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CTRI Number  CTRI/2024/11/077484 [Registered on: 29/11/2024] Trial Registered Prospectively
Last Modified On: 28/11/2024
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   To study the efficasy of Madhuyukta Sharpunkha kalka lepa with Jaloukavcharan in dushta vrana 
Scientific Title of Study   A Randomized Controlled Clinical Study Of Madhuyukta Sharpunkha Kalka Lepa With Jaloukavacharan In The Management Of Dushta Vrana With Special Reference To Infected 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 Monica santosh Patil 
Designation  PG scholar,shalyatantra 
Affiliation  Vidarbha ayurvedic mahavidyalaya Dastur nagar Amravati 444606 
Address  Pg quarter room no 2 Vidarbha ayurvedic mahavidyalaya Dastur nagar Amravati 444606 Maharashtra India

Amravati
MAHARASHTRA
444606
India 
Phone  9021809567  
Fax    
Email  drmonnicapatil30@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manjusha Kalmegh 
Designation  HOD and associate professor, shalyatantra 
Affiliation   
Address  Shalyatantra Department OPD no 22 Vidarbha ayurvedic mahavidyalaya Dastur nagar Amravati Maharashtra India

Amravati
MAHARASHTRA
444606
India 
Phone  9518390211  
Fax    
Email  drmanjushakalmegh75@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Monica santosh Patil 
Designation  PG scholar, shalyatantra 
Affiliation   
Address  Pg quaerter room no 2 Vidarbha ayurvedic mahavidyalaya Dastur nagar Amravati Maharashtra India

Amravati
MAHARASHTRA
444606
India 
Phone  9021809567  
Fax    
Email  drmonnicapatil30@gmail.com  
 
Source of Monetary or Material Support  
OPD No.22 Shyatantra, Vidarbha ayurvedic mahavidyalaya Dastur, nagar Amravati 444606 Maharashtra India 
 
Primary Sponsor  
Name  Dr Monica santosh Patil 
Address  Vidarbha ayurvedic mahavidyalaya Dastur nagar Amravati 444606 
Type of Sponsor  Government funding agency 
 
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 Monica santosh Patil  Vidarbha ayurvedic mahavidyalaya Amravati  OPD No 22 Shalyatantra Departmentof Vidarbha ayurvedic mahavidyalaya Dastur nagar Amravati Maharashtra India 444606
Amravati
MAHARASHTRA 		 9021809567

drmonnicapatil30@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:S00-T88||Injury, poisoning and certain other consequences of external causes. Ayurveda Condition: DUSHTAVRANAH, (2) ICD-10 Condition:T07||Unspecified multiple injuries. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Madhuyukta Sharpunkha, Reference: चक्रदत्त(४४/३६), Route: Topical, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-Metrogyl-p OintmentMedicinal Name-Metrogyl-P,dosage-12g,reference-K.D.Tripathi,frequency-OD,Duration-45days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients of age 18-60 will be selected
2)Patients who will give consent for the study.
3)Both Sex
4)Patients with all types of Dushtavranawith maximum history of ≥2 weeks
5)Patients having clinical features of NijaandAgantuja Vrana i.e.foul smell ,pus discharge,pain,burning sensation and edema will be selected for study.
6)Wound size upto 8cm×8cmwill be selected. 
 
ExclusionCriteria 
Details  1.The patient who has underlying bony lesions
2. Patientswith Malignant Ulcer.
3. Tuberculous Ulcer.
4. Lepromatous Ulcer.
5. HIV, HbSAg positive patients.
6. Bleeding disorders.
7. Gangrenous wound.
8.Diabetic Wound will not be selected. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1)To compare the effectiveness of Madhuyukta Sharpunkha Lepa
(Vranaropak Lepa )and Jaloukavcharan with Metrogyl-P ointment in infected wound.
2)To propose an alternative easily available herbal preparation in the management of Dushtavrana.
3)To assess the treatment duration of Dushta Vrana( Infected wound) using study drug topically.
4)To find out therapeutic measures(Jalaukavacharan) that would be useful in the management of ulcer healing which will be cost effective . 		 45 days 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 3 
Date of First Enrollment (India)   09/12/2024 
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 Applicable 
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  
Title :-
"Randomised Controlled Clinical Study Of Madhuyukta Sharpunkha Kalka Lepa With Jalaukavcharan In The Management Of Dushta Vrana With Special Reference To Infected Wound."
AIM -
To Evaluate the efficacy of Madhuyukta Sharpunkha Kalka Lepa With Jalaukavcharan in the treatment of Dushta vrana w.s.r. to infected wound.
1) Primary
Objectives :-
To compare the effectiveness of Madhuyukta Sharpunkha Lepa(vranaropak Lepa )and Jaloukavcharan with Metrogyl-P ointment in Infected wound.
Other Objectives:-
1)To propose an alternative easily available herbal preparation in the management of Dushtavrana.
2)To assess the treatment duration of Dushta Vrana( Infected wound)using study drug topically.
3)To find out therapeutic measures(Jalaukavacharan) that would be useful in the management of ulcer healing which will be cost effectiveas well as safe (having no side effects).
3)To study the review of literature of Dushta vrana and infected wound.
Methodology :-
Study design:
Randomized control study
Study settings (Location):
70 patients fulfilling the criteria and attending the OPD/IPD of Shalyatantra department of the Hospital will be selected for the present study irrespective of age, sex, religion etc.
Duration of study:18 months
Time of application;
VranaRopakLepa(Madhyukta Sharpunkha) will be applied daily at morning session until wound heals (if not maximum upto 45 days). Jalouka will be applied with two settings in a week or as per wound condition.
INCLUSIVE CRITERIA:
1)Patients of age 18-60 will be selected
2)Patients who will give consent for the study.
3)Both Sex
4)Patients with all types of Dushtavranawith maximum history of ≥2 weeks
5)Patients having clinical features of NijaandAgantuja Vranai.e.foul smell ,pus discharge,pain,burning sensation and edema will be selected for study.
6)Wound size upto 8cm×8cmwill be selected.
EXCLUSIVE CRITERIA:
1.The patient whohas underlying bony lesions 2. Patientswith Malignant Ulcer.
3. Tuberculous Ulcer.
4. Lepromatous Ulcer.
5.HIV, HbSAg positive patients.
6. Bleeding disorders.
7. Gangrenous wound.
8.Diabetic Wound will not be selected.
Method of selection ofTrialor Control Group:-
TRIAL DRUG: Vranaropak lepa(madhuyukta sharpunkha)will be prepared according toChakradatta & Jaloukavacharan.
CONTROL DRUG:Patients subjected to Proprietary Modern Medicine.
Study Population:
70patients fulfilling the criteria and attending the OPD/IPD of Shalyatantra department of the Hospital taken for study.
Specification of Instruments and related
measurements:
A)For Madhuyukta SharpunkhaVranaropak Lepa:Khalvayantra(Mortar and pestle)
Patra(vessel),spoon-Dressing material,normal saline
B) For Jalouka: -
-Haridra(turmeric)
-water pot with water
-Dressing material
-Normal saline
SAMPLE SIZE:
Group-A(Trial Group)-35
Group-B(Control Group)-35

 
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