| CTRI Number |
CTRI/2018/07/014879 [Registered on: 16/07/2018] Trial Registered Prospectively |
| Last Modified On: |
13/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Management of Dadru (ringworm/tinea) With Ayurvedic Medicine. |
|
Scientific Title of Study
|
A clinical study in the management of dadru kushtha (tinea) with dadruvidravana malhar and khadirashtaka ghanavati |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
vickykumar shambhubhai patel |
| Designation |
PG Scholar |
| Affiliation |
Govt. Akhandanand Ayurved College Ahmadabad |
| Address |
Upgraded dept of Kayachikitsa opd no 9 Govt Akhandanand Ayurved College Bhadra Ahmadabad.
Ahmadabad
GUJARAT
380001
India |
| Phone |
9033756804 |
| Fax |
|
| Email |
dr.vicky90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr dhamini nirmal |
| Designation |
Lecturer |
| Affiliation |
Govt. Akhandanand Ayurved College Ahmadabad |
| Address |
Upgraded dept of Kayachikitsa opd no 9 Govt Akhandanand Ayurved College Bhadra Ahmadabad.
Upgraded dept of Kayachikitsa opd no 9 Govt Akhandanand Ayurved College Bhadra Ahmadabad.
Ahmadabad
GUJARAT
380001
India |
| Phone |
8530445537 |
| Fax |
|
| Email |
drdhamini.dubal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
vickykumar shambhubhai patel |
| Designation |
PG Scholar |
| Affiliation |
Govt. Akhandanand Ayurved College Ahmadabad |
| Address |
Upgraded dept of Kayachikitsa opd no 9 Govt Akhandanand Ayurved College Bhadra Ahmadabad.
Ahmadabad
GUJARAT
380001
India |
| Phone |
9033756804 |
| Fax |
|
| Email |
dr.vicky90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Akhandanand Ayurved College and Hospital ahmedabad |
|
|
Primary Sponsor
|
| Name |
Government Akhandanand Ayurved College and Hospital Ahmedabad and Maniben Ayurved hospital ahmedabad |
| Address |
opd-9 Kayachikitsa dept Government Akhandanand Ayurved College Bhadra Ahmedabad
Gujarat. pin-380001 |
| Type of Sponsor |
Government 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 |
| dr vicky patel |
Government Akhandanand Ayurved College Bhadra Ahmedabad |
opd-9, Kayachikitsa department,Goverment Akhandanand Ayurved College,Ahmadabad
Ahmadabad
GUJARAT |
9033756804
dr.vicky90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patient suffering from dadru, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dadruvidravana malhar |
15 patients will be taken in group A and will be treated with external application Dadruvidravana malhar along with internal medicine of Khadirashtaka ghanavati.
Dadruvidravana malhar -Method of use: External application on affected area
Application time:Morning and Evening
Treatment Duration:4 week
Khadirastak Ghanavati -DOSE: 4 gram in two divided doses /day .{4 tab (500 mg each)×BD}
Anupan: Ushnodak
Duration: 4 week
|
| Comparator Agent |
Khadirashtaka ghanavati |
15 patients will be taken in group B and will be treated with Khadirashtaka ghanavati.
DOSE: 4 gram in two divided doses /day .{4 tab (500 mg each)×BD}
ANUPAN: Ushnodak
DURATION: 4 week
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Duration of disease < 1 year.
2. diameter of lesion should be up to 20 cm approximately.
3. symptoms according to ayurvedic aspect..(kandu , rag, pidaka, udgatmandal )
|
|
| ExclusionCriteria |
| Details |
1. Patient having age Age <18 years and > 60 years should be excluded.
2.Uncontrolled D.M., Cancer, AIDS,STD, T.B., and other disorder which leads fatal condition for patients.
3. Other concomitant skin diseases occurring with Dadru or Dadru occurring as the complication of other diseases or allergic reaction of any other disease.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment will be done clinically on the basis of decrease in complaints of Dadru. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment will be done clinically on the basis of decrease in complaints of Dadru. |
4 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
17/07/2018 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dadru (Tinea) is one of the most common skin disease found in the society. It is a fungal disease caused due to fungus Tinea. Acharya Charaka has included Dadru in Kshudra KushthSelected Drugs for Research Work: Group A : Dadruvidravana Malhar with Khadirashtaka ghanavati. 1 .Dadruvidravana Malhar: Method of use: External application on affected area Application time:Morning and Evening Treatment Duration:4 week 2.Khadirashtaka ghanavati K Dose: 4 gram in two divided doses /day .{4 tab (500 mg each)×BD} Anupan: Ushnodak Duration: 4 week Group B: Khadirashtaka ghanavati: Dose: 4 gram in two divided doses /day .{4 tab (500 mg each)×BD} Anupan: Ushnodak
Duration: 4 week |