| CTRI Number |
CTRI/2025/07/091764 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A CLINICAL COMPARATIVE STUDY TO EVALUATE THE EFFICACY OF VRANAKUTHAR TAILA AND YASHTIMADHU TAILA IN THE MANAGEMENT OF DUSHTA VRANA WITH SPECIAL REFERENCE TO CHRONIC WOUND |
|
Scientific Title of Study
|
A CLINICAL COMPARATIVE STUDY TO EVALUATE THE EFFICACY OF VRANAKUTHAR TAILA AND YASHTIMADHU TAILA IN THE MANAGEMENT OF DUSHTA VRANA W.S.R TO CHRONIC 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 Rucha Narendra Selkar |
| Designation |
PG Scholor |
| Affiliation |
Shri Babu Singh Jay Singh Ayurvedic Medical College, Farrukhabad |
| Address |
ROOM NO 315
PG ROOM DIVISION 2
DEPARTMENT OF PG STUDIES IN SHALYA TANTRA
Shri Babu Singh Jay Singh Ayurvedic Medical College, Farrukhabad
Bhaupur, bewar road Farrukhabad
Farrukhabad
UTTAR PRADESH
209625
India |
| Phone |
|
| Fax |
|
| Email |
selkarrucha25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ram Naresh Singh |
| Designation |
Associate Professor |
| Affiliation |
Shri Babu Singh Jay Singh Ayurvedic Medical College, Farrukhabad |
| Address |
ROOM NO 312
DIVISION 1 (ASSO. PROFESSOR CHAMBER)
DEPARTMENT OF SHALYA TANTRA
Shri Babu Singh Jay Singh Ayurvedic Medical College, Farrukhabad
Farrukhabad
UTTAR PRADESH
209625
India |
| Phone |
09380625759 |
| Fax |
|
| Email |
sramnaresh762@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rucha Narendra Selkar |
| Designation |
PG Scholor |
| Affiliation |
Shri Babu Singh Jay Singh Ayurvedic Medical College, Farrukhabad |
| Address |
ROOM NO 315
DIVISION 2
DEPARTMET OD SHALYA TANTRA
Shri Babu Singh Jay Singh Ayurvedic Medical College, Farrukhabad
Bewar Road, Fatehgarh Farrukhabad, Uttarpradesh
Farrukhabad
UTTAR PRADESH
209625
India |
| Phone |
09730381904 |
| Fax |
|
| Email |
selkarrucha25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Babu Singh Jay Singh Ayurvedic Medical College Farrukhabad Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Rucha Narendra Selkar |
| Address |
Shri Babu Singh Jay Singh Ayurvedic Medical College, Bewar Road, Fatehgarh, Farrukhabad |
| 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 Ram Naresh Singh |
Shri Babu Singh Jay Singh Ayurvedic Medical College, Farrukhabad |
ROOM NO 315
DIVISION 1
DEPARTMENT OF SHALYA TANTRA
Farrukhabad
UTTAR PRADESH |
09380625759
sramnaresh762@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Z768||Persons encountering health services in other specified circumstances. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: VRANAKUTHAR TAILA, Reference: RASATANTRASARA SANGRAHA AND SIDDHA PRAYOG- KHANDA 2- VRANA VIDRADHI ARBUD 28- VRANAKUTHAR TAILA, PAGE NO 348, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: YASHTIMADHU TAILA, Reference: SHARANGDAR SAMHITA MADHYAM KHANDA BY PARSHURAM SHASTRI, 9/1-2 PAGE NO 212, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from dushta vrana with complaints of pricking and tearing type pain, purulent discharge, burning sensation and itching over wound will be selected for this study.
Age group above 5 years will be selected for the study. Patients with wound size not more than 10cm x 5cm x 1 cm. Patients will be selected irrespective of sex, religion, occupation, economic and educational status.
|
|
| ExclusionCriteria |
| Details |
Patient with disorders like malignancy, HIV, HCV, HBsAg positive will be excluded. Patients with Dagdha vrana, chronic pressure ulcers with underlying bony lesions, peripheral vascular disease, pre gangrene or gangrenous, necrotic changes, osteomyelitis.Vrana over mobile joints. Systemic disordered patients like Severe anaemia, autoimmune/ immune suppressive disorders will be excluded. Chronic skin conditions like psoriasis, vasculitis, cellulitis, pyoderma gangrenosum.
|
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EFFECT OF VRANAKUTHAR TAILA MAY BE MORE THAN YASHTIMADHU TTAILA |
4 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| HEALING TIME OF VRANA KUTHARA TAILA AND YASHTIMADHU TAILA WILL BE ESTIMATED |
6 WEEKS |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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="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 (Others) -
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- 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 01-01-2026 and end date provided 31-12-2028?
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
|
This study is clinical comparative study in a randomly selected patient suffering from dushta vrana to evaluate the efficacy of vranakuthar Taila and Yashtimadhu taila over 60 patients 30 in each group. The primary measures will be effectiveness of either of the two selected drugs in vrana. the drug prescribed will be applied locally over 15 days or till the wound heals. |