| CTRI Number |
CTRI/2026/02/103876 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
15/02/2026 |
| 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
|
A Clinical Study to Assess the Role of Bhunimba Powder in Healing Chronic Non-Healing Ulcers |
|
Scientific Title of Study
|
An Open Label Double Arm Controlled Clinical Trial To Evaluate The Efficacy Of Bhunimba Avachoornana In Dushta Vrana,Chronic 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 Prathibha H C |
| Designation |
PG Scholar |
| Affiliation |
SDM Institute of Ayurveda and Hospital |
| Address |
SDM Institue of Ayurveda and Hospital, NH 275,Anchepalya, Chalagatta
Department of shalyatantra,OPD No-16,18,19,20,21 , SDM Institue of Ayurveda and Hospital, NH 275,Anchepalya, Challaghatta
SDM Institue of Ayurveda and Hospital, NH 275,Anchepalya, Chalagatta
Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9535581371 |
| Fax |
|
| Email |
prathi.sham09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shankar S |
| Designation |
Professor and HOD |
| Affiliation |
SDM Institute of Ayurveda and Hospital |
| Address |
Department of shalyatantra,OPD No-16,18,19,20,21 , SDM Institue of Ayurveda and Hospital, NH 275,Anchepalya, Challaghatta
SDM Institue of Ayurveda and Hospital, NH 275,Anchepalya, Chalagatta
Bangalore
KARNATAKA
560074
India |
| Phone |
9535581371 |
| Fax |
|
| Email |
drshankar@sdmayurbangalore.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prathibha H C |
| Designation |
PG Scholar |
| Affiliation |
SDM Institute of Ayurveda and Hospital |
| Address |
SDM Institue of Ayurveda and Hospital, NH 275,Anchepalya, Chalagatta
SDM Institue of Ayurveda and Hospital, NH 275,Anchepalya, Chalagatta
Bangalore
KARNATAKA
560074
India |
| Phone |
9535581371 |
| Fax |
|
| Email |
prathi.sham09@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Prathibha H C |
| Address |
Department of Shalyatantra,OPD No-16,18,19,20,21 SDM Institue of Ayurveda and Hospital, NH 275,Anchepalya, Challagatta, Ben560074, 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 Prathibha H C |
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital,Bangalore |
Department of shalyatantra,
OPD No-16,18,19,20,21 , SDM Institue of Ayurveda and Hospital, NH 275,Anchepalya, Challaghatta
SDM Institue of Ayurveda and Hospital, NH 275,Anchepalya, Chalagatta
Bangalore
Bangalore
KARNATAKA |
09535581371
prathi.sham09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,SDM INSTITUTE OF AYURVEDA AND HOSPITAL, BENGALURU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:PCS||. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Neosporin Dusting Powder | Procedure details:
Patient will be made to sit up/lie down to his/her comfort. Wound will be kept open.
Wound will be cleaned with Normal Saline. Wound will be mopped dry.
Neosporin Dusting Powder will be done uniformly over the wound such that the entire wound area is covered.
A sterile gauze will be placed over the wound. A sterile pad will be placed over the wound. The wound will be closed, and the dressing will be secured using a roller bandage.
Contact period: 24 hours. | | 2 | Intervention Arm | Procedure | - | Bhunimba Avachoornana | (Procedure Reference: Ashtanga Hridaya, Procedure details: Purva Karma:
Bhunimba Churna was prepared with all aseptic measures, as per the classical reference of Choorna Kalpana. After proper cleaning the drug, it made into small pieces by chopping. Using pulveriser it was made into fine powder with mesh size of 80 to 120 range. Packing done under aseptic precaution and sterilization done under UV for 20 minutes Patient will be made to sit up/lie down to his/her comfort.
Wound will be kept open.
Pradhana Karma:
Wound will be cleaned with Normal Saline.
Wound will be mopped dry.
Bhunimba Avachoornana will be done uniformly over the wound such that the entire wound area is covered.
Paschat Karma:
A sterile gauze will be placed over the wound.
A sterile pad will be placed over the wound.
The wound will be closed, and the dressing will be secured using a roller bandage.
Contact period: 24 hours.
)
(1) Medicine Name: Bhunimba, Reference: Ashtanga Hridaya, Route: Topical, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient diagnosed with Dushtavrana having the features of Vrana presenting with Durgandha, Puya Shrava, Vedana and Daha.
2.Age between 20 to 60 years irrespective of gender, religion, place and socio-economic status.
3.Ulcer size within 5-cm length x breadth and 1-2cm depth
4.Chronicity up to one year. |
|
| ExclusionCriteria |
| Details |
Patient aged about 60 years.
Patient with Tuberculosis,Malignancy,Severe bleeding disorders,Multiple Ulcers ,Gangrene wound in specific areas like joints,bones and Diabetic mellitus HbA1C greater than 8 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Changes in the status of Dushtavrana.
2.Reduction in Circumference of the wound Length, Width and Depth.
3.Reduction in Exudate quantity, Odour, Pain and Slough
4.Formation of Granulation Tissue.
5.four weeks |
1.Changes in the status of Dushtavrana.
2.Reduction in Circumference of the wound Length, Width and Depth
3.Reduction in Exudate quantity, Odour, Pain and Slough
4.Formation of Granulation Tissue.
5.four weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the quality of life. |
14 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
26/02/2026 |
| 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
|
Title:
An
open-label, double-arm controlled clinical trial is planned to evaluate the
efficacy of Bhunimba Avachurnana in the management of Dushta
Vrana (chronic non-healing ulcer). A total of 15 patients will be
included in the study and allocated into two groups.
Study
Design and Intervention
Group A (Trial Group): External application of Bhunimba
Churna as Bhunimba Avachoornana
Group B (Control Group): External application
of Neosporin Dusting Powder
Procedure: Dusting of the respective drug uniformly over the
wound area
Contact Period: 24 hours
Duration of Treatment: 7 days
Assessment: Dressing will be done daily for 7 days and final
assessment will be carried out on the 8th day
Bhunimba
Avachoornana Procedure
Purva Karma: Bhunimba Churna is prepared under aseptic
conditions following classical Choorna
Kalpana methods. The wound is kept open and the patient positioned
comfortably.
Pradhana Karma: The wound is cleaned with normal saline,
mopped dry, and Bhunimba Avachoornana is uniformly dusted over the entire wound
surface.
Paschat Karma: A sterile gauze and pad are applied, followed
by secure bandaging. The drug remains in contact with the wound for 24 hours.
Outcome
Measures
Primary Objective Parameter: Assessment based on
the Bates-Jensen Wound Assessment Tool
Secondary Parameters:
- Vedana (pain)
- Durgandha (foul smell)
- Puya Srava (discharge)
Conclusion
This study
aims to scientifically assess the wound-healing efficacy of Bhunimba
Avachoornana in Dushta Vrana and compare its effectiveness with a standard
control drug using validated wound assessment parameters and appropriate
statistical method |