FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/074025 [Registered on: 19/09/2024] Trial Registered Prospectively
Last Modified On: 11/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [local application]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical trial to see the effect of Yava kalka (Yava paste with Ghee) lepa in Dushta vrana(Non-healing wound). 
Scientific Title of Study   Randomized controlled clinical trial to evaluate the efficacy of Yava kalka lepa in Dushta vrana(Non-healing 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 Shah Nausheen Firdose Hafiz Abdul Azeem 
Designation  PG student Department of Shalya Tantra 
Affiliation  M.U.H.S Nashik. 
Address  OPD no 16 Department Shalya tantra CSMSS Ayurveda Mahavidayalya ,Kanchanwadi, Chhatrapati Sambhaji Nagar Aurangabad.

Aurangabad
MAHARASHTRA
431011
India 
Phone  9561467867  
Fax    
Email  shahnausheenfirdose@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. More S.V. 
Designation  Assosiate professor & PG Guide Department Shalya tantra 
Affiliation  M.U.H.S Nashik. 
Address  OPD no 16 Department of Shalya tantra CSMSS Ayurveda Mahavidayalya and hospital Kanchanwadi, Chhatrapati Sambhaji nagar ,Aurangabad.

Aurangabad
MAHARASHTRA
431011
India 
Phone  8983357106  
Fax    
Email  dr.swapnilmore23@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shah Nausheen Firdose Hafiz Abdul Azeem 
Designation  PG student Department Shalya tantra 
Affiliation  M.U.H.S Nashik. 
Address  OPD no 16 Department of Shalya tantra CSMSS Ayurveda Mahavidayalya Kanchanwadi Chhatrapati Sambhaji nagar Aurangabad.

Aurangabad
MAHARASHTRA
431011
India 
Phone  9561467867  
Fax    
Email  shahnausheenfirdose@gmail.com  
 
Source of Monetary or Material Support  
CSMSS Ayurveda Mahavidayalya va Rugnalya Aurangabad 431001 Maharashtra India. 
 
Primary Sponsor  
Name  Dr Shah Nausheen Firdose Hafiz Abdul Azeem 
Address  OPD no Department of Shalya tantra CSMSS Ayurved Mahavidayalya Chhatrapati Sambhajinagar, Aurangabad, 431011 Maharashtra 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 Shah Nausheen Firdose Hafiz Abdul Azeem  CSMSS Ayurveda Mahavidayalya va Rugnalaya   Opd no 16 Department Shalya tantra C.S.M.S.S Ayurved Mahavidayalya Rugnalaya Chhatrapati Sambhaji nagar.431011.
Aurangabad
MAHARASHTRA 
9561467867

shahnausheenfirdose@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CSMSS ayurveda mahavidayalya kanchanwadi chhatrapati sambhaji nagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L984||Non-pressure chronic ulcer of skin, not elsewhere classified. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-vraNasyaShaShTi-upakramAH, व्रणस्यषष्टि-उपक्रमाः kalkaH lepa (Procedure Reference: Sushruta samhita Chikitsasthan chapter 1 Dwivraniya adhyay verse 70,Vranasya shashti upkarm kalka lepa, Procedure details: After initial assessment wound will be cleaned,debries will be removed by bed side if present wound will be washed with Triphala kwath. • Yava kalka will be applied on wound . • According to Rutuchariya,Vrana Dosha pradhanta & vyakti prakruti,bandh will be applied and dressing will be done. • Application will be done on an every day as per Rutucharya. • Assessment will be done on 1st,7th,14th ,21st ,28th day of treatment))
(1) Medicine Name: Yava , Reference: Bhavprakash samhita volume purvakhand chapter dhanya varga verse 28 to 30, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 5(mg), Frequency: od, Duration: 28 Days
2Comparator ArmProcedure-vraNasyaShaShTi-upakramAH, व्रणस्यषष्टि-उपक्रमाःkalkaH lepa (Procedure Reference: Sushruta samhita chikitsasthan chapter 1 Dwivraniya adhyay verse 70, Procedure details: After initial assessment Wound will be cleaned exudate will be removed by pressing debries will be removed by bed side if present Wound will be cleaned & washed with Triphala kwath.Paste will be applied on wound According to Rutuchariya,Vrana dosha pradhanta and Vyakti prakruti,bandh will be applied and dressing will be done. Application will be done on an everyday as per and dressing will be done Assessment will be done on 1st,7th,14th ,21st ,28th day of treatment))
(1) Medicine Name: TILA, Reference: Bhavprakash samhita volume purvakhand chapterTailvarg, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 5(mg), Frequency: od, Duration: 28 Days
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Diagnosed cases of Dushta vrana.
2) Patients of age group 17to 60.
3) Vrana of size 50x50x10 mm not more then it.
4) Patients irrespective of sex, religion, socioeconomic status, profession will be selected.
 
 
ExclusionCriteria 
Details  1) Asadhya vrana .
2) Dushta vrana with no any co-morbidity along.
3) Patients having Tropical Ulcers and Ulcers due to burn and Animal bite.
4) Wound size more than 50x50x10mm.
5) Not less than 17 yr and more than 60 yrs.

• Withdrawal criteria
1) During course of study if any serious condition occurs or if any adverse event requires urgent treatment OR withdrawal criteria
2) If patient not willing to continue
3) Patients with irregular follow up

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the effect of Yava kalka on Dushta vrana Non healing wound like decrease in size,smell, discharge.   assesment will be done on base line and on 1st ,7th ,14th, 28th day of application 
 
Secondary Outcome  
Outcome  TimePoints 
To study diffrence between efficacy of Yava kalka & Tila kalka in Dushtavrana size smell & discharge with comparing rate of healing & cost .watch change in color & shape after treatment  to asses above criteria at base line & on 1st,7th,14th,28th day of local application 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   01/10/2024 
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  

·         The Aim of Ayurveda is “Swasthasya swasth rakshanam  {to promote and protect the health of healthy person} and Aturasya vikar prashaman {to treat the diseased one}.

·         Shalya is the branch of Ayurveda dealing with Grass, Wound, Stone, Dust,Iron, Soil,Bone, Hair,Nail,Pus discharge,Infected wound,Foreign body,Dead fetus removal and dealing with Yantra ,Shastra karm Kshar Agnikarm therapies and to observe and asess and treat Aam Pachyaman and Pakwa awastha of Vrana is called Shalya tantra.

·         As it is clear by Shalya tantra definition Vrana is important part of it 

·         Detailed discription of types of Vrana there explaination and treatment has been explained very briefly in dwi-vraniya adhyay of Chikitsa sthan of Sushrut samhita. 

In Dwi vraniya adhyay of Sushrut samhita treatment of wound is given by Shashti upkramas.        

·         Vrana means Spliting or tearing of body (causing discontinuity of skin and other tissues under it).as per sushruta samhita chikitsa sthan chapter 1 verse 6.it here Acharya Sushruta also explained  Shashti upakramas(i.e 60 management skills of wound ) in which Sushrut acharya explained the lepan karm also.

·         In this Shashti upkaram 29th karm is kalk application for Shodhan and Ropan of vrana 

“In case of Wound of which slough is removed which are located in muscles and do not heal ,healing paste of Sesamum mixed with Honey should be applied.”

After that ,Sushruta Acharya mentioned that some scholars says paste of barely similar to that of Sesamum .it pacifies the unripe and ripen the semi ripe ,ruptures the ripened one and cleanses and heals the ruptured Wound.

·         In other context acharya Charak also explained in 25th chapter of chikitsa sthan

The wound which are painful hard stiff and without discharge should be pasted frequently  with barely powder mixed with ghrita .

WOUND

The definition of a Wound is damage to the integrity of biological tissue, including skin, mucous membranes, and organ tissues.

Non-healing Wound

A wound that does not heal in an orderly set of stages and in a predictable amount of time 

Signs of Non-healing Wound

1.      Foul Odor 

2.      Smelling and Thick Discharge 

3.      Swelling or Redness 

4.      Fever 

5.      Hot Skin 

·      Rationale of study :

·         The Prevalence of wounds is 15.03 per 1000. The Prevalences of Acute and Chronic wounds were 10.55 and 4.48 per 1000 of the Population respectively

·         Barley production is on very large amount in India so we can make cheapest wound care product from it India ranks 22nd in Barley production worldwide.

·         We need more Ayurveda local drug applications on wound which should be Cheap,  Non- invasive, Not causing any side effect, Easily available  to all Socio-economic classes.

·         To cope up with other pathies it is need of the hour for Ayurveda to make evidence based medicine in such diseases for universal acquiescence .

·         And to prove valuable hidden treasures of Ayurveda literature Samhitas as source  of evidance based research in Samhita kaal.

·         Inadequate and inappropriate treatment of acute wounds is the commonest cause of chronic wounds.

·         The other major area of concern for wound care physicians is a limited knowledge of the physiological processes involved in wound healing.

 


 
Close