| CTRI Number |
CTRI/2025/10/095850 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of wound (Dushta-Vrana) using Kampillakadi Taila |
|
Scientific Title of Study
|
Clinical Evaluation of Kampillakadi Taila in Dushta-Vrana |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajay Kumar Gupta |
| Designation |
Professor |
| Affiliation |
Rishikul campus,Uttarakhand Ayurved University, Haridwar |
| Address |
OPD No-7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University,Haridwar
Uttarakhand 249401 India Hardwar Uttaranchal
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9412856414 |
| Fax |
|
| Email |
akg1409@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar Gupta |
| Designation |
Professor |
| Affiliation |
Rishikul campus,Uttarakhand Ayurved University, Haridwar |
| Address |
OPD No-7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University,Haridwar
Uttarakhand 249401 India Hardwar Uttaranchal
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9412856414 |
| Fax |
|
| Email |
akg1409@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nisha Bharti |
| Designation |
PG Scholar |
| Affiliation |
Rishikul campus,Uttarakhand Ayurved University, Haridwar |
| Address |
OPD No-7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University,Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9068189213 |
| Fax |
|
| Email |
nishabhartiharidwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD No. 7, Deptt. of Shalya Tantra, Rishikul Ayurved hospital, Haridwar, Uttarakhand Ayurved University, Haridwar,249401
|
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurved University |
| Address |
Uttarakhand Ayurved University,Railway Road, Harrawala, Dehradun Uttarakhand India, 248001 |
| Type of Sponsor |
Government 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 Nisha Bharti |
Rishikul Campus, Haridwar |
OPD No-7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University,Haridwar
Uttarakhand 249401 India Hardwar Uttaranchal
Hardwar
UTTARANCHAL |
09068189213
nishabhartiharidwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Uttarakhand Ayurved University, Rishikul Campus, Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T813||Disruption of wound, not elsewhereclassified. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kampillakadi Taila, Reference: Charak Samhita, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Kampillakadi Taila will be applied locally, according to the size of Dushta-Vrana with the help of Vrana-vasti 15 minutes, once daily. Dressing will be done with a sterile bandage. |
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients suffering from Dushta-Vrana (Non healing ulcers) on any part of the body.
2.Burn wounds
3.Non specific ulcers
|
|
| ExclusionCriteria |
| Details |
1.Patient with bleeding disorders
2.Known case of Syphilitic ulcers
3.Known case of Tubercular ulcers
4.Underlying case of bony lesions
5.Patients with evidence of malignancy and malignant ulcers
6.HBsAg, HIV positive patient
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain
2. Itching
3. Tenderness
4. Foul Smell
5. Floor/Granulation
6. Size
7. Discharge
|
It will be assessed every 15 days,
untill wound heal completely. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Expected improvement and healing in the non-healing wound of patients by relief in the symptoms like pain, discharges and size of the wound. |
It will be assessed every 15 days,
untill wound heal completely. |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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
|
N/A |
|
Date of First Enrollment (India)
|
24/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/10/2025 |
| 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 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
|
Non-healing ulcers are the most common problem encountered in clinics today. Ulcer is a discontinuity over the skin exhibiting loss of epidermis, dermis, and sometimes subcutaneous fat as well. In Ayurveda, Dushta-vrana can be correlated with non-healing ulcers. Acharya Sushruta detailed Dushta Vrana in Chikitsa Sthana. It is characterized by symptoms like Durgandha (foul smell), Vedana (pain), Chirakali (chronicity), Utsangi (elevated), Atipooyasrava (pus discharge), Atigandha Vrana srava, etc. All these features can be observed in non-healing ulcers. This study is an interventional, open-label, single group trial, Clinical Evaluation of Kampillakadi Taila in Dushta- Vrana. The case
will be selected randomly from OPD/IPD of Rishikul Campus Hospital, U.A.U, Haridwar (U.K.) India. The study will be intervended under one group with Kampillakadi Taila (Vrana-vasti) locally appiled, duration of trial will be 3 months, maximum. Assessment criteria will be done on subjective and
objective parameters. Subjective parameters based on pain and itching and objective parameters on tenderness, foul smell, floor/granulation, size, and discharges. |