| CTRI Number |
CTRI/2025/03/081987 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| 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
|
Efficacy Of Kalanusariadi Tail Dressing In Post Operative Wound |
|
Scientific Title of Study
|
A Randomized Clinical Trial To Understand Efficacy Of Kalanusariadi Tail Dressing In Post Operative 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 Dhanji Singh |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Parul Institute of Ayurvrd Department of Shalyatantra 4th floor Room no 403 Parul University Limda Waghodiya
Vadodara
GUJARAT
391760
India |
| Phone |
7600538254 |
| Fax |
|
| Email |
dhanjisingh126@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aswin Haridas |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Parul Institute of Ayurvrd Department of Shalyatantra 4th floor Room no 403 Parul University Limda Waghodiya
Vadodara
GUJARAT
391760
India |
| Phone |
9446023359 |
| Fax |
|
| Email |
aswin.haridas27024@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aswin Haridas |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Parul Institute of Ayurvrd Department of Shalyatantra 4th floor Room no 403 Parul University Limda Waghodiya
GUJARAT
391760
India |
| Phone |
9446023359 |
| Fax |
|
| Email |
aswin.haridas27024@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurvrd Department of Shalyatantra 4th floor Room no 403 Parul University Limbda Waghodiya Vadodara GUJARAT 391760 India |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Parul Institute of Ayurvrd Department of Shalyatantra 4th floor Room no 403 Parul University Limbda Waghodiya Vadodara GUJARAT 391760 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Dhanji Singh |
Parul Institute of Ayurved |
Parul Institute of Ayurvrd Department of Shalyatantra 4th floor Room no 403 Parul University Limda Waghodiya Vadodara
Vadodara
GUJARAT |
7600538254
dhanjisingh126@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul Institute of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T149||Unspecified injury. Ayurveda Condition: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | betadine ointment | it will be applied on wound and then dressing will be done. total 20 patients are included in this group | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: kalanusaradi taila, Reference: sushruta samhita sutra sthana chap 37 shloka 27, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: it will be applied on wound and then dressing will be done. total 20 patients are included in this group |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Surgical wounds Clean wound Clean contaminated wound Patients will fully give informed consent
The surgical wound will be selected irrespective of gender religion occupation and socioeconomic status
The wound size should be a minimum of 3 cm and a maximum of 20 cm. |
|
| ExclusionCriteria |
| Details |
Infected skin (any fungal infection )
HIV,HBsAg,VDRL positive
Burns
Uncontrolled Diabetes mellitus
Osteomyelitis
Anaemia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate the efiicacy of kalanusaradi taila |
total 5 follow up are there after 1 st day then nxt will be on 3rd 5th 7th 14th and 21th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To enhance wound healing, accelerate the healing process, & minimize scar formation, appropriate therapeutic interventions & scientific approaches should be employed. |
total 5 follow up are there after 1 st day then nxt will be on 3rd 5th 7th 14th & 21th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
23/04/2025 |
| 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 - NO
|
|
Brief Summary
|
Classical text books of Ayurveda and the published works on various scientific journals are reviewed for documenting the information about wound healing properties of ingredients of Ropana Taila. Randomization – computer-generated randomization Groups- 2 Study type- interventional clinical study Study duration- 7 days Follow up time 14 days Total study duration 21 days Days of assessment post op day1, 3,5,7, 14 and 21 |