| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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))
| | 2 | Comparator Arm (Non Ayurveda) | | - | Thrombophob ointment | application 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). |