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CTRI Number  CTRI/2026/02/104439 [Registered on: 20/02/2026] Trial Registered Prospectively
Last Modified On: 18/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical study to compare Dhatura leaf ointment with Mupirocin ointment in the treatment of chronic venous ulcers. 
Scientific Title of Study   A randomized controlled clinical trial to evaluate the effect of Dhatura patra ointment compared with Mupirocin ointment in the management of Dushta vrana (Venous ulcer) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vinukonda Sireesha  
Designation  PG Scholar 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  PG Department of Shalya tantra, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  8608032580  
Fax    
Email  sireeshavinukonda1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vasudeva Reddy 
Designation  Professor 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital,  
Address  PG Department of Shalya tantra, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  7200789978  
Fax    
Email  vdreddydr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vinukonda Sireesha 
Designation  PG Scholar 
Affiliation  Sri Jayendra Saraswathi Ayurveda College and Hospital 
Address  PG Department of Shalya tantra, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai

Thiruvallur
TAMIL NADU
600123
India 
Phone  8608032580  
Fax    
Email  sireeshavinukonda1997@gmail.com  
 
Source of Monetary or Material Support  
Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai 600123 
 
Primary Sponsor  
Name  Vinukonda Sireesha 
Address  Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai 
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 
Vinukonda Sireesha  Sri Jayendra Saraswathi Ayurveda College and Hospital  PG Department of Shalya tantra, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai 600123
Thiruvallur
TAMIL NADU 		 08608032580

sireeshavinukonda1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sri Jayendra Saraswathi Ayurveda College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I832||Varicose veins of lower extremities with both ulcer and inflammation. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-pralepa, प्रलेप (Procedure Reference: Chakradutta, Vrashopha Chikitsa 44/40, Procedure details: In Group DO, the procedure was explained to the patient and written informed consent was obtained. After arranging the required materials, the wound was cleaned with normal saline under aseptic precautions. Dhatura Patra ointment was applied evenly to cover the wound bed, followed by placement of a sterile dressing pad and proper bandaging. Observations were recorded before and after treatment.)
(1) Medicine Name: Dhattura Patra, Reference: Chakradutta, Vrashopha Chikitsa 44/40, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 0(NA), Frequency: od, Duration: 6 Weeks
2Comparator Arm (Non Ayurveda)-MupirocinIn Group MO, after explaining the procedure and obtaining written consent, the wound was cleaned with normal saline under aseptic precautions. Mupirocin ointment was applied evenly over the wound bed, followed by sterile dressing and bandaging. Observations were recorded before and after treatment.
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Subjects with clinical features of dushta vrana (venous ulcer)
 
 
ExclusionCriteria 
Details  subjects diagnosed with uncontrolled diabetes mellitus
subject with known case of DVT and Peripheral arterial diseases
Subjects with known case of Malignant ulcers, Tubercular ulcers, Lepromatous ulcer, Gangrenous wounds
subjects with known case of HIV, HBSAG 
 
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 assess the pain, inflammation and exudate levels during healing process  once in a week for 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the rate of wound contraction and epithelization in both treatment groups  once in a week for 6 weeks 
 
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)   01/03/2026 
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="2"
Months="0"
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   Venous ulcers are chronic, non-healing stasis ulcers resulting from chronic venous insufficiency, commonly affecting the lower limbs and imposing a significant burden on patients and healthcare systems. Their prevalence ranges from 0.12% to 1.69% per 1000 population, with higher occurrence in women. Clinically, these ulcers present with sloping edges, granulation tissue, slough, exudate, pigmentation, inflammation, pain, and induration, which closely resemble the features of Dushta Vrana described in Ayurvedic literature. As chronic wounds fail to heal spontaneously and require systematic Vrana Shodhana and Vrana Ropana, there is a growing need for effective, safe, and acceptable treatment modalities. Although modern wound management options are limited, Ayurveda offers extensive formulations and local therapies for wound healing. Dhatura Patra Lepa, described in classical texts for wound inflammation, has been modified into an ointment form to improve feasibility, standardization, and patient compliance. Hence, the present study adopts an integrated approach to evaluate the therapeutic potential of Dhatura Patra ointment in the management of venous ulcers. 
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