| CTRI Number |
CTRI/2025/04/085198 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| 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 new topical drug formulation for ulcer patient |
|
Scientific Title of Study
|
A New Topical Drug Formulation With Methanol Extract Of CASSIA AURICULATA WITH ALPHA TOCOPHEROL AND POVIDON IODINE VS REGULAR dressing solution for foot ulcer patients |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sri Siva Shyla |
| Designation |
Post graduate, general surgery student |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Room no 1, Department of general surgery ,op block , SAVEETHA medical College and hospital ,saveetha nagar thandalam, chennai,tamil nadu
Amravati guest house ,Saveetha University, thandalam
Chennai
TAMIL NADU
602105
India |
| Phone |
08940002154 |
| Fax |
|
| Email |
shyla.sri2212@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sri Siva Shyla |
| Designation |
Resident |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Room no 1, Department of general surgery ,op block , SAVEETHA medical College and hospital ,saveetha nagar thandalam, chennai,tamil nadu
Chennai
TAMIL NADU
626117
India |
| Phone |
8940002154 |
| Fax |
|
| Email |
shyla_sri @hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sri Siva Shyla |
| Designation |
Resident |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Room no 1, Department of general surgery ,op block , SAVEETHA medical College and hospital ,saveetha nagar thandalam, chennai,tamil nadu
Chennai
TAMIL NADU
626117
India |
| Phone |
08940002154 |
| Fax |
|
| Email |
shyla.sri2212@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha medical college and hospital, Saveetha Nagar,Thandalam, Chennai 602105,TamilNadu,India |
|
|
Primary Sponsor
|
| Name |
Saveetha medical college and hospital |
| Address |
Saveetha medical college and hospital, Saveetha Nagar, Thandalam Chennai 602105,TamilNadu, India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrSri Siva shyla |
Saveetha medical college and hospital |
Saveetha medical college and hospital, Saveetha Nagar,Thandalam, Chennai 602105,TamilNadu,India.
Kancheepuram
TAMIL NADU |
08940002154
shyla.sri2212@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha medical college and hospital Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S913||Open wound of foot, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
New topical drug formulation of methanol extract of Cassia auriculata with povidone iodine and alpha tocopherol |
A topical solution for foot ulcer for enhanced wound healing, to minimize wound size
Dose- 5 ml
Frequency- daily dressing
Application - topical application
Duration - 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Healthy individuals
|
|
| ExclusionCriteria |
| Details |
Pregnancy
Coronary artery disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effectiveness of new topical solution in promoting wound healing |
Day 0,day 3,day 5,day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate efficacy of methanol extract of Cassia auriculata with povidone iodine & alpha tocopherol |
Day 0,3,5,7 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 1 |
|
Date of First Enrollment (India)
|
27/04/2025 |
| 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="6" |
|
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
|
This study provides compelling evidence supporting the use of a herbal-based wound dressing as a viable alternative to conventional synthetic wound care solutions. The formulation, enriched with Cassia auriculata extract, alpha-tocopherol, and povidone-iodine, effectively addresses key challenges in wound healing, including infection control, inflammation modulation, and tissue regeneration.With further optimization to enhance its efficacy—particularly against resistant microbial strains—and rigorous clinical validation, this herbal-based intervention has the potential to revolutionize modern wound care. By integrating scientific advancements with traditional herbal medicine, this formulation offers an effective, natural, and safe alternative for wound healing, paving the way for sustainable and innovative therapeutic solutions in healthcare. |