FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/082943 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 09/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical study to compare the effect of madhuyashti ghrita and panchavalkala ghrita in the management of acute wound 
Scientific Title of Study   A comparative clinical study on the effect of madhuyashti ghrita and panchavalkala ghrita local application in the management of sadyo vrana 
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 Santhosh Kumbar 
Designation  Post Graduate scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan 
Address  Department of Shalya Tantra, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,B M Road, Thanniruhalla, Hassan

Hassan
KARNATAKA
573201
India 
Phone  8660268710  
Fax    
Email  santhoshmk1422@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Maheshkumar E S 
Designation  Associate Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan 
Address  Department of Shalya Tantra, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,B M Road, Thanniruhalla, Hassan

Hassan
KARNATAKA
573201
India 
Phone  8073851473  
Fax    
Email  drmaheshkumar@sdmcahhassan.org  
 
Details of Contact Person
Public Query
 
Name  Dr Maheshkumar E S 
Designation  Associate Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan 
Address  Department of Shalya Tantra, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,B M Road, Thanniruhalla, Hassan

Hassan
KARNATAKA
573201
India 
Phone  8073851473  
Fax    
Email  drmaheshkumar@sdmcahhassan.org  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,B M Road, Thanniruhalla, Hassan , karnataka, pincode-573201, India, Phone no- 0812256460, E-mail- sdmcah@gmail.com  
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan 
Address  Department of Shalya tantra, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,B M Road, Thanniruhalla, Hassan , karnataka, pincode-573201, India, Phone no- 0812256460, E-mail- sdmcah@gmail.com 
Type of Sponsor  Private 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 
Dr Santhosh Kumbar  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  Department of Shalya Tantra, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,B M Road, Thanniruhalla, Hassan
Hassan
KARNATAKA 
8660268710

santhoshmk1422@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:T148||Other injury of unspecified body region. Ayurveda Condition: SADYOVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: PANCHAVALKALA GHRITA, Reference: Abhinava chintamani, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: MADHUYASHTI GHRITA, Reference: Astanga hrudaya , Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having any one of classical features of Ghrushta vrana, Chinna vrana, Kshata vrana
wound size less than 36 sq cm as per bates & Jansen assessment criteria
 
 
ExclusionCriteria 
Details  1. Bhinna vrana ,Viddha vrana,Picchit vrana
2. Patients suffering from leprosy, syphilis, Tubercular malignant wound, osteomyelitis, varicose veins
3. Dushta Vrana.
4. Traumatic wounds with severe complications like fracture, dislocation, severe hemorrhage.
5. Patients with other systemic illness like uncontrolled diabetes mellitus (HbA1c more than 8percentile), Human Immunodeficiency Virus and Hepatitis B positive.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment    
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Complete healing of sadyovrana within 7 days of onset  Healing of sadyovrana within 7 days 
 
Secondary Outcome  
Outcome  TimePoints 
complete healing of sadyovrana will be quick when managed with panchavalkala ghrita application compared to that of madhuyashti ghrita application  Healing of sadyovrana within 7 days of onset 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   24/03/2025 
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)  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  

AIM AND OBJECTIVES

1.     To evaluate the efficacy of Madhuyashti ghrita  local application in the management of Sadyovrana.

2.     To evaluate the efficacy of Panchavalkala Ghrita local application in the management of Sadyovrana.

3.     To compare the effectiveness of Madhuyashti ghrita with Panchavalkala Ghrita local application in the management of Sadyovrana.

INTRODUCTION

Skin injuries across the body continue to disrupt everyday life for millions of patients and result in prolonged hospital stays, infection, and death. Advances in wound healing devices have improved clinical practice but have mainly focused on treating macroscale healing versus underlying microscale pathophysiology. Consensus is lacking on optimal treatment strategies using a spectrum of wound healing products, which has motivated the design of new therapies. We summarize advances in the development of novel drug, biologic products, and biomaterial therapies for wound healing for marketed therapies and those in clinical trials. We also share perspectives for successful and accelerated translation of novel integrated therapies for wound healing

             Vrana [1,2] is the commonest painful condition that every human being suffers in their life. Ayurveda texts have given prime importance to vrana and described the vrana in thoughtful manner. Wound healing procedures described by Sushruta still hold significant place today as well. Faster the wound healing, faster is the recovery of the patient, enabling him to resume his daily routine.

Madhuyashti ghrita3 and Panchavalkala ghrita4 are very much appreciated as wound healer. Madhuyashti ghrita is known to have good healing properties while Panchavalkala ghrita has a good grahi, shodhana and ropana effect. This study is planned to see the healing property of both drugs and also to give cosmetically neat and minimal scar. These two medicines are easily available, cost effective and can be tried on OPD basis.

SOURCE OF DATA Patients diagnosed as  Sadyo Vrana will be selected from Out Patient and In Patient Departments of P.G Studies in Shalya Tantra, Sri Dharmasthala Manjunatheshwara college of Ayurveda & hospital, Hassan.

SAMPLING TECHNIQUE: Randomize sampling 

SAMPLE SIZE: 40

METHODOLOGY

Group A- Taken as Standard group

 

1.     Poorva Karma – Cleaning of the wound and surrounding with normal saline and sterile gauze.

2.     Pradhana KarmaMadhuyashti Ghrita application twice in a day for 7 days.

 

3.     Paschata Karma – bandaging will by done by using sterile pad and roller and Advise the subject to maintain the hygiene.

4.     Assessment will be done before treatment and on 7th day of treatment

5.     Follow up: On 14th day and 21st day.

 

Group B Taken as Trial group

1.     Poorva karma- Cleaning of the wound and surrounding with normal saline and sterile gauze.

 

2.     Pradhana karma –Panchavalkala ghrita application twice in a day for 7 days. 

 

3.     Paschata Karma – bandaging will by done by using sterile pad and roller and Advise the subject to maintain the hygiene.

 

4.     Assessment will be done before treatment and on 7th day of treatment.

 

5.     Follow up: On 14th day and 21st days

 

MATERIAL AND METHOD OF PREPARATION

Preparation of Madhuyashti Ghrita will be procured by Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital, Hassan pharmacy

METHOD OF PREPARATION OF PANCHAVALKALA GHRITA:

Panchavalkala kwatha 16 parts, Panchavalkala Kalka 1 part, Goghrita 4 parts. Pachavalkala kwatha is prepared primarily, followed by adding Drava Dravya to Pachavalkala churna Kalka is prepared. Later it is mixed with the Sneha and Paka is done over Agni till the fumes stops & water content is evaporated and Samyak Gritha Paaka Lakshanas are obtained thus Panchavalkala Ghrita is obtained.

DIAGNOSTIC CRITERIA:

Based on signs & symptoms of Sadyovrana.

1.           Vrana kala (time period of vrana) less than 7 days.

2.           Shoola (Pain at wound site)

3.           Daha (Burning sensation over wound site)

4.           Vrana parimana (wound size)<36 sq cm as per bates & Jansen assessment criteria

 

 

INCLUSION CRITERIA:

1.     • Patients will be select from irrespective of gender, age, religion and occupation. etc

2.     Patients having any one of classical features of Ghrushta vrana, Chinna vrana, Kshata vrana

3.     wound size <36 sq cm as per bates & Jansen assessment criteria

EXCLUSION CRITERIA:

1.     Bhinna vrana ,Viddha vrana,Picchit vrana

2.     Patients suffering from leprosy, syphilis, Tubercular malignant wound, osteomyelitis, varicose veins

3.     Dushta Vrana.

4.     Traumatic wounds with severe complications like fracture, dislocation, severe hemorrhage.

5.     Patients with other systemic illness like uncontrolled diabetes mellitus (HbA1c> 8%), Human Immunodeficiency Virus and Hepatitis B positive.

 

ASSESSMENT CRITERIA:

 

ASSESSMENT CRITERIA: (BATES & JANSEN ASSESMENT CRETERIA)

Sl no

Item

Assessment

Day 1

Day 2

Day 3

Day 4

Day 5

Day 6

Day 7

 

1.

Pain

(Vedana)

0 - No pain

1- mild pain (1-3 in NPRS)

2 - moderate (4-6 in NPRS)

3 - severe (7-10 in NPRS)

 

 

 

 

 

 

 

2

Vrana Akruthi

(Size)

1- Length x width <4 sq cm

2- Length x width 4--<16 sq cm

3- Length x width 16.1--<36 sq cm

4-Length x width 36.1--<80 sq cm

5- Length x width >80 sq cm

 

 

 

 

 

 

 

3.

Vrana oshta (Edges)

1- Indistinct, diffuse, none clearly visible

2- Distinct, outline clearly visible, attached, even with wound base

3- Well-defined, not attached to wound base

4- Well-defined, not attached to base, rolled under, thickened

5- Well-defined, fibrotic, scarred or hyperkeratotic

 

 

 

 

 

 

 

 

4.

Mamsaankura (Granulation Tissue)

1- Skin intact or partial thickness wound

2- Bright, beefy red; 75% to 100% of wound filled &/or tissue

overgrowth

3- Bright, beefy red; < 75% & > 25% of wound filled

4- Pink, &/or dull, dusky red &/or fills < 25% of wound

5- No granulation tissue present

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5.

Twacha

(skin color surrounding the wound)

1- Pink or normal for ethnic group

2 -Bright red &/or blanches to touch

3 -White or grey pallor or hypopigmented

4 -Dark red or purple &/or non-blanchable

5 -Black or hyperpigmented

 

 

 

 

 

 

 

6.

Epithelization

1 = 100% wound covered, surface intact

2 = 75% to <100% wound covered &/or epithelial tissue extends > 0.5cm into wound bed.

3 = 50% to<75% wound covered &/or epithelial tissue extends to <0.5cm  into wound bed

4 = 25% to< 50% wound covered

5 = < 25% wound covered

 

 

 

 

 

 

 

 
Close