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CTRI Number  CTRI/2023/07/055247 [Registered on: 14/07/2023] Trial Registered Prospectively
Last Modified On: 30/06/2023
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 effects of two drugs, jatyadi taila & arjuna taila in patients with varicose ulcer 
Scientific Title of Study   An open label controlled clinical trial to evaluate the effectiveness of arjuna taila in dushta vrana(varicose ulcer) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kavya A 
Designation  PG Scholar 
Affiliation  S D M Institute of Ayurveda and Hospital 
Address  Anchepalya, Kumbalagodu post, Bengaluru

Bangalore
KARNATAKA
560074
India 
Phone  9108662989  
Fax    
Email  kavyaa@sdmayurbangalore.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr KAVYA A 
Designation  PG Scholar 
Affiliation  S D M Institute of Ayurveda and Hospital 
Address  Anchepalya, Kumbalagodu post, Bengaluru

Bangalore
KARNATAKA
560074
India 
Phone  9108662989  
Fax    
Email  kavyaa@sdmayurbangalore.in  
 
Details of Contact Person
Public Query
 
Name  Dr Parvathy S 
Designation  Associate Professor 
Affiliation  S D M Institute of Ayurveda and Hospital 
Address  Anchepalya, Kumbalagodu post, Bengaluru

Bangalore
KARNATAKA
560074
India 
Phone  9746120528  
Fax    
Email  drparvathy20@gmail.com  
 
Source of Monetary or Material Support  
Self S D M Institute of Ayurveda & Hospital, Anchepalya, Kumbalagodu post, Bengaluru  
 
Primary Sponsor  
Name  Dr Kavya A 
Address  S D M Institute of Ayurveda and Hospital, Anchepalya, Kumbalagodu post, Bengaluru 
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 Kavya A  S D M Institute of Ayurveda & Hospital  Department of Shalya tantra, OPD - 21
Bangalore
KARNATAKA 
9108662989

kavyaa@sdmayurbangalore.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe Sri Dharmasthala Manjunatheswara institute of ayurveda and hospital bengaluru  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I830||Varicose veins of lower extremities with ulcer. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Arjuna taila, Reference: Sushruta sutra sthana 38th chapter 48-49 verse, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Jatyadi taila, Reference: Bhaishajya ratnavali 47th chapter 84 verse, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 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 diagnosed with varicose ulcer having the features of varicose vein& ulcer presenting with itching, pain, discharge and discolouration of surrounding tissue.
2.Subjects aged between 20-60 years irrespective of gender, religion, socio-economic status & place.
3.Ulcer size within 10cm x 10cm.
4.Chronicity of ulcer upto1year.
5.Subjects irrespective of chronicity of varicose veins.
 
 
ExclusionCriteria 
Details  1.Patients aged above 60 years.
2.Patients with Deep vein thrombosis, malignancy, arterial diseases, bleeding disorders, cellulitis, gangrene & uncontrolled diabetes mellitus (HbA1c>6.5)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
•Bates Jensen wound assessment tool
•VAS scale
•Itching
 
Assessment will be done on 0th, 7th, 14th, 21st, 30th day limited to 30 days.
 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life  Assessment will be done on 0th, 7th, 14th, 21st, 30th day limited to 30 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/ Phase 3 
Date of First Enrollment (India)   15/07/2023 
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  

Dushtavrana is a chronic type of wound resulted from varied aetiology. In contemporary science, it can be clinically correlated to chronic ulcers. Varicose ulcers are one among chronic venous ulcers. Venous ulceration is the most severe & debilitating outcome of chronic venous insufficiency in the lower limbswhich affects the quality of life of an individual by pain, itching, altered appearance, loss of sleep, functional limitations. Venous disease is responsible for around 85% of all chronic lower limb ulcers in resource-rich countries. Community based prevalence is 0.1-0.3% in adults(2-4% in elderly).The general line of treatment includes conservative approach such as Bisgaard method, compression therapy, vaccum assisted dressing, hyperbaric oxygen therapy, antibiotics, NSAIDs and surgical interventions like Thiersch grafting and laser ablation have their own shortcomings. Nearly all venous ulcers can be healed, but even in those who have successful ablation or wear their stockings religiously, there is a 20–30% incidence of re-ulceration by 5 years.

            Sushruta has explained Shashti upakrama in which specific avastha of vrana chikitsa are highlighted. It includes shodhanartha & ropanartha upakrama like kashaya, varthi, kalka, sarpi, taila, rasakriya and avachurnana. Among them taila possess kaphavatagna, vranashodhana, lekhana  properties & are indicated in sadhyovrana, dushtavrana & dagdhavrana chikitsa. Lipid soluble drugs can penetrate more rapidly than water soluble drugs at the cell surface to enter into the circulation very quickly.

            Arjuna is mentioned as one among the drugs of Nyagrodadi gana which is having kashaya rasa, ruksha guna, sheetha virya and vranya properties which could be beneficial in dushtavrana. It has antioxidant, anti-inflammatory, analgesic, antimicrobial and antiviral properties. Pre-clinical study conducted on topical application of Terminalia arjuna showed significant effect in histopathology and in wound healing.

           Considering the above facts, an attempt is made to conduct clinical study aiming at establishing the effectiveness of Arjuna taila in Dushtavrana (Varicose ulcer) chikitsa. 
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