| CTRI Number |
CTRI/2022/10/046884 [Registered on: 28/10/2022] Trial Registered Prospectively |
| Last Modified On: |
27/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
"It Is a Study to See Effectiveness Of Yavadi Kalka and Tiladi Kalka After Jaloukavacharana In The Management Of Dustavrana With Special Reference To Non Healing Traumatic Ulcer". |
|
Scientific Title of Study
|
"A Randomised Comparative Clinical Study to Evaluate the Efficacy of Yavadi Kalka and Tiladi Kalka after Jaloukavacharana in the Management of Dusta Vrana with special reference to Non Healing Traumatic Ulcer". |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Biradar |
| Designation |
MS scholar Dept. of shalya tantra |
| Affiliation |
BLDEAS AVS Ayurveda Mahavidhyalaya |
| Address |
BLDEAS AVS Ayurveda Mahavidyalaya, Vidya Nagar, Bagalkot Road, Vijyapura
BLDEAS AVS AMV, Vidya Nagar, Bagalkot Road, Vijyapura
Bijapur
KARNATAKA
586101
India |
| Phone |
7892925870 |
| Fax |
|
| Email |
pb28121996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pasadshakti Gannur |
| Designation |
Professor and HOD Dept. of shlya tantra |
| Affiliation |
BLDEAS AVS Ayurveda Mahavidhyalaya |
| Address |
BLDEAS AVS Ayurveda Mahavidyalaya, Vidya Nagar, Bagalkot Road, Vijyapura
BLDEAS AVS Ayurveda Mahavidyalaya, Vidya Nagar, Bagalkot Road, Vijyapura
Bijapur
KARNATAKA
586101
India |
| Phone |
9480062140 |
| Fax |
|
| Email |
pgannur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Biradar |
| Designation |
MS scholar Dept. of shalya tantra |
| Affiliation |
BLDEAS AVS Ayurveda Mahavidhyalaya |
| Address |
BLDEAS AVS Ayurveda Mahavidyalaya, Vidya Nagar, Bagalkot Road, Vijyapura
BLDEAS AVS AMV,Vidya Nagar, Bagalkot Road,Vijyapura
Bijapur
KARNATAKA
586101
India |
| Phone |
7892925870 |
| Fax |
|
| Email |
pb28121996@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDEAS AVS Ayurveda Mahavidyalaya,Vidya nagar, bagalkot Road Vijayapura 586101 Karntaka India |
|
|
Primary Sponsor
|
| Name |
BLDEAS AVS Ayurveda Mahavidyalaya |
| Address |
BLDEAS AVS Ayurveda Mahavidyalaya,Vidya nagar, bagalkot Road Vijayapura |
| Type of Sponsor |
Private medical college |
|
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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 Priyanka Biradar |
BLDEAS AVS Ayurveda Mahavidyalaya hopsital and research centre |
Department of shalyatantra, OPD No.4 Bagalkot road Vidyanagar vijayapura 586101
Bijapur
KARNATAKA |
7892925870
pb28121996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee BLDEAS AVS Ayurveda Mahavidyalaya Hospital and research centre Vijayapaura Karnataka India |
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:S00-T88||Injury, poisoning and certain other consequences of external causes. Ayurveda Condition: DUSHTAVRANAH(Non healing traumatic ulcer), (2) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DUSHTAVRANAH, |
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | kalkaH, कलà¥à¤•à¤ƒ | (Procedure Reference: Sushrut samhita chikitsa sthana *th chapter, Procedure details: Ingredients:Tila(Kalka),Nimba patra (Kalka),Madhu & ghrita.
The procedure will be carried out in aseptic condition. De-sloghing and debridement will be done if necessary. Jaloukavacaharana followed by pressure bandaging will be done on 1st day only. After 48hrs of leech therapy. ulcer will be cleaned with normal saline then Tiladi kalka will be applied over the wound once daily for 28days. sterile dressing & bandaging to be done daily.If the ulcer heals within the fixed duration then treatment)
| | 2 | Intervention Arm | Procedure | - | kalkaH, कलà¥à¤•à¤ƒ | (Procedure Reference: Sushruta Samhita chikitsa sthana 8th chapter, Procedure details: Ingredients: YAVA(churna form),Nimba patra Kalka,Madhu & ghrita.
The procedure will be carried out in aseptic condition.
De-sloghing and debridement will be done if necessary.
Jaloukavacaharana followed by pressure bandaging will be done on 1st day only.
After 48hrs of leech therapy ulcer will be cleaned with normal saline then yavadi kalka will be applied over the wound for 28days.
sterile dressing & bandaging to be done daily.If the ulcer heals within the fixed duration then treatment wil)
|
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|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient suffering from non healing traumatic ulcer
Dusta vrana with size of 10 sq.cm and having signs & symptoms of non haling ulcer(Dustaraktasrava-vitiated blood discharge)Pooti puya(pus discharge)Atee vedana(severe pain),ateeushna(locally raised tempreture)utsadan(elevated edges),raaga9redness),paaka(supporated), deerga kalen(chronic)
patients who are fit for jaloukavacharana
patients who are ready to participate & sign for inform consent form |
|
| ExclusionCriteria |
| Details |
Patient suffering from any bleeding disorders,chronic systemic disorders & infectious diseases like HIV,Hepatitis-B,HCV .
Patients of diabetic ulcer,venous ulcer,arterial ulcer,malignant ulcer,tuberculosis ulcer are excluded |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Sign and symptom of dusta vrana non healing ulcer viz. vrana vedana pain Daha burning sensation Kandu Itching Vrana gandha foul smell Vrana varna discolouration Vrana srava discharge Vrana akruti Size shape tenderness |
Sign and symptom of dusta vrana non healing ulcer viz vrana vedana pain Daha burning sensation Kandu Itching Vrana gandha foul smell Vrana varna discolouration Vrana srava discharge Vrana akruti Size shape tenderness
above said outcome measures will be assessed on weekly interval |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| effectiveness for anaerobic and aerobic bacteria |
Above said outcome measures will be assessed and recoreded on 4weeks |
|
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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)
|
20/11/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/11/2022 |
| 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 |
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Publication Details
|
none yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
this study is a open label,two arm randomizatipn active controlled clinical trail assessing the efficacy of yavadi klaka ,local application on dustavrana(non healing traumatic ulcer)once in a day(after single setting of jaloukavacharana)in 20 patients for period of 28days in our centre(BLDEAS AVS ayurveda mahavidyalaya hopsitala and research centre, Vijayapura, Karntaka,India. The primary outcome measures will be signs and symptoms of non healing ulcer compared with control group(Tiladi Kalka) which are treated with Yavadi Kalkain 20 patients in the period of 28dyas. |