| CTRI Number |
CTRI/2022/01/039874 [Registered on: 31/01/2022] Trial Registered Prospectively |
| Last Modified On: |
27/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study efficacy of Karpoora ghrita vikeshika in comparison with chlorhexidine acetate tulle gras dressing in shuddha vrana |
|
Scientific Title of Study
|
Randomized control study of efficacy of Karpoora ghrita vikeshika in comparison with chlorhexidine acetate tulle gras dressing in shuddha vrana |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Monali Panjabrao Deshmukh |
| Designation |
PG Scholar |
| Affiliation |
Seth Tarachand Ramnath Charitable Ayurvedic Hospital |
| Address |
Shalyatantra Department, 1st floor, Tilak Ayurveda Mahavidyalaya, 583/2, Rasta Peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
8421634189 |
| Fax |
|
| Email |
deshmukh.monali.14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Nitin Dattatray Nalawade |
| Designation |
Associate Professor |
| Affiliation |
Seth Tarachand Ramnath Charitable Ayurvedic Hospital |
| Address |
Department of Shalyatantra, 1st floor, Tilak Ayurveda Mahavidyalaya, 583/2, Rasta Peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9822522905 |
| Fax |
|
| Email |
nalawadenitin54@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Monali Panjabrao Deshmukh |
| Designation |
PG Scholar |
| Affiliation |
Seth Tarachand Ramnath Charitable Ayurvedic Hospital |
| Address |
Department of Shalyatantra, 1st Floor,Tilak Ayurveda Mahavidyalaya, 583/2, Rasta Peth, Pune, Maharashtra- 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
8421634189 |
| Fax |
|
| Email |
deshmukh.monali.14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurveda Mahavidyalaya, Rasta Peth, Pune-411011 |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurveda Mahavidyalaya |
| Address |
Tilak Ayurveda Mahavidyalaya, 583/2, Rasta Peth, Pune-411011 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Vd Monali Panjabrao Deshmukh |
Seth Tarachand Ramnath Charitable Ayurvedic Hospital |
Seth Tarachand Ramnath Charitable Ayurvedic Hospital, 580/2, Rasta Peth, Pune, Maharashtra-411011
Pune
MAHARASHTRA |
8421634189
deshmukh.monali.14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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:T148||Other injury of unspecified body region. Ayurveda Condition: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Karpoora Ghrita, Reference: NA, Route: Topical, Dosage Form: Ghrita, Dose: 1(NA), Frequency: sos, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: Vikeshika can be consider as sofra tulle dressing | | 2 | Comparator Arm (Non Ayurveda) | | - | Chlorhexidine tulle gras dressing | Chlorhexidine Gauze Dressing is a sterile medicated Tulle-Gras dressing composed of Leno Weave Gauze, White Soft Paraffin and Chlorhexidine Acetate 0.5%. The action of chlorhexidine acetate acts against a wide range of gram positive and gram negative bacteria. This dressing is used for prevention of infection in skin loss lesions.
|
|
|
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Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients ready to give written consent will be selected.
2) Patients having ShuddhaVrana irrespective of sex, age, occupation.
3) Wound having dimensions from 1 cm to 6 cm
4) Fresh incised wounds, lacerated wounds within 24 hours will be selected.
5) Surgical wound eg. Post op. circumcision wound.
6) Uninfected wounds in process of healing will be selected.
7) Non-infected Diabetic wound with healthy granulation (BSL-R <200mg/dl).
|
|
| ExclusionCriteria |
| Details |
1) Venous, Tubercular, Ischemic, Tropical, Neurogenic, malignant ulcers.
2) Infected wounds.
3) Diabetic Wounds having discharge or slough (BSL-R>200mg/dl).
4) Patient suffering from HIV, HbsAG.
5) Wound having dimension more than 6 cm .
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study efficacy of Karpoora ghrita vikeshika in comparison with chlorhexidine acetate tulle gras dressing in shuddha vrana in 2-3 weeks |
Efficacy will be evaluated on parameters such as pariman(size), srava(discharge),
Varna(colour),
Duration of healing,
Vedana(Pain)
Daha(Burning sensation)
Sparsha asahatva(Tenderness) when all will be reduced and colour will improve, this will decide efficacy of interventional drug. |
|
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Secondary Outcome
|
|
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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)
|
01/02/2022 |
| 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="0"
Months="0"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
In Shuddha vrana, healing depends on its
drainage. As if wound doesn’t drain freely it may lead to infection of that
wound. Hence to overcome this consequences, there is a need of such dressing
which allows the wound to drain freely and besides this a, a non adhesive
property is also directed in such wounds. Chlorhexidine acetate tulle gras dressing in an example of such
dressing in modern science which is used throughout world. Thus to find out an
alternative to such dressing in ayurveda efforts has to be made. |