| CTRI Number |
CTRI/2025/03/083327 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To check the comparison of effectiveness of Application of Nirgundi Taila with Nimbapatra Taila in Management of shodhan of Dushta Vrana with special reference to infected wound |
|
Scientific Title of Study
|
Comparative Clinical Trial to Evaluate the Shodhan Effect of Nirgundi Taila and Nimbapatra Taila application 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 |
Dr Absar Husain Syed |
| Designation |
PG Scholar |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalyatantra Department Gadhinglaj Kolhapur Maharashtra Pin code 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9172008598 |
| Fax |
|
| Email |
syedabsar635@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amitkumar Bhimsing Pundpal |
| Designation |
Professor at Shalyatantra Department |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalyatantra Department Gadhinglaj Kolhapur Maharashtra
Pin code 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9420779594 |
| Fax |
|
| Email |
dramitpundpal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amitkumar Bhimsing Pundpal |
| Designation |
Professor at Shalyatantra Department |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalyatantra Department Gadhinglaj Kolhapur Maharashtra
Pin code 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9420779594 |
| Fax |
|
| Email |
dramitpundpal@gmail.com |
|
|
Source of Monetary or Material Support
|
| shalyatantra OPD no 3 patients Late Kedari Redekar Ayurvedic Mahavidyalaya p 2 midc area shendri road mal gadhinglaj maharashtra India pincode 416501 |
|
|
Primary Sponsor
|
| Name |
Dr Absar Husain Syed |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Kolhapur Maharashtra India 416501 |
| 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 Absar Husain Syed |
Late Kedari Redekar Ayurvedic Mahavidyalaya shalyatantra department OPD no 3 |
Late Kedari Redekar Ayurvedic Mahavidyalaya Shalyatantra Department OPD no.3 Gadhinglaj Kolhapur Maharashtra pin code 416501
Kolhapur
MAHARASHTRA |
09172008598
syedabsar635@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Late Kedari Redekar Ayurvedic mahavidyalaya Gadhinglaj Kolhapur |
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 | Intervention Arm | Procedure | - | talam, तलम् | (Procedure Reference: Sharangdhar Samhita Madhyam Khand 9 chap 1 to 13 shlok, Procedure details: Vrana prakshalan will be done with normal saline.Dead tissues that are easily visible can excised without much pain & wound will be made dry.Then sufficient amount of Nirgundi taila will be apply over the wound.After that a sterile dressing pad having sufficient length will be placed over the wound.Proper dressing will be done with sterile bandage cloth. This will be repeated daily for 15 days)
(1) Medicine Name: Nirgundi, Reference: Bharat Bhaishajya Ratnakar volume 3 shlok 3513, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm | Procedure | - | tailam, तैलम् | (Procedure Reference: Sharangdhar Samhita Madhyam Khand 9 chap 1 to 13 shlok [24/03, 5:51 pm] Sanjana: Sushrut Chikitsasthan 2 chap shlok 89 to 92, Procedure details: Vrana prakshalan will be done with normal saline.Dead tissues that are easily visible can excised without much pain & wound will be made dry.Then sufficient amount of Nimbapatra taila will be apply over the wound.After that a sterile dressing pad having sufficient length will be placed over the wound.Proper dressing will be done with sterile bandage cloth. This will be repeated daily for 15 days)
(1) Medicine Name: Nimbapatra taila, Reference: Sushrut Chikitsasthan 2 chap shlok 89 to 92, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patient having age between 18 to 55 years. Patients irrespective of gender, economic class, caste, religion. Patient having sign and symptoms of Dushta Vrana having area less then length 10 x 5 cm & max depth 0.5 cm will be randomly selected.Patients having wound with the known case of Diabetes where diabetes in controlled. |
|
| ExclusionCriteria |
| Details |
Known cases of HIV, Hepatitis B, any systemic disease and uncontrolled diabetes.Patients suffering from wounds like.Tubercular Ulcers Venous Ulcers Leprotic Ulcers Malignant Ulcers Burns Wounds having excessive loss of Tissues i.e. Wound include bone, and tendon injury, exposed bone. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparative Shodhan Effect of Nirgundi Taila and Nimbapatra Taila on Dushtvrana will be assessed Thorough Clinical Presentation
Wound size
Gandha Pain Discharge Kandu Daha Slough tissue |
15 Days
On 0 1st 3rd 6th 9th 12th 15th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Dushtvrana Shodhan will be assessed Through clinical examination
Pain Daha Discharge Slough tissue Wound size |
15th day of Study |
|
|
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)
|
04/04/2025 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 Comparative Clinical Trial to evaluate the Shodhan effect of Nirgundi Taila and Nimbapatra Taila application in management of Dushtavrana w.r.s to Infected wound. Study will be carried in OPD no.3 of Shalyatantra Department of Late Kedari Redekar Ayurvedic Mahavidyalaya and Hospital Gadhinglaj Kolhapur Maharashtra pincode 416502. The observation will be drawn on the basis of Symptoms and treatment given |