| CTRI Number |
CTRI/2025/05/086680 [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
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the efficacy of apamargadi ghee in the management of wound with special reference to utsadana upakarama |
|
Scientific Title of Study
|
To evaluate the efficacy of apamargadi ghrita in the management of wound with special reference to utsadana upakarama |
| 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 Shubham Sharma |
| Designation |
Pg scholar department of Shalyatantra |
| Affiliation |
Sri sai ayurvedic pg medical college and hospital |
| Address |
A2 Professor colony Ramghat Road Aligarh- 202001
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9027597771 |
| Fax |
|
| Email |
dr.shubh2512@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR GUNJAN KESHRI |
| Designation |
ASSOCIATE PROFESSOR Department of Shalyatantra |
| Affiliation |
Prem raghu ayurvedic medical college |
| Address |
F 2 Teachers Colony Prem raghu ayurvedic medical college
Hathras
UTTAR PRADESH
204101
India |
| Phone |
7722088407 |
| Fax |
|
| Email |
keshri.gunjan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR GUNJAN KESHRI |
| Designation |
ASSOCIATE PROFESSOR Department of Shalyatantra |
| Affiliation |
Prem raghu ayurvedic medical college |
| Address |
F 2 Teachers Colony Prem raghu ayurvedic medical college
Hathras
UTTAR PRADESH
204101
India |
| Phone |
7722088407 |
| Fax |
|
| Email |
keshri.gunjan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Shubham sharma |
Sri sai ayurvedic pg medical college and hospital |
Opposite phal mandi sarsol aligarh 202001
Aligarh
UTTAR PRADESH |
9027597771
dr.shubh2512@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTE SRI SAI AYURVEDIC PG MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L979||Non-pressure chronic ulcer of unspecified part of lower leg. Ayurveda Condition: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | utsAdana-karma, उत्सादन-कर्म | (Procedure Reference: shusruta chikitsasathana 1, Procedure details: prepared medicione will be applied over the wound)
(1) Medicine Name: apamargadi ghrita, Reference: shusrut sutrastana 37, Route: Topical, Dosage Form: Ghrita, Dose: 1(NA), Frequency: od, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient irrespective of age and sex will be selected.
2. Patients irrespective of religion, marital status and educational status will be
selected.
3. Patients suffering from Tubercular ulcers, Burn ulcers, Leprotic ulcer
4. Wound surface area 1-7 cm |
|
| ExclusionCriteria |
| Details |
1. Wounds with systemic involvement and morbid changes.
2. Suturing wounds.
3. Wound with visceral boney & spinal injuries.
4. Diabetic Patients.
5. Wound, will not be taken with involvement of bone & muscles.
6. Infected / pus discharge wound. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome is reduction in pain, Discharge, Slough Tissue at wound site.
|
assesment will be done on 1stday,7th day,14th day,21th day,28thday |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="15"
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 1 |
|
Date of First Enrollment (India)
|
31/05/2025 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This random clinical trial focuses on the traditional wound healing method (utsadan upkrama) and their comparative efficacy with standard antiseptics to be used in wound healing .This incooprates both ayurvedic and modern medical concept of wound healing. this clinical tral is aimed too find out wether this ayurvedic intervention is better in the management of wound care in comparision to the standard care and to provide a scientific data to prove it. |