| CTRI Number |
CTRI/2024/08/071973 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
02/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of jalaukavacharana in non healing wound |
|
Scientific Title of Study
|
Efficacy of single sitting Jalaukavacharana in Dushta Vrana (Diabetic Foot Ulcer) on selected inflammatory Bio-markers (TNF-ALFA, IL-6) -An open label clinical trial |
| 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 Jigneshkumar Varu |
| Designation |
PG Scholar |
| Affiliation |
KAHER Shri B M K Ayurveda Mahavidyalaya and Medical research center Shahapur Belgavi |
| Address |
Department Of Shalyatantra, OPD NO - 8
Kaher Shri BMK
Ayurveda Mahavidyalaya and Medical Research
Center Shahapur Belagavi Belgaum Karnataka 590003
Belgaum
KARNATAKA
590003
India |
| Phone |
8200673661 |
| Fax |
|
| Email |
jigneshvaru7187@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep S Shindhe |
| Designation |
Professor and HOD |
| Affiliation |
KAHER Shri BMK Ayurveda Mahavidyalaya and Medical Research Center Shahapur Belagavi |
| Address |
Department Of Shalyatantra, OPD NO - 8
Kaher Shri BMK
Ayurveda Mahavidyalaya and Medical Research
Center Shahapur Belagavi Karnataka 590003
Belgaum
KARNATAKA
590003
India |
| Phone |
9986331357 |
| Fax |
|
| Email |
pshindhe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep S Shindhe |
| Designation |
Professor and HOD |
| Affiliation |
KAHER Shri BMK Ayurveda Mahavidyalaya and Medical Research Center Shahapur Belagavi belgaum |
| Address |
Department Of Shalyatantra, OPD NO - 8
Kaher Shri BMK
Ayurveda Mahavidyalaya and Medical Research
Center Shahapur Belagavi belgaum Karnataka 590003
Belgaum
KARNATAKA
590003
India |
| Phone |
9986331357 |
| Fax |
|
| Email |
pshindhe@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Ayurveda Hospital Shahapur Belagavi Karnataka India 590003 |
|
|
Primary Sponsor
|
| Name |
KLE Ayurveda Hospital |
| Address |
Shalya Tantra Dept. KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka India 590003 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr JigneshKumar Varu |
Shalya Tantra Dept. KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka India 590003 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pradeep shindhe |
KLE Ayurveda Hospital |
OPD No 08 and IPD Shalya Tantra Dept. Shahapur Belagavi Karnataka India 590003
Belgaum
KARNATAKA |
9986331357
pshindhe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insitutional Ethics Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E136||Other specified diabetes mellituswith other specified complications. Ayurveda Condition: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणमॠ| (Procedure Reference: Sushrut acharya Sushruta Samhita Sutra Sthana Ch 13 Verse 6, Edi-Kaviraj Ambika datta shastri, Hindi com mentry:AyurvedaTattvaSandipika, Chaukamba Sanskrit Sansthan Varanasi Edition, reprint 2017.PP 43, Procedure details: The patients attending the OPD and IPD of KLE Ayurveda hospital and medical research centre,belgaum with the signs and symptoms of Dushta Vrana(Diabetic Foot Ulcer) will be screened
Informed written consent will be taken from the patients and intervention will be done
Evaluation of signs and symptoms indicated for Jalaukavacharana(Leech Therapy) will be done before and after with the help of performed parameters
Jalaukavaharanac (Leech Therapy) will be done by following SOP from department of shalya tantra
Evaluation of inflammatory biomarkers TNFα, IL-6 in blood sample taken before treatment (systemic venous blood), after 24 hours (systemic venous blood) and after 7th day by (systemic venous blood)
Clinical assessment will be done before therapy (systemic venous blood), after 24hrs after therapy (systemic venous blood) and after 7th day (systemic venous blood)
)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects fulfilling Diagnostic criteria of Dusta Vrana
Subjects with Either sex between 18-60 years of age
Yogya for jalaukavacharana
Subjects with normal CT, BT and No clinical signs of Anaemia.
Controlled diabetes mellitus on medication (RBS < 140)
Grading of diabetic foot ulcers of Grade 0 to 2 by Wagner-Meggitt Classification of Diabetic Foot included.
|
|
| ExclusionCriteria |
| Details |
Subjects with H/O Hypotension,during chemotherapy,active tuberculosis, HIV I&II, HbsAG infections, severe anaemia, haemophilia, thalasamia, other diseses affecting coagulant factors of blood or any other chronic illness and pregnancy.
Subjects with K/C/O bleeding disorders.
Grading of diabetic foot ulcers of Grade 3 to 5 by Wagner-Meggitt Classification of Diabetic Foot excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Elucidation of Atyayika Chikitsa Procedures in Inflammatory biomarkers concerned to Dushta Vrana(Diabetic Foot Ulcer) |
Base line, 24hr, 7days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="15"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/09/2024 |
| 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
|
Chronic
wounds (diabetic foot ulcer) are one of the major concern in surgery from
ancient times because of various factors are associated with the wound becoming
non-healing. Acharya Sushruta has dedicated many chapters with dealing
of chronic wounds, may be because he was well aware of treating the chronic
wounds is troublesome. Incidence rate in India, the occurrence of chronic
wounds is estimated at 4.5 per 1000 population1
Contemporary science has well
described the pathophysiology and stages involved in the wound healing i.e.
haemostasis, inflammation, proliferation, and remodeling2. The wound
to become chronic, it means it has arrested in some step of wound healing. The
recent articles have shown different inflammatory mediators have major role in
delayed wound healing. In Diabetic foot ulcer TNF-𛼠has shown prolonged expression as
proinflammatory cytokine which has elevated or prolonged the inflammation in
the wound3. Similarly IL-6 is the proinflammatory cytokine which was
seen significantly high in diabetic patients with foot ulcer may be fundamental
in the development of the ulcer4.
Jaloukavcharana is one of the method
of blood letting mentioned in Ayurveda, Acharya Sushruta includes
jalouka in anushastra (Accesory sharp instrument) and indicated in the
symptoms like taapa, shotha , daha shows
pitta dosha pradhanta5 and as per studies they have anticoagulant, analgesic, antiinflammatory,
platelet inhibitory and thrombin regulatory functions as well as antimicrobial
effects and extra cellular matrix degradative effects6. In a patient
of diabetic foot there will be gross inflammation so we want see is there any
effect of Jaloukavcharana in reducing in the proinflammatory cytokine
(TNF-𛼠and IL-6) in diabetic foot ulcers. |