| CTRI Number |
CTRI/2025/04/085176 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
20/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Lepa] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of Guduchyadi Lepa application in patients with thrombophlebitis |
|
Scientific Title of Study
|
Randomized open controlled clinical study to evaluate the efficacy of Guduchyadi Lepa in Agantuj Vranashotha with special reference to 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 Sarang Rajendra Patil |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli |
| Address |
OPD No 4 Shalyatantra department 3rd floor Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7397953896 |
| Fax |
|
| Email |
sarangpatil1616@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ardra Bhagwatrao Thorat |
| Designation |
PG Guide |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli |
| Address |
OPD No 4 Shalyatantra department 3rd floor Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9970223088 |
| Fax |
|
| Email |
drardrathorat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ardra Bhagwatrao Thorat |
| Designation |
PG Guide |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli |
| Address |
OPD No 4 Shalyatantra department 3rd floor Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9970223088 |
| Fax |
|
| Email |
drardrathorat@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPD Patients Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli Tal Panhala Dist Kolhapur State Maharashtra India Pincode 416114 |
|
|
Primary Sponsor
|
| Name |
Dr Sarang Rajendra Patil |
| Address |
OPD No 4 Shalyatantra department 3rd floor Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli Tal Panhala Dist Kolhapur Maharashtra 416114 India |
| 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 Sarang Rajendra Patil |
Yashwant Dharmarth Rugnalaya Kodoli |
OPD No 4 Shalyatantra department 3rd floor Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli Tal Panhala Dist Kolhapur Maharashtra India
Kolhapur
MAHARASHTRA |
7397953896
sarangpatil1616@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: VRANASOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sushruta Samhita Sutrasthan 37/4-5, Procedure details: Affected area clean with normal saline and allowed to dry then Guduchyadi Lepa will be applied in adequate quantity twice a day for 5 days
)
(1) Medicine Name: Guduchyadi Lepa , Reference: Sushruta Samhita Sutrasthan 37/4-5, Route: Topical, Dosage Form: Lepa Churna, Dose: 00(g), Frequency: bd, Duration: 5 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Heparin based ointment | Heparin based ointment applied on affected area in aquate quantity twice a day for 5 days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Agantuj Vranashotha with special reference to superficial thrombophlebitis
Patients have developed thrombophlebitis due to IV infusion and medication
Thrombophlebitis involving area less than 5 cm |
|
| ExclusionCriteria |
|
|
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 |
| To study the efficacy of local application of Guduchyadi Lepa in required amount twice a day for 5 days in Agantuj Vranashotha with special reference to thrombophlebitis |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the Vranashotha in detail according to Ayurveda and Thrombophlebitis according to modern text
To study the probable mode of action of Guduchyadi Lepa
To assess the improvement of signs and gradation of assessment criteria |
5 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/05/2025 |
| 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="1"
Months="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Response
- For how long will this data be available start date provided 18-03-2025 and end date provided 03-01-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Randomized open controlled clinical study to evaluate the efficacy of Guduchyadi Lepa in Agantuj Vranashotha with special reference to Thrombophlebitis Assessment of signs and symptoms will be done on follow up days and outcomes will be assessed after 5 days |