| CTRI Number |
CTRI/2025/03/081621 [Registered on: 04/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical trial to compare the shodhan effect of VIDANG churna and HARIDRA Churna dusting on dushta vrana i.e. infected wounds. |
|
Scientific Title of Study
|
Comparative clinical trial to
evaluate the efficacy of vidang choorna avachoornan and haridra choorna avachoornan in shodhan of dushta vrana with special reference to infected wounds. |
| 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 Pravin Digambar Hawale |
| Designation |
P.G. Scholar Shalyatantra |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya, Gadhinglaj |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya, Gadhinglaj
P-2, MIDC area, Shendri Mal, A/p-Tal-Gadhinglaj Dist : Kolhapur 416502.
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
8975397471 |
| Fax |
|
| Email |
pravinhawale0007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay S Rudrappagol |
| Designation |
Head Of Department ( Shalyatantra Department) |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya, Gadhinglaj |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya, Gadhinglaj
P-2, MIDC area, Shendri Mal, A/p-Tal-Gadhinglaj Dist : Kolhapur 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9226150809 |
| Fax |
|
| Email |
drvijayrudrappa@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay S Rudrappagol |
| Designation |
Head Of Department ( Shalyatantra Department) |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya, Gadhinglaj |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya, Gadhinglaj
P-2, MIDC area, Shendri Mal, A/p-Tal-Gadhinglaj Dist : Kolhapur 416502
MAHARASHTRA
416502
India |
| Phone |
9226150809 |
| Fax |
|
| Email |
drvijayrudrappa@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Daily OPD and IPD patients at Late Kedari Redeker Ayurvedic Mahavidyalay Gadhinglaj ,P-2, MIDC area, Shendri Mal, A/p-Tal-Gadhinglaj Dist : Kolhapur 416 502 |
|
|
Primary Sponsor
|
| Name |
Dr Pravin Digambar Hawale |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya, Gadhinglaj
P-2, MIDC area, Shendri Mal, A/p-Tal-Gadhinglaj Dist : Kolhapur 416 502
P-2, MIDC area, Shendri Mal, A/p-Tal-Gadhinglaj Dist : Kolhapur 416502 |
| 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 Pravin Digambar Hawale |
Late Kedari Redekar Ayurvedic Mahavidyalaya and Dharmaday Hospital, Gadhinglaj |
Late Kedari Redekar Ayurvedic Mahavidyalaya, Gadhinglaj
P-2, MIDC area, Shendri Mal, A/p-Tal-Gadhinglaj Dist : Kolhapur 416502
Kolhapur
MAHARASHTRA |
8975397471
pravinhawale0007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Late Kedari Redeker Ayurvedic Mahavidyalay, Gadhinglaj , kolhapur |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haridra , Reference: Sushrut Samhita Sutrasthan 36, Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vidang , Reference: Sushrut Samhita , Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patient having sign and symptoms of Dushta Vrana having area less then length 5x 5 cm & max depth 5 mm will be randomly selected.
Patients having wound with the known case of Diabetes, where diabetes is in control or fair control |
|
| ExclusionCriteria |
| Details |
Known cases of HIV, Hepatitis B, any systemic disease except 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 |
| H0= There is no significant difference in the efficacy of Vidang Choorna avachoornan and Haridra choorna avachoornan in shodhan of DushtaVrana |
Assessment on0, 3,6,9,12 and 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| H1- Vidang choorna avachoornan is more effective than Haridra choorna avachoornan in shodhan of Dushta-Vrana. H2-Haridra choorna avachoornan is more effective than Vidang choorna avachoornan in shodhan of Dushta-Vrana. |
Assessment on0, 3, 6, 9, 12,15th day |
|
|
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)
|
20/03/2025 |
| 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="0"
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 is a randomised clinical trial to compare the shodhan effect of vidang and haridra choorna on Dushta vrana.
This study will be conducted at Late Kedari Redeker Ayurvedic Mahavidyalay , Gadhinglaj, kolhapur on OPD and IPD patients satisfying the criteria. Assessment will be done on days 0,3,6,9,12,15and appropriate conclusions will be drawn. |