| CTRI Number |
CTRI/2024/09/074025 [Registered on: 19/09/2024] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Other (Specify) [local application] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial to see the effect of Yava kalka (Yava paste with Ghee) lepa in Dushta vrana(Non-healing wound). |
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Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of Yava kalka lepa in Dushta vrana(Non-healing wound). |
| Trial Acronym |
NIL |
|
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 |
Dr Shah Nausheen Firdose Hafiz Abdul Azeem |
| Designation |
PG student Department of Shalya Tantra |
| Affiliation |
M.U.H.S Nashik. |
| Address |
OPD no 16 Department Shalya tantra CSMSS Ayurveda Mahavidayalya ,Kanchanwadi, Chhatrapati Sambhaji Nagar Aurangabad.
Aurangabad MAHARASHTRA 431011 India |
| Phone |
9561467867 |
| Fax |
|
| Email |
shahnausheenfirdose@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. More S.V. |
| Designation |
Assosiate professor & PG Guide Department Shalya tantra |
| Affiliation |
M.U.H.S Nashik. |
| Address |
OPD no 16 Department of Shalya tantra CSMSS Ayurveda Mahavidayalya and hospital Kanchanwadi, Chhatrapati Sambhaji nagar ,Aurangabad.
Aurangabad MAHARASHTRA 431011 India |
| Phone |
8983357106 |
| Fax |
|
| Email |
dr.swapnilmore23@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shah Nausheen Firdose Hafiz Abdul Azeem |
| Designation |
PG student Department Shalya tantra |
| Affiliation |
M.U.H.S Nashik. |
| Address |
OPD no 16 Department of Shalya tantra CSMSS Ayurveda Mahavidayalya Kanchanwadi Chhatrapati Sambhaji nagar Aurangabad.
Aurangabad MAHARASHTRA 431011 India |
| Phone |
9561467867 |
| Fax |
|
| Email |
shahnausheenfirdose@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSMSS Ayurveda Mahavidayalya va Rugnalya Aurangabad 431001 Maharashtra India. |
|
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Primary Sponsor
|
| Name |
Dr Shah Nausheen Firdose Hafiz Abdul Azeem |
| Address |
OPD no Department of Shalya tantra CSMSS Ayurved Mahavidayalya Chhatrapati Sambhajinagar, Aurangabad, 431011 Maharashtra India. |
| Type of Sponsor |
Other [Self] |
|
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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 Shah Nausheen Firdose Hafiz Abdul Azeem |
CSMSS Ayurveda Mahavidayalya va Rugnalaya |
Opd no 16 Department Shalya tantra C.S.M.S.S Ayurved Mahavidayalya Rugnalaya Chhatrapati Sambhaji nagar.431011. Aurangabad MAHARASHTRA |
9561467867
shahnausheenfirdose@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CSMSS ayurveda mahavidayalya kanchanwadi chhatrapati sambhaji nagar |
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:L984||Non-pressure chronic ulcer of skin, not elsewhere classified. Ayurveda Condition: DUSHTAVRANAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | vraNasyaShaShTi-upakramAH, वà¥à¤°à¤£à¤¸à¥à¤¯à¤·à¤·à¥à¤Ÿà¤¿-उपकà¥à¤°à¤®à¤¾à¤ƒ kalkaH lepa | (Procedure Reference: Sushruta samhita Chikitsasthan chapter 1 Dwivraniya adhyay verse 70,Vranasya shashti upkarm kalka lepa, Procedure details: After initial assessment wound will be cleaned,debries will be removed by bed side if present wound will be washed with Triphala kwath. • Yava kalka will be applied on wound . • According to Rutuchariya,Vrana Dosha pradhanta & vyakti prakruti,bandh will be applied and dressing will be done. • Application will be done on an every day as per Rutucharya. • Assessment will be done on 1st,7th,14th ,21st ,28th day of treatment)) (1) Medicine Name: Yava , Reference: Bhavprakash samhita volume purvakhand chapter dhanya varga verse 28 to 30, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 5(mg), Frequency: od, Duration: 28 Days | | 2 | Comparator Arm | Procedure | - | vraNasyaShaShTi-upakramAH, वà¥à¤°à¤£à¤¸à¥à¤¯à¤·à¤·à¥à¤Ÿà¤¿-उपकà¥à¤°à¤®à¤¾à¤ƒkalkaH lepa | (Procedure Reference: Sushruta samhita chikitsasthan chapter 1 Dwivraniya adhyay verse 70, Procedure details: After initial assessment Wound will be cleaned exudate will be removed by pressing debries will be removed by bed side if present
Wound will be cleaned & washed with Triphala kwath.Paste will be applied on wound According to Rutuchariya,Vrana dosha pradhanta and Vyakti prakruti,bandh will be applied and dressing will be done.
Application will be done on an everyday as per and dressing will be done Assessment will be done on 1st,7th,14th ,21st ,28th day of treatment)) (1) Medicine Name: TILA, Reference: Bhavprakash samhita volume purvakhand chapterTailvarg, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 5(mg), Frequency: od, Duration: 28 Days |
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Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Diagnosed cases of Dushta vrana.
2) Patients of age group 17to 60.
3) Vrana of size 50x50x10 mm not more then it.
4) Patients irrespective of sex, religion, socioeconomic status, profession will be selected.
|
|
| ExclusionCriteria |
| Details |
1) Asadhya vrana .
2) Dushta vrana with no any co-morbidity along.
3) Patients having Tropical Ulcers and Ulcers due to burn and Animal bite.
4) Wound size more than 50x50x10mm.
5) Not less than 17 yr and more than 60 yrs.
• Withdrawal criteria
1) During course of study if any serious condition occurs or if any adverse event requires urgent treatment OR withdrawal criteria
2) If patient not willing to continue
3) Patients with irregular follow up
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Yava kalka on Dushta vrana Non healing wound like decrease in size,smell, discharge. |
assesment will be done on base line and on 1st ,7th ,14th, 28th day of application |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To study diffrence between efficacy of Yava kalka & Tila kalka in Dushtavrana size smell & discharge with comparing rate of healing & cost .watch change in color & shape after treatment |
to asses above criteria at base line & on 1st,7th,14th,28th day of local application |
|
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Target Sample Size
|
Total Sample Size="92" Sample Size from India="92"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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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
|
· The Aim of Ayurveda is “Swasthasya swasth rakshanam {to promote and protect the health of healthy person} and Aturasya vikar prashaman {to treat the diseased one}. · Shalya is the branch of Ayurveda dealing with Grass, Wound, Stone, Dust,Iron, Soil,Bone, Hair,Nail,Pus discharge,Infected wound,Foreign body,Dead fetus removal and dealing with Yantra ,Shastra karm Kshar Agnikarm therapies and to observe and asess and treat Aam Pachyaman and Pakwa awastha of Vrana is called Shalya tantra. · As it is clear by Shalya tantra definition Vrana is important part of it · Detailed discription of types of Vrana there explaination and treatment has been explained very briefly in dwi-vraniya adhyay of Chikitsa sthan of Sushrut samhita. In Dwi vraniya adhyay of Sushrut samhita treatment of wound is given by Shashti upkramas. · Vrana means Spliting or tearing of body (causing discontinuity of skin and other tissues under it).as per sushruta samhita chikitsa sthan chapter 1 verse 6.it here Acharya Sushruta also explained Shashti upakramas(i.e 60 management skills of wound ) in which Sushrut acharya explained the lepan karm also. · In this Shashti upkaram 29th karm is kalk application for Shodhan and Ropan of vrana “In case of Wound of which slough is removed which are located in muscles and do not heal ,healing paste of Sesamum mixed with Honey should be applied.†After that ,Sushruta Acharya mentioned that some scholars says paste of barely similar to that of Sesamum .it pacifies the unripe and ripen the semi ripe ,ruptures the ripened one and cleanses and heals the ruptured Wound. · In other context acharya Charak also explained in 25th chapter of chikitsa sthan The wound which are painful hard stiff and without discharge should be pasted frequently with barely powder mixed with ghrita . WOUND The definition of a Wound is damage to the integrity of biological tissue, including skin, mucous membranes, and organ tissues. Non-healing Wound A wound that does not heal in an orderly set of stages and in a predictable amount of time Signs of Non-healing Wound 1. Foul Odor 2. Smelling and Thick Discharge 3. Swelling or Redness 4. Fever 5. Hot Skin · Rationale of study : · The Prevalence of wounds is 15.03 per 1000. The Prevalences of Acute and Chronic wounds were 10.55 and 4.48 per 1000 of the Population respectively · Barley production is on very large amount in India so we can make cheapest wound care product from it India ranks 22nd in Barley production worldwide. · We need more Ayurveda local drug applications on wound which should be Cheap, Non- invasive, Not causing any side effect, Easily available to all Socio-economic classes. · To cope up with other pathies it is need of the hour for Ayurveda to make evidence based medicine in such diseases for universal acquiescence . · And to prove valuable hidden treasures of Ayurveda literature Samhitas as source of evidance based research in Samhita kaal. · Inadequate and inappropriate treatment of acute wounds is the commonest cause of chronic wounds. · The other major area of concern for wound care physicians is a limited knowledge of the physiological processes involved in wound healing. |