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CTRI Number  CTRI/2025/07/090050 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 27/06/2025
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 study to know the effect of haridradi drug paste in external sweelings 
Scientific Title of Study   A randomized controlled clinical study to evaluate the efficacy of haridradi lepa in the managment of agantuja shopha (superficial thrombophlebitis) 
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 Shreeraksha R C 
Designation  PG scholar 
Affiliation  Shree jagadguru gavisiddeshwar ayurvedic medical college and hospital koppal 
Address  Shree jagadguru gavisiddeshwara ayurvedic medical college and hospital koppal

Koppal
KARNATAKA
583231
India 
Phone  8217602163  
Fax    
Email  raksha001.me@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrLohit kalal 
Designation  Assosciate professor 
Affiliation  Shree jagadguru gavisiddeshwara ayurvedic medical college and hospital koppal 
Address  Shree jagadguru gavisiddeshwara ayurvedic medical college and hospital koppal department of shalya tantra opd no 16

Koppal
KARNATAKA
583231
India 
Phone  7090116108  
Fax    
Email  dr.lohitkalal7108@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrLohit kalal 
Designation  Assosciate professor 
Affiliation  Shree jagadguru gavisiddeshwara ayurvedic medical college and hospital koppal 
Address  Shree jagadguru gavisiddeshwara ayurvedic medical college and hospital koppal department of shalya tantra opd no 16

Koppal
KARNATAKA
583231
India 
Phone  7090116108  
Fax    
Email  dr.lohitkalal7108@gmail.com  
 
Source of Monetary or Material Support  
Room no 16 department of shalya tantra Shree jagadguru gavisiddeshwara ayurvedic medical college and hospital koppal karnataka india 583231 
 
Primary Sponsor  
Name  Dr Shreeraksha R C 
Address  Shri Jagadguru gavisiddeshwara ayurvedic medical college and hospital koppal department of shalya tantra room no 16 
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 Shreeraksha R C  shree jagadguru gavisiddeshwara ayurvedeic medical college and hospital koppal  room number 16 department of shalya tantra shree jagadguru gavisiddeshwara ayurvedic medical college and hospital koppal
Koppal
KARNATAKA 
8217602163

raksha001.me@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shri jagadguru gavisiddeshwara ayurvedic medical college and hospital koppal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I808||Phlebitis and thrombophlebitis ofother sites. Ayurveda Condition: SOPA-UPADRAVAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-lepa, लेप (Procedure Reference: Shrivastav Shailaja, editor. Uttarakhanda, chapter 11, verse 82-83. In: Sharangadhara Samhita. Varanasi India, Chaukambha Orientalia; 2009. p-440, Procedure details: Application of haridradi lepa over agantuja shopha (superficial thrombophlebitis))
2Comparator Arm (Non Ayurveda)-Thrombophob ointmentapplication of thrombophob ointment over (superficial thrombophlebitis) caused by iv cannula
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Clinical signs and symptom of Superficial Venous Thrombophlebitis
2)Established cases of Superficial Venous Thrombosis due to IV canulization in upper limbs
 
 
ExclusionCriteria 
Details  1)HIV and HbsAg positive patients
2)Cases of Deep Vein Thrombosis
3)Subjects under immunosuppresants
4)Patients on anti-coagulants bleeding disorders (thrombocytopenia hemophilia)
5) Uncontrolled Diabetic Mellitus(greater than250mg per dl)
 
 
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 
reduction of pain tenderness swelling and local raised temperature and after application of haridradi lepa  21 days 
 
Secondary Outcome  
Outcome  TimePoints 
thrombophob ointment is more effective than haridradi lepa  21 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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/ Phase 4 
Date of First Enrollment (India)   20/07/2025 
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="10"
Days="10" 
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  

Superficial Thrombophlebitis is a common inflammatory thrombotic disorder in which a thrombus develops in a vein located near the surface of the skin, Most superficial veins that develop thrombosis also have phlebitis.1 Phlebitis is an inflammation of the vessel wall and it manifest as localized pain, redness, swelling and palpable venous cord.2The incidence rate of intravenous catheter placement in a patient admitted to hospital is about 50%3, the most common complication associated with peripheral intravenous catheter insertion is phlebitis with reported incidence ranges from 25-59%4.

Acharya Sushruta has mentioned Agantuja Shopha in Sutrasthana 17th chapter Amapakweshaniya Adhyaya5, caused by external trauma with pitta and rakta vitiation. External trauma due to IV cannula may lead to Superficial Thrombophlebitis which has symptoms as that of Inflammatory swelling, this can be correlated to Agantuja Shopha.

The existing treatment for superficial thrombophlebitis caused by intravenous (IV) catheters is application of THROMBOPHOB OINTMENT which reduces the signs of inflammation but it has its own side effects such as abnormal blue discolouration of skin, reddish discolouration of skin, burning sensation6, numbness, skin itching and Urticaria7.

In Sharangadhara Samhita Uttarakhanda 11th chapter, HARIDRADI LEPA is mentioned as Agantuka raktaja shothagna lepa8, it can be used as a ayurvedic line of management in case of Agantuja shopha as it includes the drugs which have shothaghna, raktaprasadana, vedanaharana and raktashodaka, varnya, dahaghna, property which helps to reduce the signs of inflammation such as swelling, erythema, pain, local raised temperature9. Hence an attempt is made to evaluate the efficacy of Haridradi lepa with Thrombophob ointment in Agantuja Shopha (Superficial Thrombophlebitis).

 

 
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