| CTRI Number |
CTRI/2021/09/036453 [Registered on: 13/09/2021] Trial Registered Prospectively |
| Last Modified On: |
22/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative study of Laser therapy and compression bandage with and without Leech therapy in management of venous ulcers |
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Scientific Title of Study
|
Comparative study of Endovenous Laser Ablation (EVLA) and 4-Layer Bandage (4-LB) with Leech Therapy (Jalaukavacharana) and without Leech Therapy (Jalaukavacharana) in the management of Venous Ulcer |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAKDwivedi |
| Designation |
Assistant Professor |
| Affiliation |
Department of Shalya Tantra, IMS, BHU |
| Address |
Department of Shalya Tantra,
Faculty of Ayurveda,
Institute of Medical Sciences,
Banaras Hindu University-221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9161499774 |
| Fax |
|
| Email |
drarunbhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAKDwivedi |
| Designation |
Assistant Professor |
| Affiliation |
Department of Shalya Tantra, IMS, BHU |
| Address |
Department of Shalya Tantra,
Faculty of Ayurveda,
Institute of Medical Sciences,
Banaras Hindu University-221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
drarunbhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAKDwivedi |
| Designation |
Assistant Professor |
| Affiliation |
Department of Shalya Tantra, IMS, BHU |
| Address |
Department of Shalya Tantra,
Faculty of Ayurveda,
Institute of Medical Sciences,
Banaras Hindu University-221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
drarunbhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalya Tantra, Faculty of Ayurveda, Institute of Medical Sciences, BHU |
|
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Primary Sponsor
|
| Name |
Department of Shalya Tantra Faculty of Ayurveda IMSBHU |
| Address |
Faculty of Ayurveda,
Institute of Medical Sciences,
BHU-221005 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dushyant Mahendrakumar Parmar |
Sir Sunderlal Hospital, IMS, BHU |
OPD No. 12, 14, 16A, General Surgery OPD, Radiodiagnosis and Imaging Section, Sir Sunderlal Hospital, Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH |
9662719344
dushyantparmar123@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Ethical Committee, Institute of Medical Sciences, BHU |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: VRANAH, (2) ICD-10 Condition:I830||Varicose veins of lower extremities with ulcer. Ayurveda Condition: VRANAH, |
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणमॠ& EVLA (Endovenous Laser Ablation) | (Procedure Reference: Sushruta Samhita, Chikitsa Sthana 1/27(2)-29 & Oğuzkurt L. Endovenous laser ablation for the treatment of varicose veins. Diagn Interv Radiol. 2012 Jul-Aug;18(4):417-22. doi: 10.4261/1305-3825.DIR.5248-11.0. Epub 2011 Dec 28. PMID: 22205579., Procedure details: The patient would be treated with EVLA (Endovenous Laser Ablation) using Biohitec Laser System of 1470 nm under Spinal Anaesthesia for 25-30 minutes. This would be followed by weekly application of leech over the site of ulcer for 3 months.)
| | 2 | Intervention Arm | Procedure | - | EVLA (Endovenous Laser Ablation) | (Procedure Reference: OÄŸuzkurt L. Endovenous laser ablation for the treatment of varicose veins. Diagn Interv Radiol. 2012 Jul-Aug;18(4):417-22. doi: 10.4261/1305-3825.DIR.5248-11.0. Epub 2011 Dec 28. PMID: 22205579., Procedure details: It would be done using Biohitec Laser System using diode laser 1470 nm. Spinal Anaesthesia would be used. The whole procedure takes 25-30 minutes.)
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Any patient irrespective of sex or religion falling between 18-60 years of age
2) known case of venous ulcers irrespective of duration |
|
| ExclusionCriteria |
| Details |
1) Ulcers other than venous ulcers
2) Malignancy
3) Those allergic to local anaesthetics
4) Those having hyper-coagulable states
5) Lymphedema
6) Non-ambulatory patient
7) Those having Peripheral Arterial Insufficiency
8) Poor general health
9) Pregnant patients
10) Recent or active Thromboembolism
11) Those having Diabetes Mellitus
12) Those having Immunocompromised states
13) Those who are HIV, HBsAg and Anti-HCV Positive |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Assessment will be done on the basis of prepared proforma and improvement in signs and symptoms of Chronic Venous Diseases |
Duration: 3 months ; Follow-up would be done every 15 days (Total 6 follow ups would be done) |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in criteria as per Venous Clinical Severity Score (VCSS) and Aberdeen Venous Vein Questionnaire (AVVQ) |
Duration: 3 months; Follow-up would be done every 15 days (Total 6 follow ups would be done) |
|
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Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/09/2021 |
| Date of Study Completion (India) |
31/03/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Venous ulceration is the most sever form of Chronic Venous Disease (CVD) results in a lot of pain and suffering to the patient. Studies on venous ulcers have shown that chronic inflammation is the main cause. The pathophysiology behind the inflammation on microcirculation level is secondary to persistent elevation of ambulatory venous pressure. Endovenous Laser ablation (EVLA) is a less invasive alternative to vein stripping. Short and mid-term studies of EVLA, regardless of wavelength used, seem remarkably consistent, typically reporting ablation of refluxing saphenous veins in 90% or more of cases. Four-layer bandaging is a high compression bandaging system that incorporates elastic layers to achieve a sustained level of compression over time. Venous ulcers shows similarity with kaphaja vrana as described in Ayurvedic texts. Acharya Sushruta described Kaphaja Vrana symptoms as those characterised by constant and severe itching and thick margins; their surface is covered with rigid, membranous covering of veins and ligament outs tissue; they have a rigid base, anaemic look and are associated with mild pain; they have a whitish, cold and slimy discharge and give rise to a feeling of heaviness. Acharya Sushruta described Jalaouka Avacharana under Rakta-visravana in the context of Shashti Upakrama for management of Vrana. It is seen that leech application corrects venous hypertension, reduces vascular congestion due to presence of carboxypeptidase A inhibitors, histamine-like substances and acetylcholine in its saliva.
In present study total 40 patients of venous ulcers would be registered and would be enrolled after thorough interrogation, examination, laboratory investigations & Venous Duplex Study. They would be divided in two groups: Group A: 20 patients would be treated with EVLA followed by weekly application and changing of Four layer bandage Group B: 20 patients would be treated with EVLA followed by weekly changing of 4 layer bandage and weekly application of Leech Therapy. Venous Duplex Ultrasonography would be done before and after the completion of treatment schedule. |