| CTRI Number |
CTRI/2023/06/054116 [Registered on: 19/06/2023] Trial Registered Prospectively |
| Last Modified On: |
09/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Punga thylam for madhumega viranam (Diabetic ulcer) |
|
Scientific Title of Study
|
An Open, Non-Randomized, Single arm, Single centric
Clinical trial to determine the effectiveness of Wound dressing with Punga Thailam in the management of Madhumega viranam (Diabetic Foot 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 J Lavanya |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room No.14, Department of Puramaruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai.
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
7092061802 |
| Fax |
|
| Email |
jclkasilingam1022@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M V Mahadevan |
| Designation |
Associate professor |
| Affiliation |
National Institue of Siddha |
| Address |
Room No.14, Department of Puramaruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai.
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9840417565 |
| Fax |
|
| Email |
mvmsrmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M V Mahadevan |
| Designation |
Associate professor |
| Affiliation |
National Institue of Siddha |
| Address |
Room No.14, Department of Puramaruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai.
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9840417565 |
| Fax |
|
| Email |
mvmsrmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Pandidhar Hospital, National Institute of Siddha,
Tambaram sanatorium, Chennai |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Ayothidoss Pandidhar Hospital, National Institute of Siddha, Tambaram sanatorium, Chennai -47. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 J Lavanya |
Ayothidoss Pandidhar Hospital |
Room No.14, Department of Puramaruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai.
Chennai
TAMIL NADU |
7092061802
jclkasilingam1022@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Punga thailam |
Wound Dressing with Punga thailam regularly for 48 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age: >18 years
Sex: Male, Female and Transgender
Superficial ulcer, Destruction of the thickness of the skin/ Penetrates through skin not affecting bone (Wagner’s Classification I & II)
Willing to give specimen of blood for the investigation.
Willing to take photograph.
Willing to participate in trial by signing the informed consent.
Good control of Diabetes Mellitus
|
|
| ExclusionCriteria |
| Details |
Ischemic foot
Deep Ulcer (cellulitis) / Osteomyelitis with Ulceration or abscess/ Gangrenous
patches limited to toes or part of the foot/ Gangrene of the entire foot (Wagner’s classification II, III, IV & V)
Varicose ulcer
Hansen’s disease
Tuberculous ulcer
Any active neoplastic disease
Necrotizing fasciitis
The patient who has uncontrolled diabetes will be treated for diabetes mellitus and after that he/she will be included for this study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome will be measured with the use of leg ulcer measurement tool. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2023 |
| Date of Study Completion (India) |
31/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is an open non randomized, single arm, single centric, trail to determine the therapeutic effectiveness of punga thailam in the management of madhumega viranam (diabetic foot ulcer). Patients with diabetic foot ulcers will be enrolled for the study as per inclusion and exclusion criteria. After the enrollment, treatment will be given with punga thailam. Regular wound dressing will be done, and the ulcer will be assessed weekly with the use of leg ulcer measurement tool. |