| CTRI Number |
CTRI/2021/06/034101 [Registered on: 09/06/2021] Trial Registered Prospectively |
| Last Modified On: |
08/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO STUDY THE EFFECT OF SHIRISHTWAK LEPA IN DADRU KUSHTHA ESPECIALLY TINEA INFECTION |
|
Scientific Title of Study
|
A RANDOMISED OPEN CONTROLLED CLINICAL STUDY TO EVALUATE EFFICACY OF CHARAKOKTA SHIRISHTWAK LEPA IN DADRU KUSHTHA WITH SPECIAL REFERENCE TO TINEA INFECTION
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Snehal Sambhaji Patil |
| Designation |
PG Scholar |
| Affiliation |
Yashavant Ayurved Mahavidyalaya, Kodoli, Kolhapur |
| Address |
Vd.Snehal Patil,Department of Ayurved Samhita Evam Siddhant,Yashavant Ayurved Mahavidyalaya and PGTRC,Kodoli
Tal Panhala
Dost Kolhapur
Maharashtra 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7741971387 |
| Fax |
|
| Email |
snehalpatil9596@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Sanjay G Kulkarni |
| Designation |
Professor and HOD, Department of Ayurved Samhita Evam Siddhant |
| Affiliation |
Yashavant Ayurved Mahavidyalaya,Kodoli, Kolhapur |
| Address |
Vd.Sanjay Kulkarni,Department of Ayurved Samhita Evam Siddhant,Yashavant Ayurved Mahavidyalaya and PGTRC,Kodoli
Tal Panhala
Dost Kolhapur
Maharashtra 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8788058895 |
| Fax |
|
| Email |
sanjaygk50@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Sanjay G Kulkarni |
| Designation |
Professor and HOD, Department of Ayurved Samhita Evam Siddhant |
| Affiliation |
Yashavant Ayurved Mahavidyalaya,Kodoli, Kolhapur |
| Address |
Vd.Sanjay Kulkarni,Department of Ayurved Samhita Evam Siddhant,Yashavant Ayurved Mahavidyalaya and PGTRC,Kodoli
Tal Panhala
Dost Kolhapur
Maharashtra 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8788058895 |
| Fax |
|
| Email |
sanjaygk50@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashavant Ayurved Mahavidyalaya,Kodoli, Kolhapur |
|
|
Primary Sponsor
|
| Name |
Yashavant Ayurved MahavidyalayaKodoli Kolhapur |
| Address |
Yashavant Ayurved Mahavidyalaya,Kodoli
Tal Panhala
Dist Kolhapur
416114 |
| Type of Sponsor |
Private medical college |
|
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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 Snehal S Patil |
Yashavant Ayurved Mahavidyalaya,Kodoli,Kolhapur |
OPD no 17,Kayachikitsa OPD,
Yashavant Ayurved Mahavidyalaya,
Kodoli Tal Panhala
Dist Kolhapur
416114
Kolhapur
MAHARASHTRA |
7741971387
snehalpatil9596@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMITTEE |
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:L00-L08||Infections of the skin and subcutaneous tissue. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Itraconazole 1% ointment |
Group B Itraconazole 1% ointment is applied on skin according to size and shape of lesion for 30 min twice a day for 30 days and follows up after every 10,20 and 30 days |
| Intervention |
SHIRISHTWAK LEPA |
Group A SHIRISHTWAK LEPA is applied on skin according to size and shape of lesion
Wait till it dries and then remove generally for 30 days and follows up after 10,20 and 30 days
Apply twice a day |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with signs and symptoms of DADRU KUSHTHA
(Raga,mandalotpatti,rukshata,pitikotpatti etc) |
|
| ExclusionCriteria |
| Details |
Tinea more than 2 yrs
Tinea associated with other skin diseases
Skin disorder associated with chronic systemic diseases |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe and document the effect of SHIRISHTWAK LEPA in DADRU KUSHTHA |
Assessment after 10,20 and 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To observe and document the comparative effect of SHIRISHTWAK LEPA and Itraconazole 1% ointment in DADRU KUSHTHA
2. To find out side effects of SHIRISHTWAK lepa |
Assessment after 10,20 and 30 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
18/06/2021 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
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Brief Summary
|
The current study is open randomised controlled clinical trial, comparing the effect of SHIRISHTWAK lep twice a day and local application of Itraconazole 1% ointment twice a day in DADRU KUSHTHA .The seperate pathyapathya sheets will be advised to the patients of both groups. After treatment period patient will be observed for next 1 month. SHIRISHTWAK LEPA is mentioned in Charak Samhita Chikitsa sthan KUSHTHA chikitsa adhyay. It is easy to available and to use. SHIRISHTWAK is vishaghna, kashay rasapradhan, vranya dravya which helps to releave skin diseases. |