| CTRI Number |
CTRI/2021/12/038403 [Registered on: 03/12/2021] Trial Registered Prospectively |
| Last Modified On: |
02/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This study of dushta vrana cure with the help of nimbaadi taila make comparision with eusol liquid |
|
Scientific Title of Study
|
“ RANDOMIZED CLINICAL TRIAL TO ASSESS THE EFFICACY OF NIMBAADI TAILA IN COMPARISION WITH EUSOL LIQUID IN THE MANAGEMENT OF DUSHTA VRANA"
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinod Patel |
| Designation |
P.G SCHOLAR IN SHALYA TANTRA |
| Affiliation |
Dr D Y Patil College of Ayurved And Research Centre Pimpri Pune. |
| Address |
opd no. 3 ,ground floor and ipd 2nd floor.
opd no. 3 ,ground floor and ipd 2nd floor.
Pune
MAHARASHTRA
411018
India |
| Phone |
9762341901 |
| Fax |
|
| Email |
vinodp172@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Babar |
| Designation |
HOD AND PROFESSOR |
| Affiliation |
Dr D Y Patil College of Ayurved And Res |
| Address |
opd no. 3 ,ground floor and ipd 2nd floor.
opd no. 3 ,ground floor and ipd 2nd floor.
Pune
MAHARASHTRA
411018
India |
| Phone |
9011035602 |
| Fax |
|
| Email |
sanjaybabar14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinod Patel |
| Designation |
HOD AND PROFESSOR |
| Affiliation |
Dr D Y Patil College of Ayurved And Research Centre Pimpri Pune, Sant Tukaram Nagar. |
| Address |
opd no. 3 ,ground floor and ipd 2nd floor.
opd no. 3 ,ground floor and ipd 2nd floor.
Pune
MAHARASHTRA
411018
India |
| Phone |
9762341901 |
| Fax |
|
| Email |
sanjaybabar14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College of Ayurved And Research Centre Pimpri Pune.Sant Tukaram Nagar 411018. |
|
|
Primary Sponsor
|
| Name |
Vinod Patel |
| Address |
Dr D Y Patil College of Ayurved And Research Centre Pimpri Pune.Sant Tukaram Nagar 411018 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| VINOD PATEL |
Dr D Y Patil College of Ayurved And Research Centre Pimpri Pune.Sant Tukaram Nagar. |
Shaly Tantra OPD Dr D Y Patil College of Ayurved And Research Centre Pimpri Pune.Sant Tukaram Nagar.
Pune
MAHARASHTRA |
9762341901
vinodp172@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:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | EUSOL | in this group 15 patients wound will be washed with normal saline followed by local application of eusol liquid. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: nimbaadi taila, Reference: sushruta samhita, Route: Topical, Dosage Form: Taila, Dose: 3(ml), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: as per ayurveda |
|
|
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Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)Both male and female.
2)Between the age group of 12 to 80 yrs will be included in the study.
3)Patients of dushtavrana with a minimum history of 3 weeks.
4)Dushtavrana size 5x5 (LxL)cms.
5) Selection is irrespective of religion, socio-economical status an occupation.
6) Controlled diabetic patients. |
|
| ExclusionCriteria |
| Details |
1 Patient not willing fortrial
2 Patient who need surgical and other inintervention.
3 Anaemic patient Hb <10 gm
4 Malnourished patient (as per age ,height and weight proportion.)
5 Bleeding disorders (increased B.T and C.T)
6 Patient with septicemia
7 The patients suffering from systemic disease such as AIDS,Tuberculosis,Diabetes mellitus, Hepatitis-B, Malignancy, Vericose ulcer, Deep vein
thrombosis,Arterial ulcer,Neurogenic ulcer, Leprosy, Pregnancy,Leukemia Acute
and Chronic renal failure,Jaundice and cirrhosis of liver, etc..
8 Any congenital diseases or abnormalities. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1-Vrana has been defined as the wound which after healing leaves permanent scar.The word dushta vrana is composed of two different word and two different meanings.
2-To evaluate and establish safer,cost-effective nimbaadi taila in the management of Dushta Vrana |
15 days(1,3,5,7,9,11,13,15 th days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| In this group 15 patients wound will be washed with normal saline followed by local application of eusol liquid. |
15 days (1,3,5,7,9,11,13,15th) with follow up |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
04/12/2021 |
| 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 |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of the study will be to give Ayurvedic treatment to diseased patients to improve his/her condition and we can give his/her cheap,safe side effect free management.The trail will be conducted on 30 patients for follow up 1,3,5,7,9,11,13,15 days and local application on dushta vrana. For 15 patients nimbadi taila will be given for local application for 15 days ,and eusol for another 15 patients for 15 days |