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CTRI Number  CTRI/2024/06/068888 [Registered on: 13/06/2024] Trial Registered Prospectively
Last Modified On: 08/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effect of aqueous solution of white mustard seeds as anti-septic in patients with chronic wound.  
Scientific Title of Study   A controlled clinical study on the anti microbial activity of Sarshapa arka for wound asepsis in Dushta 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 Nischintha H R 
Designation  Postgraduate Scholar 
Affiliation  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and hospital, Bengaluru 
Address  Department of PG studies in Shalya Tantra Shri Dharmasthala Manjunatheshwara institute of Ayurveda and Hospital, Anchepalya, Kumbalagodu post, Bengaluru - 560074

Bangalore
KARNATAKA
560074
India 
Phone  9449647559  
Fax    
Email  drnischinthahr@sdmayurbangalore.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Bharathi D Anvekar 
Designation  Professor  
Affiliation  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru 
Address  Department of PG studies in Shalya Tantra Shri Dharmasthala Manjunatheshwara institute of Ayurveda and Hospital, Anchepalya, Kumbalagodu post, Bengaluru - 560074

Bangalore
KARNATAKA
560074
India 
Phone  9886410690  
Fax    
Email  bharathidanvekar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nischintha H R  
Designation  Postgraduate Scholar 
Affiliation  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru 
Address  Department of PG studies in Shalya Tantra Shri Dharmasthala Manjunatheshwara institute of Ayurveda and Hospital, Anchepalya, Kumbalagodu post, Bengaluru - 560074

Bangalore
KARNATAKA
560074
India 
Phone  9449647559  
Fax    
Email  drnischinthahr@sdmayurbangalore.in  
 
Source of Monetary or Material Support  
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital,Anchepalya, Kumbalagodu post, Bengaluru- 560074 
 
Primary Sponsor  
Name  Dr Nischintha H R 
Address  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital,Anchepalya, Kumbalagodu post, Bengaluru-560074 
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 Nischintha H R  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru  Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital,Anchepalya, Kumbalagodu post, Bengaluru- 560074
Bangalore
KARNATAKA 		 9449674559

drnischinthahr@sdmayurbangalore.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalagodu post, Bengaluru  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 ArmDrugClassical(1) Medicine Name: Sarshapa arka, Reference: Sushrutha samhita; sutrasthana 5/18, Route: Topical, Dosage Form: Arka, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-Povidone iodine 5% solution Povidone iodine 5% solution, Route- topical, Dose- 10 ml, Duration-7 days
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Subjects with lakshanas of Dushta vrana .
2.Subjects with chronic non- healing wounds , features such as wounds after 7 days , putipuya , daha , paka , kandu, shopha , dushta shonita srava.
3.Subjects with wound irrespective of stage of infection.
4. Subjects irrespective of age, gender , socioeconomic status will be selected .
5. Subjects who have willingly accepted to sign the consent form.
 
 
ExclusionCriteria 
Details  1. Any topical application over Dushta vrana at the time of collection of swab.
2. Any systemic/topical antibiotic intervention for past 1 week.
3.Open wounds involving multiple body regions.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Total microbial load difference – Pre and post application of Sarshapa arka and Povidone Iodine 5% solution.  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Improvement in the quality of life
2.To assess any change in the wound by visual observation.
 		 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 2 
Date of First Enrollment (India)   26/06/2024 
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="0"
Months="0"
Days="7" 
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  
This study is a open label controlled clinical trial to study anti-microbial activity of Sarshapa arka for wound asepsis in Dushta vrana. Subjects are allocated into study an control groups respectively.
Study group includes 15 subjects qualifying the inclusion criteria of the current study with topical application of Sarshapa arka for 7 days continuously and collecting pre and post application swabs of wound on day 1 to check the difference in total microbial load and on day 7 to observe the changes in wound.
Control group includes 15 subjects qualifying the inclusion criteria for the current study with topical application of Povidone idone 5% solution for 7 days continuously and collecting pre and post application swabs on day 1 to check the difference in total microbial load and on day 7 to observe the changes in wound. 
Primary outcome measure - 1. Total microbial load difference – Pre and post application of Sarshapa arka and Povidone Iodine 5% solution.
Secondary outcome measure - 1. Improvement in the quality of life  2.To assess any change in the wound by visual observation.
Povidone iodine 5% solution is a commonly used anti-septic agent for preoperative procedures as it is considered as an ideal disinfectant. Although a vast amount of literature exists regarding its use as a topical anti-septic agent for wound asepsis in wounds, but only few works have been done regarding its reactions and long term usage. It has few disadvantages like using it for a long run has corrosive effects, local swelling, irritation, itching and rash. It has been also reported that usage of this solution didn’t increase or decrease the infection rate.
Aqueous distillate/Arka is relatively simple method of preparation and administration, with long shelf life and is safe to use topically as distillation process itself is sterile.

 
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