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CTRI Number  CTRI/2024/10/074600 [Registered on: 01/10/2024] Trial Registered Prospectively
Last Modified On: 29/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical trial to evaluate effect of local application of Sharapunkha Malahar in the management of infected wound 
Scientific Title of Study   Randomized controlled clinical trial to evaluate efficacy of local application of Sharapunkha malahar 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 Raut Rohit Ashok  
Designation  PG Scholar 
Affiliation  Government Ayurved College and Hospital, Vajirabad, Nanded  
Address  Shalyatantra Department, Government Ayurved College and Hospital

Nanded
MAHARASHTRA
431601
India 
Phone  7058313661  
Fax    
Email  rohitr6163@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajendra H Amilkanthawar 
Designation  Associate Professor and Guide  
Affiliation  Government Ayurved College and Hospital, Vajirabad, Nanded  
Address  Dept. of Shalya Tantra, Government Ayurved College and Hospital, Vajirabad, Nanded

Nanded
MAHARASHTRA
431601
India 
Phone  9890569621  
Fax    
Email  drarajendrah@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajendra H Amilkanthawar 
Designation  Associate Professor and Guide  
Affiliation  Government Ayurved College and Hospital, Vajirabad, Nanded  
Address  Dept. of Shalya Tantra, Government Ayurved College and Hospital, Vajirabad, Nanded

Nanded
MAHARASHTRA
431601
India 
Phone  9890569621  
Fax    
Email  drarajendrah@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurved College and Hospital, Vajirabad, Nanded, 431601 
 
Primary Sponsor  
Name  Dr Raut Rohit Ashok  
Address  Dept of Shalyatantra Government Ayurved College and Hospital Vazirabad, Nanded,431601 
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 Rajendra H Amilkanthawar   Government Ayurved College and Hospital  Department of Shalyatantra Hospital building OPD No. 6 & 7 IPD Ward No. 51 & 63
Nanded
MAHARASHTRA 		 9890569621

drarajendrah@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Nimbadya tail, Reference: Shree Girijadayalu Shukla, Bhela Samhita, Chaukhamba Bharati Academy, 2006, Adhyaya 29, pg no. 2, Route: Topical, Dosage Form: Taila, Dose: 3(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: SHARAPUNKHA MALAHAR, Reference: Madanapal Nighantu ,Khemaraj Shrikrushnadas Prakashan Mumbai,edition 2004 abhayadi varg 1/314 page no 58, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, 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  1. Patients of Dushta vrana
2. Wound size (30mm to 150 mm)
3. Wound of duration less than
1 year.
4. Diagnosed cases infected wound 
 
ExclusionCriteria 
Details  1. Anaemic patients having HB less than 8gm%.
2. Bleeding disorder.
3. Asthmatic patients, steroid dependent / immunocompromised. 4. HIV and any systemic / organic disease.
5. Vrana situated over asthi, sandhi, kostha, marma, adhishatana.
6. Diabetic wounds and varicose ulcers
7. Patient with malignancy 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To reduce size of wound
 		 7 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.To reduce size of wound
2.To decrease Slough
3.To decrease discharge
4.To decrease swelling
5.To decrease pain
6.To decrease smell 		 7 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/10/2024 
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 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   This study is prospective, randomized, open labelled, controlled clinical study of local application of Sharapunkha malahar daily for 7days and Assessment will be done at
0th,3rd,5th, 8th day in the treatment of Dushta vrana with special reference to infected wound.
This study is conducted as PG course at single center. The primary outcome is to study efficacy of local application of Sharapunkha malahar in the treatment of Dushta vrana special reference to infected wound.
 
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