025 
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="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  

Cracked heels or Padadari is important cosmetically and it affects the quality of life of a person when it starts showing its symptoms. In modern science many treatments are there for treating cracked heels like using Kleenex tissue to the affected area and then painting over it with tincture benzoin compound. Many lotions, moisturizers, healing and soothing creams are there in the market for the same. Many pre-clinical studies has advised to wear cotton socks or liquid socks for the same. In ayurvedic sciences various different modalities of treatment are mentioned for Padadari like shodhan as well as shaman chikitsa.

In Sushruta Samhita treatment consists of snehana, swedana, siravedha, and application of various lepas like ghrita, taila, vasa, majja, madhuchishti, and raal (6).

Sthulapushpa (Calendula officinalis) has known effects of skin soothing, anti-inflammatory effects, skin moisturizing effects which are importance causes for cracked heels (7). Along with sthulapushpa other contents like kumari, haridra, nimba, narikel, tuttha, manjishtha will be used in the formulation. Hence sthulapushpadi ointment will be used in the research for its healing properties in padadari.

Two fundamental tenets of Ayurvedic medicine are Shodhana and Shaman chikitsa. Shodhan chikitsa is the one where there is direct elimination of vitiated doshas. Amongst different shodhan treatments Raktamokshana is considered as best for Pitta and Rakta dushtijanya vyadhis. Siravedhan is initial line of treatment in managing shopha, vedana, ruja etc.

Siravedha can improve local microcirculation, eradicate algesic materials from the blood, and encourage the restoration of harmed tissues and hence manage padadari (8).

It is mentioned in Sushruta Sharirsthan regarding the site of Siravedha in Padadari as vein situated two angula above the Kshipra marma should be punctured.

 
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