| CTRI Number |
CTRI/2025/07/091711 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
THE Effect OF NIMBAPATRADI CHURNA DHOOP YOGA IN THE MANAGEMENT OF DUSHTA VRANA |
|
Scientific Title of Study
|
RANDOMISED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF NIMBAPATRADI CHURNA DHOOP YOGA 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 SHAILAJA DILIP NAGOLKAR |
| Designation |
M.S. SCHOLAR SHALYATANTRA SAMANYA DEPARTMENT |
| Affiliation |
LATE. KEDARI REDEKAR AYURVEDIC MAHAVIDYALAYA, GADHINGLAJ , KOLHAPUR |
| Address |
DEPARTMENT OF SHALYATANTRA SAMANYA,LATE KEDARI REDEKAR AYURVEDIC MAHAVIDYALAYA,GADHINGLAJ,KOLHAPUR
Kolhapur
MAHARASHTRA
416501
India |
| Phone |
9082255947 |
| Fax |
|
| Email |
shailajanagolkar123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRRANJEET KADAM |
| Designation |
READER |
| Affiliation |
LATE. KEDARI REDEKAR AYURVEDIC MAHAVIDYALAYA, GADHINGLAJ , KOLHAPUR |
| Address |
DEPARTMENT OF SHALYATANTRA SAMANYA,LATE KEDARI REDEKAR AYURVEDIC MAHAVIDYALAYA,GADHINGLAJ,KOLHAPUR
Kolhapur
MAHARASHTRA
416501
India |
| Phone |
9595353549 |
| Fax |
|
| Email |
drkadamrv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHAILAJA DILIP NAGOLKAR |
| Designation |
M.S. SCHOLAR SHALYATANTRA SAMANYA DEPARTMENT |
| Affiliation |
LATE. KEDARI REDEKAR AYURVEDIC MAHAVIDYALAYA, GADHINGLAJ , KOLHAPUR |
| Address |
DEPARTMENT OF SHALYATANTRA SAMANYA,LATE KEDARI REDEKAR AYURVEDIC MAHAVIDYALAYA,GADHINGLAJ,KOLHAPUR
Kolhapur
MAHARASHTRA
416501
India |
| Phone |
9082255947 |
| Fax |
|
| Email |
shailajanagolkar123@gmail.com |
|
|
Source of Monetary or Material Support
|
| LATE KEDARI REDEKAR AYURVEDIC MAHAVIDYALAYA,GADHINGLAJ,KOLHAPUR,416501 |
|
|
Primary Sponsor
|
| Name |
LATE KEDARI REDEKAR AYURVEDIC MAHAVIDYALAYA,GADHINGLAJ ,KOLHAPUR |
| Address |
P-2, MIDC AREA, SHENDRI ROAD, MAL, GADHINGLAJ, MAHARASHTRA 416501 |
| Type of Sponsor |
Private medical college |
|
|
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 SHAILAJA DILIPRAO NAGOLKAR |
LATE.KEDARI REDEKAR AYURVEDIC MAHAVIDYALAYA |
OPD NO 4 /Department surgery P-2, MIDC AREA, SHENDRI ROAD ,MAL,GADHINGLAJ, MAHARASHTRA 416501
Kolhapur
MAHARASHTRA |
9082255947
shailajanagolkar123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC 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:A00-B99||Certain infectious and parasitic diseases. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | DHOOPAN KARMA | (Procedure Reference: HARITA SAMHITA, Procedure details: VRANA DHOOPAN WILL BE DONE WITH THE HELP OF SPECIALLY DESIGNED DHOOPAN YANTRA.
FUMES ARE EXPOSED TO WOUND FOR 15 MINS FOR 10 DAYS AFTER CLEANING WOUND WITH STANDARD PROTOCOL OF DRESSING )
| | 2 | Intervention Arm | Procedure | - | DHOOPAN KARMA | (Procedure Reference: BHAISHAJYA RATNAVALI, Procedure details: VRANA DHOOPAN WILL BE DONE WITH THE HELP OF SPECIFICALLY DESIGNED DHOOPAN YANTRA .
FUMES ARE EXPOSED TO WOUND FOR 15 MINS FOR 10 DAYS AFTER CLEANING WOUND WITH STANDARD PROTOCOL OF DRESSING )
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) ALL PATIENTS WITH DUSHTA VRANA.
2) PATIENTS SELECTED IRRESPECTIVE OF SEX, OCCUPATION, EDUCATION AND HABIT. |
|
| ExclusionCriteria |
| Details |
1) SPECIFIC ULCERS LIKE LEPROMATOUS ULCER, MALIGNANT ULCER.
2) UNCONTROLLED DM
3) CHRONIC NON HEALING WOUND E.G VARICOSE VEINS |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| REDUCE THE SIGNS AND SYMPTOMS AFTER 7 DAYS |
REDUCE THE SIGNS AND SYMPTOMS AFTER 7 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| WOUND WILL HEALED OR PURIFIED IN 21 DAYS |
21 DAYS |
| NIMBAPATRADI DHOOPAN YOGA WILL BE MORE EFFECTIVE THAN NIRGUNDYADI DHOOPAN YOGA |
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)
|
06/08/2025 |
| 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="0"
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
|
OBJECTIVE :
1.PRIMARY OBJECTIVE
TO STUDT THE EFFICACY OF NIMBAPATRADI CHURNA DHOOP YOGA IN THE MANAGEMENT OF DUSHTAVRANA .
2. SECONDARY OBJECTIVE
1)TO COMPARE THE EFFICACY OF NIMBAPATRADI CHURNA DHOOPA YOGA WITH NIRGUNDYADI CHURNA DHOOPA YOGA IN THE MANAGEMENT OF DUSHTAVRANA . 2)TO STUDY THE DUSHTAVRANA IN DETAIL.
PARTCIPANTS : 60 PATIENTS DIAGNOSED WITH INFECTED WOUND MEETING INCLUSION AND EXCLUSION CRITERIA FROM SHALYATANTRA DEPARTMENT OF LATE.KEDARI REDEKAR AYURVED MAHAVIDALAYA GADHIBGLAJ ,KOLHAPUR.
INTERVENTION - 30 PATIENTS ADMINISTERED WITH NIBAPATRADI DHOOP YOGA . 30 PATIENTS ADMINISTERED WTH NIRGUNDYADI DHOOP YOGA . PRIMARY OUTCOME - REDUCE THE SIGNS AND SYMPTOMS OF DUSHTA VRANA. SECONDARY OUTCOME - NIMBAPATRADI DHOOPA YOGA IS MORE EFFECTIVE THAN NIRGUNDYADI DHOOPA YOGA IN HEALING WOUND
ANALYSIS - DATA WILL BE ANALYSED USING APPROPRAITE STATISTICAL METHODS TO COMPARE THE EFFECTIVENESS OF THE INTERVENTION ON THE PRIMARY AND SECONDARY OUTCOMES.
ETHICAL CONSIDERATIONS - THE STUDY WILL BE CONDUCTED IN ACCORDANCE WITH ETHICAL GUIDELINES AND WITH INFORMED CONSENT FROM PARTICIPANTS.
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