| CTRI Number |
CTRI/2019/08/020628 [Registered on: 08/08/2019] Trial Registered Prospectively |
| Last Modified On: |
08/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Khadirashtaka Kwatha and Chakramardabijadi Pralepa in Dadar |
|
Scientific Title of Study
|
A clinical study on Dadru Kushtha (Tinea) and its management by Khadirashtaka Kwatha with and without Chakramardabijadi Pralepa |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Drashty D Kambad |
| Designation |
PG Scholar |
| Affiliation |
Govt Akhandanand Ayurved College |
| Address |
Room No 9 Kayachikitsa Department Govt Akhandanand Ayurved College Bhadra Ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
9712568147 |
| Fax |
|
| Email |
drdrashtykambad615@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surendra Soni |
| Designation |
HOD Kayachikitsa Department |
| Affiliation |
Govt Akhandanand Ayurved College |
| Address |
Room no 9 Kayachikitsa Department Govt Akhandanand Ayurved College Bhadra Ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
9408441150 |
| Fax |
|
| Email |
surendraasoni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Drashty D Kambad |
| Designation |
PG Scholar |
| Affiliation |
Govt Akhandanand Ayurved College |
| Address |
Room No 9 Kayachikitsa Department Govt Akhandanand Ayurved College Bhadra Ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
9712568147 |
| Fax |
|
| Email |
drdrashtykambad615@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Govt Akhandanand Ayurved College |
| Address |
Govt Akhandanand Ayurved College Bhadra Ahmedabad |
| 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 |
| Drashty Kambad |
Govt Akhandanand Ayurved College |
Room No 9 Kayachikitsa Department Govt Akhandanand Ayurved College Bhadra Ahmedabad
Ahmadabad
GUJARAT |
9712568147
drdrashtykambad615@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: B359||Dermatophytosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Khadirashtaka Kwatha |
Khadirashtaka Kwatha will be prepared as Described In Sharangdhar samhita madhyama khanda dose 80 ml per day divided in to two doses per day |
| Intervention |
Khadirashtaka kwatha With Chakramardabijadi pralepa |
Khadirashtaka Kwatha and Chakramardabijadi pralepa will be prepared as described in Sharangdhara Samhita Madhyama khanda
Kwatha Dose 80 ML in two divided doses per day (40 ML×BD) Pralepa Dose 20 gm per day for 4 weeks Administration Local Application on affected area Single sitting duration lepa will be removed after it becomes 70% dry
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Duration of Disease is less than one year
Diameter of lesion should be up to 10 cm approximately
Patient having maximum 4 symptoms od Daddy kushtha (Tinea) will be included (kamu raga pipila udhar mandala)
|
|
| ExclusionCriteria |
| Details |
Age less than 18 years and more than 60 years
Uncontrolled DM Cancer AIDS STD TB and other disorder which leads to fatalcondition for patient
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
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Result will be assessed on the Basis of Sign and Symptoms Of Dadru Kushtha (Tinea) |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
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)
|
19/08/2019 |
| 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
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To study the efficacy of khadirashtaka kwatha and chakramardabijadi pralepa in the management of Dadru kushtha (Tinea ) This study is Randomized controlled Open Label Parellal Group Trial
|