| CTRI Number |
CTRI/2025/09/094411 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Gugguluadi dhoopan and karanjadi ghrita in the managment of Non healing ulcer |
|
Scientific Title of Study
|
A comparative clinical study of gugguluadi dhoopan and karanjadi ghrita in the managment of dushtha vrana w.s.r to sushruta samhita |
| 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 Divy Sharma |
| Designation |
Pg Scholar |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| Address |
O.p.d No. 7 ,Department of shalya tantra,Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
O.p.d No. 7 ,Department of shalya tantra,Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
7999522477 |
| Fax |
|
| Email |
divysharma0198@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay M Kapadnis |
| Designation |
Professor Department of Shalya Tantra |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| Address |
O.p.d No. 7 ,Department of shalya tantra,Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
O.p.d No. 7 ,Department of shalya tantra,Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
947977291 |
| Fax |
|
| Email |
drajay2912@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay M Kapadnis |
| Designation |
Professor Department of Shalya Tantra |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
| Address |
O.p.d No. 7 ,Department of shalya tantra,Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
O.p.d No. 7 ,Department of shalya tantra,Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
947977291 |
| Fax |
|
| Email |
drajay2912@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rani Dullaiya Smriti Ayurved PG College And Hospital Bhopal,Madhya Pradesh,India,462044 |
|
|
Primary Sponsor
|
| Name |
Dr Divy Sharma |
| Address |
PG Scholar Shalya Tantra Department Rani Dullaiya Smriti Ayurved PG College And Hospital Bhopal,Madhya pradesh,India,462044 |
| 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 Divy Sharma |
Rani Dullaiya Smriti Ayurved Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
OPD No 7 Department of Shalya Tantra Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal MP
Bhopal
MADHYA PRADESH |
07999522477
divysharma0198@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Rani Dullaiya Smriti Ayurved PG College And Hospital Bhopal MP |
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: Gugguladi Dhoopan, Reference: Sushrut samhita su.5/18, Route: Topical, Dosage Form: Guggulu , Dose: 10(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: Prakshalan with panchvalkal kwath and gugguladi dhoopan for 10 min | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Karanjadi Ghrita, Reference: Chakradutt Vranashoth, Route: Topical, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: Prakshalan with panchvalkal kwath dressing with karanjadi ghrita |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All types of chronic wounds (wounds more than two weeks old) patient including lacerated wound, Foul odor, discharge from the vrana |
|
| ExclusionCriteria |
| Details |
1. Patients having dushtha vrana known case of - hypertension, gangrene, deep vein
thrombosis, leprosy, tuberculosis, Syphillictic ulcer, various ulcer, tropic ulcer, bed
sores are excluded.
2. Patient below 25 years of age.
3. Uncontrolled diabetes mellitus.
4. Known case of HIV and hepatitis B.
5. Pregnancy, dushta vrana associated with asthi vidraddhi (Osteomyelities)
6. Known case of malignancy wound size more than 8cm |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessed for the efficacy in the management of Dushta Vrana |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The overall assessment of patients will be made based on the following criteria |
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)
|
03/11/2025 |
| 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="4"
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
|
The patients will be diagnosed based on history, signs &symptoms, and physical examination of dushtha vrana & presence of features of dushtha vrana. The diagnosis will be made after the inspection of elevated inflammatory markers, low growth factor activity, reduced cellular proliferation, discolouration of wound and presence of slough over wound there which suggestive for dushtha vrana |