| CTRI Number |
CTRI/2025/02/081169 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Study The Effect Of Tankanamla Malahara in Infected Wound |
|
Scientific Title of Study
|
Randomised Controlled Clinical Trial To Evaluate The Efficacy Of Tankanamla Malahara in Management Of Dushta Vrana With Special Reference To Infected Wound |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Priyanka Sunil Shendage |
| Designation |
PG Scholar MS Shalya Tantra |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya,Gadhinglaj |
| Address |
Shalyatantra Department,
OPD No. 3,
Late Kedari Redekar Ayurvedic Mahavidyalaya And PG Research Centre Gadhinglaj, P2 MIDC Area, Shendri Mal, Gadhinglaj,Dist-Kolhapur,
Pincode - 416502,
State - Maharashtra,
Country - India
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
8408855723 |
| Fax |
|
| Email |
priyankashendage9991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Vijay Shivrudrappa Rudrapgol |
| Designation |
MS Shalya Tantra,HOD Shalya Tantra Department |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya,Gadhinglaj |
| Address |
Shalyatantra Department,
OPD No. 3,
Late Kedari Redekar Ayurvedic Mahavidyalaya And PG Research Centre Gadhinglaj, P2 MIDC Area, Shendri Mal, Gadhinglaj,Dist-Kolhapur,
Pincode - 416502,
State - Maharashtra,
Country - India
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9226150809 |
| Fax |
|
| Email |
drvijayrudrappa@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Priyanka Sunil Shendage |
| Designation |
PG Scholar MS Shalya Tantra |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya,Gadhinglaj |
| Address |
Shalyatantra Department,
OPD No. 3,
Late Kedari Redekar Ayurvedic Mahavidyalaya And PG Research Centre Gadhinglaj, P2 MIDC Area, Shendri Mal, Gadhinglaj,Dist-Kolhapur,
Pincode - 416502,
State - Maharashtra,
Country - India
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
8408855723 |
| Fax |
|
| Email |
priyankashendage9991@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shalyatantra Department,
OPD No. 3,
Late Kedari Redekar Ayurvedic Mahavidyalaya And PG Research Centre Gadhinglaj, P2 MIDC Area, Shendri Mal, Gadhinglaj,Dist-Kolhapur,
Pincode - 416502,
State - Maharashtra,
Country - India |
|
|
Primary Sponsor
|
| Name |
Vd Priyanka Sunil Shendage |
| Address |
Shalyatantra Department,
OPD No. 3,
Late Kedari Redekar Ayurvedic Mahavidyalaya And PG Research Centre Gadhinglaj, P2 MIDC Area, Shendri Mal, Gadhinglaj,Dist-Kolhapur, Pincode - 416502,
State - Maharashtra,
Country - 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 |
| Vd Priyanka Sunil Shendage |
Late Kedari Redekar Ayurvedic Mahavidyalaya And Hospital, Gadhinglaj |
Shalyatantra Department,
OPD No. 3,
Late Kedari Redekar Ayurvedic Mahavidyalaya And PG Research Centre Gadhinglaj, P2 MIDC Area, Shendri Mal, Gadhinglaj,Dist-Kolhapur, Pincode - 416502,
State - Maharashtra,
Country - India
Kolhapur
MAHARASHTRA |
08408855723
priyankashendage9991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Late Kedari Redekar Ayurvedic Mahavidyalaya And Research Centre, Gadhinglaj |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tankanamla Malahara, Reference: Rasa Tarangini , Ksaratrika Vijnaniya Taranga, 13/112,113, Route: Topical, Dosage Form: , Dose: 5(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 21 Days, Reference: No, Route: -, Dosage Form: , Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Betadine Ointment | Betadine Ointment will be applied once daily on infected wound for 21 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Randomised selection of patients irrespective of age, sex, economical status etc,
Patient having signs and symptoms of Dushta vrana.
Dushta vrana having surface area less than 50cm²[10cm(l)×5cm(b)] and maximum depth 5mm will be randomly selected. |
|
| ExclusionCriteria |
| Details |
Known case of HIV, HBsAG, Uncontrolled diabetes etc. Patient suffering from wounds like Tubercular Ulcers, Venous Ulcers, Leprotic Ulcers, Malignant Ulcers, Burns etc. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Disinfection of infected wound |
21 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Disinfection also help in wound healing |
21 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/03/2025 |
| 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 - NO
|
|
Brief Summary
|
This study is a randomised controlled clinical trial to evaluate the efficacy of tankanamla malahara in management of infected wound with special reference to infected wound. Comparative group is betadine ointment and trial group is tankanamla malahara. Data will be collected with the help of history taking and examination of patients. |