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CTRI Number  CTRI/2025/01/079270 [Registered on: 23/01/2025] Trial Registered Prospectively
Last Modified On: 20/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To Evaluate The Efficacy Of Guduchi Kwath Dhawan In The Management Of Dushtavrana W.S.R. Diabetic Wound 
Scientific Title of Study   Randomised Controlled Clinical Trial To Evaluate The Efficacy Of Guduchi Kwath Dhawan In Management Of Dushta Vrana W.S.R. To Diabetic Wound 
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 Aditya Digambarrao Kure 
Designation  P G Scholar 
Affiliation  Late Kedari Redekar Ayurvedic Mahavidyalaya  
Address  Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department Gadhinglaj Kolhapur pin 416502

Kolhapur
MAHARASHTRA
416502
India 
Phone  7821964939  
Fax    
Email  adityakure1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amitkumar Pundpal 
Designation  Professor of Shalyatantra Department  
Affiliation  Late Kedari Redekar Ayurvedic Mahavidhyalaya Gadhinglaj 
Address  Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department Gadhinglaj Kolhapur pin 416502

Kolhapur
MAHARASHTRA
416502
India 
Phone  9420779594  
Fax    
Email  dramitpundpal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amitkumar Pundpal 
Designation  Professor of Shalyatantra Department  
Affiliation  Late Kedari Redekar Ayurvedic Mahavidhyalaya Gadhinglaj 
Address  Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department Gadhinglaj Kolhapur pin 416502

Kolhapur
MAHARASHTRA
416502
India 
Phone  9420779594  
Fax    
Email  dramitpundpal@gmail.com  
 
Source of Monetary or Material Support  
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department Gadhinglaj Kolhapur pin 416502 
 
Primary Sponsor  
Name  Dr Aditya Digambarrao Kure 
Address  Late Kedari Redekar Ayurvedic Mahavidyalaya Shalya Department Gadhinglaj Kolhapur pin 416502 
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 Aditya Digambarrao Kure  Late kedari Redekar Dharmaday Rugnalaya Kolhapur  Shalyatantra Male and Female ward no 1 and 2 and 3
Kolhapur
MAHARASHTRA 		 7821964939

adityakure1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Kolhapur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L988||Other specified disorders of the skin and subcutaneous tissue. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Dhavana (Procedure Reference: Sushrut chikitsasthan 2/86-88, Procedure details: patient will be in suitable position in ward or dressing room, accordingly prepared guduchi kwatha will be poured directly over the wound with the help of small bowl under sterile conditions until the complete wound is thoroughly get wet. The wound will be mopped with gauze piece by gentle typing, then sterile double layer,gauze piece soaked, wet in guduchi kwatha will be placed over the wound, then dressing of the wound will be done with sterile bandage. )
(1) Medicine Name: Guduchi kwatha, Reference: Sushrut sutrasthan 38/6-7, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 00(ml), Frequency: od, Duration: 21 Days
2Comparator ArmProcedure-Dhavana (Procedure Reference: Sushrut chikitsasthan 2/86-88, Procedure details: patient will be in suitable position in ward or dressing room, accordingly prepared triphala kwatha will be poured directly over the wound with the help of small bowl under sterile conditions until the complete wound is thoroughly get wet. The wound will be mopped with gauze piece by gentle typing, then sterile double layer,gauze piece soaked, wet in triphala kwatha will be placed over the wound, then dressing of the wound will be done with sterile bandage. )
(1) Medicine Name: Triphala kwatha, Reference: Bhavprakash, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 00(NA), Frequency: od, Duration: 21 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient of both the success of age group from 18 years to 16 years, which will be subjects or legally authorised representative must provide written informed consent, patient with clinical features of dushtavrana, diabetic wounds with control diabetis mellitus wound, which is localised and restricted to particular area 
 
ExclusionCriteria 
Details  Patient of any sex, which is of age group below 17 and above 60 years, patient suffering from hepatitis and or HIV infections, or any other systemic infection. Also, patient having local lymphatic spread of infection, wound very near to vital organs, subjects, who require emergency operations and with bad general conditions, osmotic wound, tubercular ulcers, leprosy, malignant ulcers 
 
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 
Patients may show signs of wound healing with relief from symptoms. there may be early signs of wound healing or at least healthy granulation with control of infection and spread.  20 days 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome will be to determine whether the interventional drug is better than the controller drug  Within 20 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 2/ Phase 3 
Date of First Enrollment (India)   01/03/2025 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

There is no doubt, that art of surgery revolves around the Vrana and its essence is

uncomplicated healing. The society believes "Time is a Great Healer" but surgeons

are dissidents in this respect, because in cases like diabetic ulcers the natural

process of healing is impaired due to uncontrolled infection ,atherosclerosis and

peripheral neuritis. They need effective treatment for early and uncomplicated

healing.

Acharya Sushruta has described the dushta Vrana, shuddha Vrana, Ruhyamana

Vrana, Samyaka Rudha Vrana, on the basis of ancient pathophysiology of wound.

For dushta Vrana he has given special attention and different line of treatment.A

vast scope of research exists in the field of Ayurveda for the benefit of the science

and humanity at large. It is true that number of scientists and medicine experts

working on various preparations which may help in achieving diabetic wound

healing.

A close study of Ayurveda reveals that a number of plants were used to achieve

the goal Vrana-Ropana. Work has been done so far in this direction by various

scholars.The present work is a further step in the field of Shalya science.

In this project kwath dhawan of drug named GUDUCHI on diabetic wound is

done. Sushruta has advised Aragwadadi Gana Kashaya and Taila in management

of Dushta Vrana (Su. Chi. 2/86-88). Same things are described in Vagbhat (As. Hr.

Ut. 25/41,66) for Dushta Vruna and Prameha.

Diabetics have impaired wound healing and impaired

resistance to infection. The disease leads to changes of the walls in small

and medium arteries with impaired blood flow.

The thickening of capillary membrane will impair passage of

leucocytes to the wounded tissue. The leucocytes function is also

impaired. Diabetic neuropathy with loss of protective reflexes renders

the diabetic patient more prone to injuries.

Diabetes results in a narrowing of the small arteries, which

cancause ulcers. This narrowing cannot be resolved, but cane prevented

by careful glucose control. Diabetes also causes peripheral neuropathy

and the loss of sensation in the legs and feet. For this reason, injuries to

the feet may go unnoticed and can progress into serious wounds. In

addition, peripheral neuropathy can cause a deformity of the foot

(Charcot foot deformity) because of inappropriate stresses being placed

on the bones, resulting in micro fractures; this deformity in turn results in

bony prominences and swelling that contributes to ulceration.

Neuropathy cannot be cured, but careful glucose control

slows its progress. Diabetics must be extremely careful about foot

care,and should seek immediate medical attention for any wounds.

Control of the blood sugar levels is an important part of all wound

treatment in diabetic patients.

The present work is a further step in the field of Shalya science. In this

project only local Dhawan of dushta vrana (Daibetic wound) with guduchi

kwath (a drug of aragwadhadi gana) has been done .

Sushruta has advised Aragwadadi Gana Kashaya and Taila in management

of Dushta Vrana (Su. Chi. 2/86- 88).


Refrences-

दुष्टव्रणेषुकर्तव्यमुर्ध्वंचाधश्चशोधनम्॥विशोषणंर्थाऽऽहारःशोवणर्स्यचमोक्षणम्

।कषायंराजिृक्षादौसुरसादौचधािनम्॥

र्योरेिकषायेणर्ैलंशोधनवमष्यर्े।क्षारकल्पेनिार्ैलंक्षारद्रव्येषुसावधर्म्॥8

(सु.वच. २/८६-८८)



Same things are described in Vagbhat (As. Hr. Ut. 25/41,66) for Dushta Vrana and

Prameha.

सप्तसुक्षालनाध्धेषुसुरसारग्वधावदकौ।भ्रशंदुष्टेव्रणेयोज्यौमेहकुष्ठव्रणेषु

च।(अ.हृ.उ. २५/४१)9

एव ःप्रक्षालनालेपघृर्र्ैलरसवियाःचूणोिवर्तश्चसंयोज्याव्रणेसप्तयथायथम्॥

(अ.हृ.उ. २५/६६)10



Aragwadhadi gana :-

आरग्वधमदनगोपपोष्टाकण्टकीकुटजपाठापाटलामूिेन्द्रयिसप्तपणतवन्बककुुषष्टकदा

सीकृष्ण्ण्टकगुहुचीवचत्रकःशाई(हूँ) ष्टाकरञ्जद्वयपटोलवकरार्वर्क्तकावनसुषिीचेवर्॥

६॥11

आरग्वधावदररत्वेषगणःश्लेष्मविषापहः।मेहकुष्ठज्वरिमीकष्टरानोप्रणशोधनः॥७॥

(सु.सू. ३८/६-७)



Kashay dhawanyogya dravya:

शङ्खिन्यङ्कोठसुमनःकरिीरसुिचतलाः।शोधनावनकषायावण

िगतश्वारग्वधावदकः॥१२॥12


The ingredients used for preparation of this herbal healer are from

Aargwadhadi gana given in Sushrut samhita which have been recommended as

good wound healer in our classical texts.



 
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