| CTRI Number |
CTRI/2025/06/088945 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
12/06/2025 |
| 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
|
Efficacy of Nimbapatradi churna dhoopana and Nirgundyadi churna dhoopana in the management of dushta vrana(non healing ulcer) |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Nimbapatradi churna dhoopana and Nirgundyadi churna dhoopana in the management of dushta vrana (non healing ulcer) |
| 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 Vaibhav Topaji Avhad |
| Designation |
Postgraduate resident |
| Affiliation |
Dr N.A.Magadum Ayurvedic Medical College,Hospital and research centre |
| Address |
Dr N.A.Magadum Ayurvedic Hospital Dept of Shalya tantra, OPD no. 4, Ankali Tq-Chikodi Dist-Belagavi
Belgaum,Karnataka 591213 India
Belgaum
KARNATAKA
591213
India |
| Phone |
8380813362 |
| Fax |
|
| Email |
vaibhavavhad777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shaista Jamadar |
| Designation |
Associate Professor |
| Affiliation |
Dr N.A.Magadum Ayurvedic Medical College,Hospital and research centre |
| Address |
Dr N.A.Magadum Ayurvedic Hospital, Dept of Shalya tantra, OPD no 4, Ankali
Tq-Chikodi Dist-Belagavi
Belgaum,Karnataka 591213
Belgaum
KARNATAKA
591213
India |
| Phone |
8380813362 |
| Fax |
|
| Email |
Rajshaista786@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaibhav Topaji Avhad |
| Designation |
Postgraduate resident |
| Affiliation |
Dr N.A.Magadum Ayurvedic Medical College,Hospital and research centre |
| Address |
Dr N.A.Magadum Ayurvedic Hospital, Dept of Shalya tantra, OPD no 4, Ankali
Tq-Chikodi Dist-Belagavi
Belgaum,Karnataka 591213 India
Belgaum
KARNATAKA
591213
India |
| Phone |
8380813362 |
| Fax |
|
| Email |
vaibhavavhad777@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr N.A.Magadum Ayurvedic Medical College,Hospital and research centre, Ankali- 591213, Tq- chikodi Dist- Belagavi, karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Vaibhav Topaji Avhad |
| Address |
Dr N A Magadum ayurvedic medical College hospital and research centre, Dept of Shalya tantra, OPD NO 4,Ankali - 591213 Tq-Chikodi Dist-Belgavi, Karnataka, India |
| Type of Sponsor |
Other [] |
|
|
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 Vaibhav Topaji Avhad |
Dr N A Magadum Ayurvedic Medical college hospital and Research centre |
Dr N A Magadum Ayurvedic Medical Hospital and Research Centre, OPD no 4,Dept of Shalya tantra, Ankali- 591213,Tq- Chikodi Dist- Belagavi, Karnataka, India
Belgaum
KARNATAKA |
8380813362
vaibhavavhad777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR NAMAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | dhUpana, धूपन | (Procedure Reference: Sushruta samhita , Procedure details: churna of nimbapatra, vacha, hingu, lavana & sarshapa will be taken in equal quantity mixed with ghrita & poured on coal dhupana will be done to vrana using dhupana yantra, fumes are exposed to wound for 15 minutes.)
| | 2 | Comparator Arm | Procedure | - | dhUpana, धूपन | (Procedure Reference: sushruta samhita, Procedure details: churna of nirgundi, nimba, devadaru, sarshapa, shuddha haratal, ghruta, sharakara, madhu will be taken in equal quantity mixed with ghrita & poured on coal dhupana will be done to vrana using dhupana yantra, fumes are exposed to wound for 15 minutes.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
all patients diagnosed with lakshana of dushta vrana, ulcer size 3 to 10cm, all type of no specific ulcer will be included |
|
| ExclusionCriteria |
| Details |
lepromatous ulcer, malignant ulcer, uncontrolled DM, chronic non healing wounds, seropositive patient, tubercular ulcer, patients with systematic disorder, pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to reduce prolonged wound healing duration, to remove dead tissue and to promote healthy granulation tissue |
to reduce prolonged wound healing duration, to remove dead tissue and to promote healthy granulation tissue |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| wound discharge , foul smell & size of the ulcer measured by wound tracing method or clock method |
56 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)
|
24/06/2025 |
| 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
|
present study title "A Comparative Clinical Study to Evaluate the efficacy of Nimbapatradi churna dhupana and Nirgundyadi churna dhupana in the management of dushtavrana (Non healing ulcer)" will be conducted on 60 subjects with 30 in each group with mentioned objective and subjective parameters. one group will be treated with Nimbapatradi churna dhupana and other group with Nirgundyadi churna dhupana. Assesment of patient will be done brfore and after treatment |