| CTRI Number |
CTRI/2025/05/086682 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
09/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To test if Paranthyadi Taila helps reduce pain and wound size in patients with infected wounds within 21 days. |
|
Scientific Title of Study
|
An Exploratory Clinical Trial to study the efficacy of ParanthyadiTaila in the management of dushtavrana |
| 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 Brinda Suresh Patil |
| Designation |
PG scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Third
floor,Shalyatantra department Sector no.25 Pradhikaran, Nigdi
Pune
MAHARASHTRA
411044
India
Pune
MAHARASHTRA
411044
India |
| Phone |
9175482327 |
| Fax |
|
| Email |
brindapatil07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharat K Oza |
| Designation |
Associate professor |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Third
floor,Shalyatantra department Sector no.25 Pradhikaran, Nigdi
Pune
MAHARASHTRA
411044
India
Pune
MAHARASHTRA
411044
India |
| Phone |
9970254593 |
| Fax |
|
| Email |
drbharat_oza@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharat K Oza |
| Designation |
Associate professor |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Third
floor,Shalyatantra department Sector no.25 Pradhikaran, Nigdi
Pune
MAHARASHTRA
411044
India
MAHARASHTRA
411044
India |
| Phone |
9970254593 |
| Fax |
|
| Email |
drbharat_oza@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre,Third floor,Shalyatantra department
Sector no.25,Pradhikaran,Nigdi Pune Maharashtra 411044 india |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Centre Nigi Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Third floor,Shalyatantra
department Sector no.25,Nigdi Pradhikaran,Pune 411044 Maharastra
,India |
| 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 Brinda Suresh Patil |
Ayurved Rugnalya and Snowbell Multi-speciality Hospital,Nigdi,Pune |
Ayurved Rugnalaya
and Snowbell Multi
speciality Hospital,
Shalyatantra
Department, OPD No
123A Pradhikaran
Nigdi Pune
Pune
MAHARASHTRA 411044
India
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9175482327
brindapatil07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: ParanthyadiTaila, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -No Any |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with symptom of Shula, Puyadi Strava.
Age group between 18-60 yr
K/C/O Bed sores
Post operative infected wound / Infected traumatic wound
Wound size Up to 9x9 cm |
|
| ExclusionCriteria |
| Details |
Non specific Non healing ulcers
Gangrenous wounds
K/C/O HIV,HbsAg,tuberculous positive,leprosy
All Medico legal cases will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The effect of ParanthyadiTaila will be accessed for local application in dushtavrana
assessment will be done by criteria like Vranatala (floor), Smell (gandha), discharge (strava), vrana kathinya, sthanik aushnya, pain, vrana pariman. |
Follow up with assessment of
patient on 7th,14th,22nd day |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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)
|
16/06/2025 |
| 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="0"
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
|
In Ayurveda there are many ways explained by Acharya Sushruta for management of dushtavrana.Vrana means destruction or damage of a tissue in a particular part of body. recently there are so many research being conducted all over the world to treat different type of wounds. There are many factors that affect wound healing such as- age, nutrition, site of wound, life style and health condition like diabetes mellitus and Anemia etc. The word vrana is derived from Sanskrit verb root, vru-vrunotiit means to cover or to protect.“Gatra” mean as body, “Vichurnane” mean destruction, break, rupture and discontinuity (of the body or tissue). Combinedly the destruction, break, rupture, discontinuity of body, tissue or specific part of body, is called “ulcer.”Wound is described as a break in the integrity of the skin or tissues often, which may be associated with disruption of the structure and function. Dustameans Involvement of Dosha DustaVrana– The Vrana having involvement of dosha.The aim of treating dushtavrana is to either shorten the time of healing or to minimize the undesired consequences, Acharya Sushruta has described the 60 types of treatment & 7 type of Upakram for wound management from its manifestation to the complete healing. Also given much importance to shodhana and ropana in the management of DushtaVrana. To investigate the therapeutic potential of Paranthyaditaila in the management of dushtavrana debilitating condition characterized by chronic wounds, by examining its anti inflammatory ,antimicrobial and wound healing properties and its impact on patient outcomes and quality of life Topical application of ParanthyadiTaila has proven to be highly effective in treating infected wounds (DustaVrana), promoting wound cleansing (Vranshodhan) and healing (Vranropan). The local application procedure is not only safe but also easy to administer, feasible, and equally effective compared to other treatments for managing infected wounds. Therefore, this formulation has been chosen for present study. |