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CTRI Number  CTRI/2025/09/094330 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 08/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical Controlled Study to assess the efficacy of patoladi application in the management of dushta vrana with special reference to diabetic foot ulcer  
Scientific Title of Study   A clinical controlled study to assess the efficacy of patoladi application in the management of dushta vrana with special reference to diabetic foot ulcer 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Harshal Rajendra Patil  
Designation  Post Graduate Scholar  
Affiliation  ASHVIN RURAL AYURVED COLLEGE MANCHI HILL SANGAMNER  
Address  ASHVIN RURAL AYURVED COLLEGE AND HOSPITAL ,SADHVI PREETISUDHAJI MAHARAJ NAGAR ,MANCHI HILL ASHVI BK.TAL.SANGAMNER DIST .AHMADNAGAR MAHARASHTRA

Ahmadnagar
MAHARASHTRA
413714
India 
Phone  9527989273  
Fax    
Email  harshalpatil30598@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vd.Vishal Tamhane  
Designation  READER  
Affiliation  ASHVIN RURAL AYURVED COLLEGE MANCHI HILL SANGAMNER 
Address  ASHVIN RURAL AYURVED COLLEGE AND HOSPITAL, SADHVI PREETISUDHAJI MAHARAJ NAGAR ,MANCHI HILL,ASHVI BK,TAL.SANGAMNER DIST.AHMADNAGAR

Ahmadnagar
MAHARASHTRA
413714
India 
Phone  9764139607  
Fax    
Email  vvtamhane@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Harshal Rajendra Patil 
Designation  Post Graduate Scholar 
Affiliation  ASHVIN RURAL AYURVED COLLEGE MANCHI HILL SANGAMNER  
Address  ASHVIN RURAL AYURVED COLLEGE AND HOSPITAL SADHVI PREETISUDHAJI MAHARAJ NAGAR, MANCHI HILL, ASHVI BK TAL SANGAMNER DIST AHMADNAGAR

Ahmadnagar
MAHARASHTRA
413714
India 
Phone  9527989273  
Fax    
Email  harshalpatil30598@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Harshal Rajendra Patil  
Address  ASHVIN RURAL AYURVED COLLEGE AND HOSPITAL, SADHVI PREETISUDHAJI MAHARAJ NAGAR, TAL SANGAMNER DIST.AHMADNAGAR MAHARASHTRA 413714 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 Harshal Rajendra Patil   Ashvin rural ayurved college and hospital manchi hill   Ashvin rural ayurved college and hospital, first floor of hospital shalyatantra department room no .12 sadhvi preeti sudhaji nagar ,tal.sangamner dist.ahmadnagar maharashtra pincode- 413714 India
Ahmadnagar
MAHARASHTRA 
9527989273

harshalpatil30598@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ashvin rural ayurved college ethical 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: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Patoladi ghruta, Reference: Ashtang Sangraha, Route: Topical, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: -Ghruta application done as per wound
2Comparator ArmDrugClassical(1) Medicine Name: Jatyadi Ghruta, Reference: Ashtang Hrudya Uttartantra, Route: Topical, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: -ghruta applied as per wound
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Diagnosed cases of dushtavrana with diabetes melitus showing signs and symptoms of dushtavrana as per samhita
2.wound size 3cm to 5cm
3.patients irrespective of any social ,economic and gender group
 
 
ExclusionCriteria 
Details  Diagnosed cases o f Tuberculosis, HIV, Hepatitis B , Septicemia,
neurogenic disorders, vascular disorders.
2. Patients having tropical ulcer and ulcer due to animal bite.
3. Patients having bleeding disorders.
4. Patients of age group below 30yrs and above 60yrs.
5. K/C/O Anemia. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Compare efficacy of patoladi ghruta and jatyadi ghruta application in the management of dushta vrana with special reference to diabetic foot ulcer by using subjective and objective criteria   Total duration of medication -28 days 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NOT APPLICABLE  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   23/09/2025 
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="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   Ayurveda is an ancient science which deals with the health of
human being.
The main aim of Ayurveda is to maintain the health of well
being/healthy person and cure the diseased one. (4)
Shalyatantra is one part of ashtang Ayurveda.(2)
Acharya sushruta has given the first placed to Vrana in
shalyatantra which is mentioned in sutrasthana and chikitsasthana.

On the basis of occurrence of Vrana it is divided into two parts(4)
1.Nij vrana-Due to vitiated dosha
2.Agantuj Vrana-Due to external factors/Trauma/Burns.
In modern science, Vrana can be compared with ulcer or wound.
According to modern science,
Wound i s a discontinuity o r break i n the surface of
epithelium. (5l
As a clean wound heals naturally by the body tendency with
primary intention within minimum time period.
When the clean wound get contaminated by foreign body or
certain conditions which hampers wound healing like exposure to
radiation, immune deficiency, anemia, DM, Uremia, malignancy even due
to presence of dead tissue which may infect the wound 6l.
And if this Vrana remains untreated for longer time it can
converted into Dushta Vrana.
In Sushrut Samhita clinical features of dushta vrana are-
Atisamvrutta, Ativivrutta, Atikathin, Atimrudu, Utsana, Atisheet, Atyushna,
Krishn, Peeta, Rakt,Shukladi varnas, puyayukt
, unmargiutsangi,vivrutagandhi
Atyarthavedana, daha rag, pak, kandu, shoph,dushtashonitastravi and
deerghkalanubandhi.l?
If t h e infected wound n o t treated properly i t may causes
complications like putrefying pus discharge,severe
pain,suppuration,swelling, itching, redness which might remains for longer
period and are difficult to heal.
In Ayurveda Acharya Sushruta had explained management of
Vrana as the shashtiupakrama in chikitsasthana. 8J
It includes shodhan and ropan upkram,Shodhan which helps to
remove foreign body and slough due to which wound get pure and along
with these Ropan karma helps to heal the wound and preserve the normal
integrity of skin.
Foot ulcers are one of the main complications in diabetes
mellitus,with a 15% lifetime risk in all diabetic patients.
Sushruta mentioned the variety of upkrama to manage the
wound, snehan is one among them.
Aacharya Vagbhat mentioned ’Patoladi Ghruta’ a s in the
management of vrana in Ashtangsangraha.
The present research topic entitled as " RANDOMIZED CLINICAL
TRIAL TO ASSESS EFFICACY OF PATOLADI GRUTA IN COMPARISON WITH
JATYADI GHRUTA IN THE MANAGEMENT OF DUSHTA VRANA WITH SPECIAL
REFERENCE TO DIABETIC FOOT ULCER."
The contents o f Patoladi Ghruta have properties of
antimicrobial, analgesics ,anti-inflammatory, Immuno modulatory which
enhances wound healing.
RATIONALE OF STUDY :
To avoid surgical interventions like debridement of wound which
is invasive and painful treatment.
• Prevalence of Diabetic foot ulcer in india is 4.5%.
• The patient of Dushta vrana are increasing in the society due to
poor hygiene, malnutrition and decrease immunity.
• To assess efficacy of Patoladi ghruta in dushta vrana w.s.r diabetic foot ulcer

 
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