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CTRI Number  CTRI/2025/07/091897 [Registered on: 28/07/2025] Trial Registered Prospectively
Last Modified On: 28/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   AN OPEN LABEL RANDOMISED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF ACHYRANTHES ASPERA MEDICATED GAUZE WITH CALOTROPIS GIGANTEA MEDICATED GAUZE IN THE MANAGEMENT OF DIABETIC FOOT ULCER.  
Scientific Title of Study   AN OPEN LABEL RANDOMISED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF APAMARGA KSHARAPLOTA WITH SHWETA ARKA KSHARAPLOTA IN THE MANAGEMENT OF KAPHAJA DUSHTA VRANA Vis-a-vis 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  Dr SUSHMITHA M R 
Designation  2nd YEAR PG SCHOLAR 
Affiliation  JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL MYSURU 
Address  JSS AYURVEDA MEDICAL COLLEGE & HOSPITAL LALITHADRIPURA ROAD MYSURU
JSS AYURVEDA MEDICAL COLLEGE & HOSPITAL LALITHADRIPURA ROAD MYSURU
Mysore
KARNATAKA
570028
India 
Phone  9620207535  
Fax    
Email  sushmithamr06022000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Siddayya Aradhyamath 
Designation  Professor and HOD 
Affiliation  JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL MYSURU 
Address  JSS AYURVEDA MEDICAL COLLEGE & HOSPITAL LALITHADRIPURA ROAD MYSURU, 570028
JSS AYURVEDA MEDICAL COLLEGE & HOSPITAL LALITHADRIPURA ROAD MYSURU, 570028
Mysore
KARNATAKA
570028
India 
Phone  9449972788  
Fax    
Email  dr.siddesharadyamath@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Siddayya Aradhyamath 
Designation  Professor and HOD 
Affiliation  JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL MYSURU 
Address  JSS AYURVEDA MEDICAL COLLEGE & HOSPITAL LALITHADRIPURA ROAD MYSURU, 570028
JSS AYURVEDA MEDICAL COLLEGE & HOSPITAL LALITHADRIPURA ROAD MYSURU, 570028
Mysore
KARNATAKA
570028
India 
Phone  9449972788  
Fax    
Email  dr.siddesharadyamath@gmail.com  
 
Source of Monetary or Material Support  
JSS Ayurveda medical college and hospital, # 41/ E, Lalithadripura Road, Alanahalli, Mysuru- 570023  
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Sushmitha M R  JSS Ayurveda medical college and hospital  Room No.10 Department Of PG And Ph.D Studies In Shalya Tantra JSS Ayurveda Medical College and Hospital,#41/E, Lalithadripura, Mysuru- 570028 Mysore KARNATAKA 570028 India
Mysore
KARNATAKA 
9620207535

sushmithamr06022000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS AYURVEDA MEDICAL COLLEGE MYSURU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E115||Type 2 diabetes mellitus with circulatory complications. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-kShArakarma, क्षारकर्म (Procedure Reference: Susrutha samhitha, Procedure details: The gauze piece of size 23cm in diameter will be fixed to double layered circular wooden ring. On first coating Snuhi Ksheera( 50ml) will be smeared on gauze piece and kept in the UV Ksharasutra cabinet and dried. On second coating Snuhi Ksheera( 50ml) will be smeared over the gauze piece followed by Apamarga Kshara ( 20gram) application and kept in the UV Ksharasutra cabinet and dried. On third coating Snuhi Ksheera will be smeared followed by Haridra choorna ( 20gram) application and kept in the UV Ksharasutra cabinet and dried. Stored in sterile polythene bag. )
(1) Medicine Name: Apamarga kshara, Reference: Susruta samhitha, Route: Topical, Dosage Form: Kshara, Dose: 20(g), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-kShArakarma, क्षारकर्म (Procedure Reference: Susrutha samhitha, Procedure details: The gauze piece of size 23cm in diameter will be fixed to double layered circular wooden ring . On first coating Snuhi Ksheera( 50ml) will be smeared on gauze piece and kept in the UV Ksharasutra cabinet and dried. On second coating Snuhi Ksheera( 50ml) will be smeared over the gauze piece followed by Shweta Arka mrudu Kshara ( 20gram) application and kept in the UV Ksharasutra cabinet and dried. On third coating Snuhi Ksheera will be smeared followed by Haridra choorna ( 20gram) application and kept in the UV Ksharasutra cabinet and dried. Stored in sterile polythene bag. )
(1) Medicine Name: Swetha arka kshara, Reference: Susrutha samhitha, Route: Topical, Dosage Form: Kshara, Dose: 20(g), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Irrespective of Gender, religion and occupation.
• Diagnosed cases of diabetic foot ulcers within 7 cm× 8 cm size (56 cm2 area)
• Diabetic foot of grade 1 &2 as per Meggitt’s classification.
• Diabetic Foot Ulcers in controlled Diabetes Mellitus patients. (HbA1c within 7%)
• Subjects with Dorsalis Pedis Artery &Posterior Tibial Artery pulsations

 
 
ExclusionCriteria 
Details  • Patients Suffering from systemic disorders like Tuberculosis, uncontrolled HTN and HIV.
• Pregnant and lactating women.
• Wounds near major arteries and veins.
• Gangrenous ulcers, Tubercular ulcers, osteomyelitis and Ulcers with pre gangrenous changes.
 
 
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 
Subjects are assessed on the basis of subjective and objective parameters.SUBJECTIVE PARAMETERS:
• Pain
• Burning sensation
• Itching
OBJECTIVE PARAMETERS:
• Size of the wound
• Colour
• Discharge
• Odour
• Granulation tissue
 
42 days 
 
Secondary Outcome  
Outcome  TimePoints 
The intervention will be carried out until the attainment of Shuddhavrana
lakshanas.
 
1 week
 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   15/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/08/2025 
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 Yet Recruiting 
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  

NEED FOR THE STUDY:

  The word “Vrana” derived from the root word “Vran” means the splitting/tearing of the tissue and eventually leaves an imprint1. Dushta vrana which can be co-related to any non healing ulcer and it is more crucial to debride, promote epithelialization and make it possible to reach healthy granulation  tissue. If this ulcer left untreated or not properly treated, they can lead to complications.

   In present era, about 60% of diabetics will develop neuropathy, eventually leading to foot ulcer. The common causes are poor control of blood sugar level, foot deformities and improper care.

   Annual incidence of diabetic foot ulcer World wide is between 9.1-26.1 millions2. Around  15 – 25% of those will develop foot ulcer during their life time3. Overall about 5% of diabetic patients develop foot ulcer and 1% of them end up in amputation.

   Diabetic foot ulcers(DFUs) (30.5%), for example, have a comparable 5-year mortality rate to cancer (31%),which has remain unchanged since 2007 and yet funding for studies related to these life-threatening complications remains significantly lower than that for cancer research4 .

  Despite recent advances in antibiotics, topical creams, skin grafting, reconstructive surgery, and other medical treatments, it is still impossible to prevent gangrene. Managing diabetic wounds has never been an easy task for surgeons. This issue has seen as an ensuing need for amputation. Finding effective and secure interventions and medications is an ongoing search given the seriousness of the disease and lack of appropriate treatments.

  Acharya Sushsruta  mentioned Kshara  Karma as one among Shasti upakrama of vrana 5. Kshara is an alkaine substance prepared through classical methodology, having Chedana, Bhedana, Lekhana, tridoshagna6 properties also described as Anushastra and Upayantra.

  Acharya Sushruta  mentioned various types of  bandaging techniques and bandaging materials for healing purposes in different forms like Vikeshika, Kavalika, Plota and Pichu7. Among them Plota is selected for the study. Studies have found that Ksharaplota is having Shodhana , Ropana properties.

  Ksharaplota offers distruction of unhealthy tissues, draining of the debris and simultaneously enhances granulation process. Combination of Shweta Arka kshara, Snuhi ksheera and Haridra having  lekhana, shodhana and ropana properties, promotes neovascularization and  faster wound healing by its anti-inflammatory, anti-microbial and antioxidant activities.

   Here is an attempt made to evaluate the efficacy of Shweta Arka Ksharaplota and to compare its efficacy with Apamarga kshara plota in the management of  Kaphaja Dushta vrana Vis-à-vis Diabetic foot ulcer.

 

 
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