| CTRI Number |
CTRI/2025/04/084301 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
05/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Vrana Dhavan and Pichu Dharan] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the efficacy of external application of Patoladi Kwath and Kampillak Taila for healing of Dushta Vrana |
|
Scientific Title of Study
|
Randomized open controlled clinical study to assess the efficacy of Patoladi Kwath and Kampillak Taila in management of Dushta Vrana with special reference to Infected Wound |
| 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 Vishal Devendra Tarole |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli |
| Address |
OPD No 4 Shalyatantra department 2nd floor Yashwant Ayurvedic
College Post Graduate Training and Research Center, Tal Panhala,
Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8275557557 |
| Fax |
|
| Email |
vishaltarole@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srinivas Narsimha Turlapati |
| Designation |
PG Guide |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli |
| Address |
OPD No 4 Shalyatantra department 2nd floor Yashwant Ayurvedic
College Post Graduate Training and Research Center, Tal Panhala,
Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9503147698 |
| Fax |
|
| Email |
drsrinivast@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srinivas Narsimha Turlapati |
| Designation |
PG Guide |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli |
| Address |
OPD No 4 Shalyatantra department 2nd floor Yashwant Ayurvedic
College Post Graduate Training and Research Center, Tal Panhala,
Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9503147698 |
| Fax |
|
| Email |
drsrinivast@gmail.com |
|
|
Source of Monetary or Material Support
|
| Daily OPD, IPD And Casualty Patients Yashwant Ayurvedic Medical college kodoli
kolhapur 416414 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Vishal Devendra Tarole |
| Address |
OPD No 4 Shalyatantra department 2nd floor Yashwant Ayurvedic
College Post Graduate Training and Research Center, Tal Panhala,
Dist Kolhapur |
| 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 Vishal Tarole |
Yashwant Dharmarth Rugnalay Kodoli |
OPD No 4 Shalyatantra department 2nd floor Yashwant Ayurvedic
College Post Graduate Training and Research Center Tal Panhala
Dist Kolhapur
Kolhapur
MAHARASHTRA |
8275557557
vishaltarole@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant Ayurvedic College PGT& RC Kodoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T149||Unspecified injury. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Dhavan and Pichu Dharan | (Procedure Reference: Vangasen Samhita and Charaka Chikitsa Sthan, Procedure details: Patoladi Kwatha will be applied over wound properly as per requirements so that it will clean whole wound
Proper cleaning and washing of wound will be achieved
Kampillaka Taila soaked guaze will be applied over wound properly
Cover the wound with sterole pad of adequate size
Once daily for 15 days)
(1) Medicine Name: Patoladi Kwatha, Reference: Vangasen Samhita, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 0(NA), Frequency: od, Duration: 15 Days(2) Medicine Name: Kampillaka Taila, Reference: Charaka Chikitsa Sthan, Route: Topical, Dosage Form: Taila, Dose: 0(NA), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Hydrogen peroxide and povidone iodine solution | Cleaning of wound will be achieved with hydrogen peroxide then povidone iodine solution applied over wound with sterile gauze wound will be covered with sterile pad and dressing done
Once daily for 15 days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient between age group 20 to 70 years
Area of wound not more than 5 X 5 cms and depth not more than 1 cms
Patient irrespective of gender, economic status and cast
Patient having sign and symptoms of Dushta Vrana w.s.r. to Infected Wound |
|
| ExclusionCriteria |
| Details |
Known casr of HIV, Hep. B, DM, HbsAg or any systemic disease
Wound having excessive loss of tissue i.e. wound include bones and tension injury, exposed bone
Patient suffering from wound like tubercular ulcer, venous ulcer, leprotic ulcer, malignant ulcer and burns |
|
|
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 |
| To study the Shodhana and Ropana effect of Patoladi Kwatha and Kampillaka Taila in Dushta Vrana |
15 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To study the Shodhana effect of Patoladi Kwatha in Dushta Vrana
2)To study the Ropana effect of Kampillaka Taila in Dushta Vrana
3) To assess improvement by sign, prognosis and gradation of assessment criteria
4)To reduce discomfort and complaints of patients
5)To achieve outcome in 15 days |
15 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
16/04/2025 |
| 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 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 25-03-2025 and end date provided 13-04-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
RANDOMIZED OPEN CONTROLLED CLINICAL STUDY TO ASSESS THE EFFICACY OF PATOLADI KWATH AND KAMPILLAK TAILA IN MANAGEMENT OF DUSHTA VRANA WITH SPECIAL REFERENCE TO INFECTED WOUND Assessment of sign and symptoms will be done on follow up days and outcome will be assessed after 15 days |