| CTRI Number |
CTRI/2025/01/079747 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
MANAGEMENT OF INFECTED WOUND (NON-HEALING ULCER)IN PATIENTS OF AGE GROUP 18 TO 60 YEARS BY HIGH-FREQUENCY
ELECTROTHERAPY AND AGNIKARMA |
|
Scientific Title of Study
|
MANAGEMENT OF DUSHTAVRANA (NON-HEALING ULCER)BY HIGH FREQUENCY ELECTROTHERAPY AND AGNIKARMA-A COMPARATIVE RANDOMIZED CLINICAL CONTROL STUDY IN 18 TO 60 YEARS OF AGE |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrPravin Bhaurao Chetule |
| Designation |
PG Scholar (Shalyatantra) |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and L.K.Ayurved Rugnalaya,Yavatmal |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K.Ayurved Rugnalaya,Department of Shalyatntra,Ground floor OPD No.05, Yavatmal
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9763622511 |
| Fax |
|
| Email |
pravinchetule@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVihar R Bidwai |
| Designation |
Associate Professor, M.S.(Shalya), MBA, PhD(Sch.), FARCS & PG Guide |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and L.K.Ayurved Rugnalaya,Yavatmal |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K.Ayurved Rugnalaya,Department of Shalyatntra,Ground floor OPD No.05, Yavatmal
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9822299174 |
| Fax |
|
| Email |
drviharbidwai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrPravin Bhaurao Chetule |
| Designation |
PG Scholar (Shalyatantra) |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and L.K.Ayurved Rugnalaya,Yavatmal |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K.Ayurved Rugnalaya,Department of Shalyatntra,Ground floor OPD No.05, Yavatmal
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9763622511 |
| Fax |
|
| Email |
pravinchetule@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K.Ayurved Rugnalaya, Shivaji nagar, Aarni road, Yavatmal 445001 |
|
|
Primary Sponsor
|
| Name |
DMM Ayurved Mahavidyalaya,Yavatmal |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K.Ayurved Rugnalaya, Department of Shalyatantra, Ground floor OPD No.05, Shivaji Nagar,Yavatmal, Aarni road Dist.Yavatmal 445001 |
| Type of Sponsor |
Other [(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 Pravin Bhaurao Chetule |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and L.K.Ayurved Rugnalaya,Yavatmal |
OPD NO.05 Department of Shalyatantra, Shivaji nagar, Aarni road, Yavatmal 445001
Yavatmal
MAHARASHTRA |
9763622511
pravinchetule@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee, D.M.M. Ayurved Mahavidyalaya, Yavatmal |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AGNIKARMA |
Agnikarma has been explained as one among the Anushastra & Upayantra. Aacharya Sushrut had
mentioned that a disease once treated by agnikarma does not re-occur and does not
get infected easily. Therefore, Agnikarma has emerged as an integral part of Ayurvedic
therapeutics.
Through the mechanism of Agnikarma procedure reduce vaat,kapha from ulcer site and vacularization done in surrounding area as well as accelerate the blood circulation,Improve metabolism,reduce pain and inflamation from site. |
| Intervention |
HIGH-FREQUENCY ELECTROTHERAPY |
The high frequency is used for skin, scalp and body treatment which has many benefits
including treating acne, enlarged pores, fine lines, wounds and ulcers.
The high frequency is through the high frequency electricity rate coagulation,urges the eqidermal cell necrosis,Which can be in instantaneous thoroughly eliminate all kinds blockages from blood vessels and improve wound healing process.
It produces the ozone for sterilization,can help wound to heal.
Accelerate blood circulation and improve metabolism. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. The patients of the age group 18-60 years.
2. The patients with symptoms of Dushtavrana irrespective of its dosha E.g.Shul,
Kandu, Strava, Gandh, Sparshasahtva.
3. Patients of any sex will be selected.
4. Marital Status – Both
5. Patient only of pre-diagnosed Dushtavrana.
6. Patient belonging to any socio-economic class. |
|
| ExclusionCriteria |
| Details |
1. Age group below 18 years and above 60 years.
2. Pregnant and lactating mother.
3. Patients with other systemic diseases such as AIDS, TB, Diabetes Mellitus,
Malignancy, and Leprosy may affect the outcome of the treatment.
4. Ulcers with gangrenous changes.
5. Patient not willing to participate in study.
6. Osteomyelitis wounds.
7. Dagdha Vrana. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The parameters will be noted down before and after treatment.
1. Vedana (Severity of pain)
2. Kandu (Itching)
3. Gandh (Smell)
4. Strava (Discharge)
5. Sparshasahtva (Tenderness) |
0th, 7th,14st and 21th (28th
follow up) and then Follow
up will be taken on 45th days
to observe recurrence) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) No improvement - 0 % relief in signs and symptoms.
2) Poor improvement - 0%-25% relief in sign and symptoms.
3) Mild improvement – 26% to 50% relief in signs and symptoms.
4) Moderate improvement – 51% to 75 % relief in signs and symptoms.
5) Marked improvement – 76% to 100% relief in signs and symptoms. |
0th, 7th,14st and 21th (28th
follow up) and then Follow
up will be taken on 45th days
to observe recurrence) |
|
|
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)
|
10/02/2025 |
| 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 Yet Recruiting |
| 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
|
A minor nonhealing ulcer may also affect a person’s daily chores, making him uncomfortable and restless. Nonhealing ulcer i.e., Vrana is considered to be the primary pathology in the field of surgery. Chronic Dustavranas which are found commonly now a days become a challenge to the medical community and trying to find out solutions. Growth of micro-organism i.e., secondary infections in the nonhealing ulcer has led to the indiscriminate and irritational use of antibiotics due to which resistant strains of micro-organism developed, making the use of antibiotics futile. Sushruta the father of surgery has scientifically classified in a systemic manner the properties of the wealth of clinical material and the principles of management of Vrana which is valuable and validated even today. The classification of nonhealing ulcers, their prognostic evaluation and management, insistence on primary suturing in clean wounds, avoidance of sepsis and excision of extruded omentum and careful suturing of intestinal perforation in the management of perforation are examples cited. Sushruta has emphasized total management of the Vrana from the earliest stage of vitiation of Dosha to total recovery in which he insisted on bringing back the site of the lesion to normally in cases of Vrana treatment.
Agnikarma has been explained as one among the Anushastra & Upayantra. He further mentioned that a disease once treated by Agnikarma does not re-occur and does not get infected easily. Therefore, Agnikarma has emerged as an integral part of Ayurvedic therapeutics. |