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CTRI Number  CTRI/2022/09/045716 [Registered on: 20/09/2022] Trial Registered Prospectively
Last Modified On: 22/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Management of Diabetic Foot Ulcers using comprehensive ayurvedic treatment protocol. 
Scientific Title of Study   “CLINICAL STUDY TO EVALUATE THE EFFICACY OF A COMPREHENSIVE TREATMENT PROTOCOL IN THE MANAGEMENT OF MADHUMEHAJANYA DUṢṬA VRAṆA VIS-À-VIS DIABETIC FOOT ULCER” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrNarayan KR 
Designation  Assistant Professor 
Affiliation  Ayurveda Mahavidyalaya 
Address  #484-Devadeyam, 19th main Judicial layout GKVK post Bengaluru
Heggeri Colony, Old Hubli, Hubli, Karnataka 580030
Dharwad
KARNATAKA
560065
India 
Phone  8951218198  
Fax    
Email  danu.nani@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrNarayan KR 
Designation  Assistant Professor 
Affiliation  Ayurveda Mahavidyalaya 
Address  #484-Devadeyam, 19th main Judicial layout GKVK post Bengaluru
Heggeri Colony, Old Hubli, Hubli, Karnataka 580030
Dharwad
KARNATAKA
560065
India 
Phone  8951218198  
Fax    
Email  danu.nani@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrSiddanagouda A Patil 
Designation  Associate Professor 
Affiliation  Ayurveda Mahavidyalaya 
Address  Ayurveda Mahavidyalaya College and Hospital Heggeri Colony, Old Hubli, Hubli, Karnataka 580030
Heggeri Colony, Old Hubli, Hubli, Karnataka 580030
Dharwad
KARNATAKA
580030
India 
Phone  9448565198  
Fax    
Email  drsapatilms@gmail.com  
 
Source of Monetary or Material Support  
Ayurveda Mahavidyalaya College and Hospital Heggeri Extn, Hubballi-580024 Office Ph:08362305422 Fax:0836-2305122 
 
Primary Sponsor  
Name  Ayurveda Mahavidyalaya College and Hospital 
Address  Heggeri Extn, Hubballi-580024 Office Ph:08362305422 Fax:0836-2305122 
Type of Sponsor  Government medical college 
 
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 
DrNarayan KR  Ayurveda Mahavidyalaya, Hubballi  Ayurveda Mahavidyalaya, Hubballi Department of Shalya Tantra OPD No: 04 Heggeri Extn, Hubballi-580024 Office Ph:08362305422
Dharwad
KARNATAKA 		 8951218198
0836-2305122
danu.nani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ayurveda Mahavidyalaya, Hubballi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E116||Type 2 diabetes mellitus with other specified complications. Ayurveda Condition: DUSHTAVRANAH, (2) ICD-10 Condition:E106||Type 1 diabetes mellitus with other specified complications. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DÄ«pana-Pācana, Sadhyo Virecana, PariÅ›eka and Taila Picu prayoga  1. DÄ«pana-Pācana for first 3 days with GuducÄ« cÅ«rṇa 5 gm BD with warm water, Before food. 2. Sadhyo Virecan on the 4th day with Trivrit lehya. 3.PariÅ›eka with Triphala Qwatha From 5th day onwards till 30th day or till the complete healing of the wound. (whichever is earlier) 4.Taila Picu prayoga with ViparÄ«tamalla taila From 5th day onwards till 30th day or till the complete healing of the wound. (whichever is earlier) 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Subjects who are Madhumehi (Diabetic) with the clinical features of Duṣṭa vraṇa (Diabetic
foot ulcer) with Type I or Type II Diabetes Mellitus will be included.
2. Subjects will be selected irrespective of age and gender.
3. Subjects with or without Hypertension will also be included. 
 
ExclusionCriteria 
Details  1. Subjects with Madhumehajanya Duṣṭa vraṇa with associated features of gangrene will be
excluded.
2. Subjects with Madhumehajanya Duṣṭa vraṇa involving bone will be excluded.
3. Subjects with other systemic diseases like HIV, HBsAg, any Malignancy, DVT, Tuberculosis
etc will be excluded.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of the proposed comprehensive treatment protocol in the management of Madhumehajanya Dushta Vrana  Outcomes will be assessed:
1. Before starting the intervention
2. After 3rd day (After Deepana and Pachana)
3. After 4th day (After Sadhyo Virechana)
4. Here onwards Every 5 days once for 1 month(study period) or till complete healing of the wound (whichever is earlier)

Follow up is done once a week for 1 month after completion of the treatment duration or complete healing of the wound (whichever is earlier) 
 
Secondary Outcome  
Outcome  TimePoints 
To formulate a comprehensive treatment protocol for the management of
Madhumehajanya duṣṭa vraṇa vis-à-vis Diabetic foot ulcer.
 		 5 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/11/2022 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [danu.nani@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 25-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary
Modification(s)  		 Diabetes Mellitus has now become a global pandemic due to erratic food habits of the people and also due to the present day sedentary lifestyle. India has an estimated 77 million people with diabetes, which makes it the second most affected country in the world, after China. As per the WHO, Diabetes is a major cause of blindness, kidney failure, heart attacks, stroke and foot ulceration leading to lower limb amputation. Wound/ulcer is the breach in the continuity of the skin which results in localized cellular and molecular changes. Non healing ulcer or dushta vrana is the one which has combination of signs and symptoms which are otherwise not seen in a healthy healing wound and which results in excess foul-smelling discharge, pain, slough etc due to various internal and external factors. Diabetes mellitus is one such systemic factor which can result in an non healing ulcer and make the diabetic patient prone to develop various complications. Among all these complications related to Diabetes mellitus, foot ulceration is the most common, affecting approximately 15% of diabetic patients during their lifetime. Between 0.03% and 1.5% of patients with diabetic foot, require an amputation. It has been estimated that, globally, a lower limb (or part of a lower limb), is lost to amputation every 30 seconds as a consequence of diabetes. This is because of multiple pathologies like micro angiopathy of the foot, neuropathy, association with atherosclerosis etc and also due to various other factors like improper diabetic medication, improper diet, barefoot walking, low socio-economic conditions, minor un-noticed trauma and also lack of awareness regarding foot care which patients suffering from diabetes should follow. All these factors lead to formation of diabetic foot ulcer which makes the life of the patient miserable with its nonhealing nature, foul smell, pain, repeated superimposed infections etc and also can lead to gangrenous changes in the affected foot finally resulting in amputation of the affected leg. Limb amputation has a major impact on the individual, not only in distorting body image, but also with regard to loss of productivity, increasing dependency, and costs of treating foot ulcers if patients require inpatient care. After an amputation, prognosis is poor and quality of life is further deteriorated. In a 5-year follow-up study on patients who underwent amputation due to diabetic foot ulcers, 49% had undergone a second amputation, 68% had died and only 19% of the patients with a lower leg amputation were able to walk 1 km. It was also observed in a study that 39-68% of patients who have an amputation will die within 5 years after surgery. Hence, treating diabetic foot ulcer and avoiding amputation holds a significant role and has become a challenging task to accomplish in the management of diabetic foot ulcer. Ayurveda is an authentic medical science which has a holistic approach to maintain the health of healthy individuals and also to cure the diseased ones. It talks about diseases affecting the body and the mind which can either be caused as a result of Internal vitiation of doá¹£a or caused as a result of an external injury. Vrana is one such entity which can be resulted both due to vitiation of doá¹£a and also due to an external injury. Acharya Sushruta has elaborately explained about dushta vrana in Sushruta Samhita and has mentioned 60 specific treatment modalities for the management of a dushta vrana. While explaining the lakshanas of dushta vrana he mentions features like puti puya, puti maṃsa, puti sira, puti snayu etc which indicates a non-healing ulcer and which can be seen even in case of a diabetic ulcer caused due to uncontrolled diabetes or due to an injury in a patient having increased blood glucose levels. Also, while explaining the prognosis of dushta vrana he clears that vrana in a madhumehi i.e Madhumehajanya vrana as considered in the present study, resulted due to an external injury or due to prameha pidaka, is difficult to treat and takes longer time to heal. In this regard Madhumehajanya vrana can also be considered under dushta vrana and same line of treatment of dushta vrana can be employed even in treating madhumehajanya dushta vrana. Ayurveda has elaborate explanation on the management of Duṣṭa vraṇa which involves Shashti upakrama, whose principles when used properly can result in healing of even stubborn non healing ulcers like diabetic foot ulcers. Selection of the specific treatment among these 60 upakrama depends on the condition of the patient and also on the yukti of the Vaidya. In this study, Deepana-Pacana, Sadhyo Virecana, Parisheka and Taila Pichu prayoga are selected to formulate a comprehensive treatment protocol which can be followed to manage madhumehajanya dushta vrana with special reference to diabetic foot ulcer. The comprehensive treatment protocol planned for a period of 30 days includes three days of deepana-pacana, Sadhyo Virecana on the fourth day, followed by Parisheka and taila Pichu prayoga for 26 days or till the complete healing of the wound, whichever is earlier. Deepana-Pacana stimulates the agni and removes the ama which is the primary cause of all diseases. Madhumehajanya dushta vrana can be considered as an upadarava of madhumeha, having predominance of pitta and kapha, so Sadhyo virecana planned in this condition helps in koshta shuddhi by eliminating the doá¹£a. Later, Parisheka done before the taila pichu prayoga helps in removal of slough and sodhana of vrana. Viparitamalla taila is selected here as an interventional drug for taila pichu prayoga because of its peculiar indication that it can be used even in those patients who do not follow specific diet and regimens that are required for proper healing of the wound. Hence, in the present study a black box design comprehensive protocol will be formulated and will be evaluated in the management of dushta vrana in madhumehi or madhumehajanya dushta vrana vis-à-vis diabetic foot ulcer. 
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