| CTRI Number |
CTRI/2024/09/074365 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study To Evaluate The Shodhan Effect Of Gandirikadi Tailam Application In The Management Of Dushta Vrana(Infected Wound) |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial To Evaluate The Shodhan Effect Of Gandirikadi Tailam Application In The Management Of Dushta Vrana. |
| 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 Payal Gajanan Gaddamwar |
| Designation |
PG Scholar MS Shalyatantra |
| Affiliation |
Mes Ayurved Mahavidyalaya |
| Address |
Second floor,Shalyatantra department ,Pg section,Mes Ayurved Mahavidyalaya,Ghanekunt Lote,Khed,Ratnagiri
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
8329008455 |
| Fax |
|
| Email |
payal.gaddamwar001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Borse |
| Designation |
HOD & Professor MS Shalyatantra |
| Affiliation |
Mes Ayurved Mahavidyalaya |
| Address |
Second floor,Shalyatantra department ,Pg section,Mes Ayurved Mahavidyalaya,Ghanekunt Lote,Khed,Ratnagiri
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
8329008455 |
| Fax |
|
| Email |
dryogeshborase@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Payal Gajanan Gaddamwar |
| Designation |
PG Scholar MS Shalyatantra |
| Affiliation |
Mes Ayurved Mahavidyalaya |
| Address |
Second floor,Shalyatantra department ,Pg section,Mes Ayurved Mahavidyalaya,Ghanekunt Lote,Khed,Ratnagiri
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
8999203043 |
| Fax |
|
| Email |
payal.gaddamwar001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mes Ayurved Mahavidyalaya & attached Parshuram Hospital & Research center,Ghanekunt Lote ,khed,Ratnagiri,Maharashtra,india - 415722 |
|
|
Primary Sponsor
|
| Name |
Dr Payal Gajanan Gaddamwar |
| Address |
Second floor,Shalyatantra department ,Pg section,Mes Ayurved Mahavidyalaya,Ghanekunt Lote,Khed,Ratnagiri |
| 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 Payal Gajanan Gaddamwar |
Parshuram Hospital and Research center |
Shalyatantra OPD,Ghanekhunt lote khed Ratnagiri
Ratnagiri
MAHARASHTRA |
8999203043
payal.gaddamwar001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MES Ayurved Mahavidyalaya Ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Eusol with Betadine | local application over infected wound once a day for 12 days period | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gandirikadi tailam, Reference: Chakradatta 50th chapter ,160th shloka., Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 12 Days, anupAna/sahapAna: No, Additional Information: --dressing with Gandirikadi tailam will be done for 12 days in infected wound patient. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient having complaints of infected chronic wound,Pus discharge through wound ,itching,Pain,Foul smell,Slough,Redness,Swelling
2)wound size up to 10 cm
3)Diabetic patient only those who are on treatment and maintaining their BSL
3)Patient who are ready to give written consent only will be selected |
|
| ExclusionCriteria |
| Details |
1)Patient having Malignant ulcer,Tubercular ulcer,Gangrenous ulcer and Osteomylitis will be excluded
2)Patient who are not ready to give written consent
3)Uncontrolled diabetic patient
4) AIDS and HIV positive patients |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the shodhan effect of Gandirikadi tailam application in the management of Dushtavrana .
(Primary outcome will be assessed on the basis of certain objective and subjective parameters such as pain discharge tenderness floor and granulation tissue, malodour, size of wound results will be drawn with scoring system) |
12 days study
with baseline screening on 0th day.
Follow-up on 4th,8th,12th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To study etiopathogenesis of Dushta vrana .
2)To study the literature of Gandirikadi tailam.
data related all the drugs involved will be collected from different books & available ayurvedic literature to understand the action of drug & the disease etiopathogenesis |
12 days study with
Follow-up- on 4th,8th,12th day
(overall study duration 18 month) |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/10/2024 |
| 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
|
Title :- Randomized controlled clinical trial to evaluate the Shodhan effect of Gandirikadi tailam application in the management of Dushtavrana (infected wound).
Null Hypothesis :- Gandirikadi tailam application is not significantly effective in the management of Dushtavrana (infected wound).
Alternative hypothesis :- Gandirikadi tailam application is significantly effective in the management of Dushtavrana (infected wound).
Study design :- Simple Randomized Controlled Clinical Trial.
Inclusive criteria :-
1) Age - Patient age between 18 to 70 years old.
2) Patient having complaints of infected chronic wound , Pus discharge through wound ,Itching , Pain ,Foul smell , slough ,Redness, Swelling.
3) Wound size up to 10 cm.
4) Diabetic patients only those who are on treatment and maintaining their BSL.
5) Patients who are ready to give written consent only will be selected.
Exclusive criteria :-
1) Patient having Malignant ulcer, Tubercular ulcer ,Gangrenous ulcer and Osteomylitis will be excluded.
2) Patient who are not ready to give written consent .
3) Uncontrolled Diabetic patient.
4) AIDS and HIV positive patients.
Sample size :- Total 40 (20 for each group)
Patients coming in OPD and IPD of Shalyatantra department of our hospital with complaints of Dushtavrana (infected wound). Simple Randomized Sampling (Lottery Method ).
Group A:- Gandirikadi Tailam
Group B :- Eusol with Betadine
Total duration of Drug administration is 12 days ( daily dressing with gauze soaked in Gandirikadi tailam in Group A and Eusol with betadine in Group B will be done for 12 days or till appearance of healthy wound). the mode of drug administration is local application.
Follow up :- Baseline screening will be done on 0th day and follow up will be done on 4th 8th and 12th day.
Result :- Result will be drawn as per assessment criteria and statistical analysis.
|