| CTRI Number |
CTRI/2025/03/083623 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To find out the efficacy of aragwadha kshar pichu kshar application in the management of dushta vrana |
|
Scientific Title of Study
|
RANDOMISED CONTROLLED OPEN CLINICAL STUDY TO EVALUATE THE EFFICACY OF ARAGWADHA KSHAR PICHU APPLICATION IN THE 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 Sagar Suresh Jadhav |
| Designation |
PG SCHOLAR |
| Affiliation |
Siddhakala Ayurved Mahavidyalaya Sangamner |
| Address |
Shalyatantra OPD number-6 Siddhakala Ayurved Mahavidyalaya sangamner ,Pimparne road,Sangamner khurd Sangamner
Shalyatantra OPD number-6 Siddhakala Ayurved Mahavidyalaya sangamner ,Pimparne road,Sangamner khurd Sangamner
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
8329339358 |
| Fax |
|
| Email |
sagarjadhav307@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naimish Saraf |
| Designation |
Head of Department Shalyatantra |
| Affiliation |
Siddhakala Ayurved Mahavidyalaya Sangamner |
| Address |
Shalyatantra OPD number-6 Siddhakala Ayurved Mahavidyalaya sangamner ,Pimparne road,Sangamner khurd Sangamner
Shalyatantra OPD number-6 Siddhakala Ayurved Mahavidyalaya sangamner ,Pimparne road,Sangamner khurd Sangamner
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9766786123 |
| Fax |
|
| Email |
naimishsaraf@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naimish Saraf |
| Designation |
Head of Department of shalya tantra |
| Affiliation |
Siddhakala Ayurved Mahavidyalaya Sangamner |
| Address |
Siddhakala ayurved mahavidyalaya,Sangamner pimparne road,sangamner khurd,sangamner
Siddhakala ayurved Mahavidyalaya Sangamner,Pimparne road,Sangamner khurd
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9766786123 |
| Fax |
|
| Email |
naimishsaraf@gmail.com |
|
|
Source of Monetary or Material Support
|
| Siddhakala ayurved mahavidyalaya and research centre pimparne Road,Sangamner khurd Ahamadnagar MAHARASHTRA 422605 |
|
|
Primary Sponsor
|
| Name |
Dr Sagar jadhav |
| Address |
Siddhakala Ayurved Mahavidyalaya ,Sangamner ,Sangamner khurd,Pimparne Road, 422605,Tal Sangamner Dist Ahmednagar,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 |
| Dr Sagar Jadhav |
Siddhakala Ayurved Mahavidyalaya |
Shalya Tantra OPD Number 6 Siddhakala Ayurved Mahavidyalaya ,Pimparne Road ,Sangamner ,Ahmadnagar,MAHARASHTRA
Ahmadnagar
MAHARASHTRA |
8329339358
sagarjadhav307@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee Siddhakala ayurved mahavidyalaya sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L988||Other specified disorders 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: Aragwadha Kshar pichu , Reference: Sushrut Sutra Sthan 11/12, Route: Topical, Dosage Form: Kshara , Dose: 1(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 12 Days, anupAna/sahapAna: No, Additional Information: Aragwadha kshar pichu with tab Zifi 200 mg BD | | 2 | Comparator Arm (Non Ayurveda) | | - | EUSOL | NS and EUSOL wash with Tab Zifi 200 mg BD |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient having sign and symptoms of dushta vran(infected wound) and its size within lengh upto 5cm ,depth upto 0.5 cm. |
|
| ExclusionCriteria |
| Details |
Patient suffering from major illness like cirrhosis, Ascites, Renal
failure DM, TB,
Leprosy, pregnancy, Jaundice, Varicosity, HIV
Patient with malignancy.
Bleeding disorder (increased BT and CT)
TAO
Diabetic wounds
Multiple wounds |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Aragwadha kshar pichu in the management of dushta vrana with special reference to infected wound |
12 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Study the Effect of Aragwadha Kshar Pichu On vedana,strav,kandu,vrana gandha and slough in dushta vrana
2)Study the propeties of Aragwadha kshar pichu like shodhan |
12 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 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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
|
Infected wound mostly requires surgical debridement to stabilize the
patient as well as to promote healing processes. But surgical debridement means
longer hospitalization, wound care and economical expenses which affect person
physically as well as mentally. But application of Aragwadha kshar pichu is para surgical process which Dont need Hospitalization.Also it is More Effective ,Multipurpose,Economically Affordable and Easy to use,In Sushruta sanhita ,Dravyas in Aragwadhadi Gana are Explained For Shodhan of Dushta vrana, which basically reduces kleda i.e slough and there by promotes Healthy Granulation Tissue and leads to wound healing. |