| CTRI Number |
CTRI/2019/07/020378 [Registered on: 26/07/2019] Trial Registered Prospectively |
| Last Modified On: |
19/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study to assess the efficacy of khaskhasbeeja beeja and dughda lepa in Darunaka patients |
|
Scientific Title of Study
|
Randomised clinical study to evaluate the efficacy of khaskhasbeeja and dughda lepa in Darunaka according to Sharangdhar samhita |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Suresh Pande |
| Designation |
PG second year student |
| Affiliation |
Dr D Y Patil college of Ayurveda pimpri Pune |
| Address |
Samhita sidhhant department 4 th floor Dr D y patil college of Ayurveda pimpri Pune 411018
Samhita sidhhant department 4 th floor Dr D y patil college of Ayurveda pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8275729869 |
| Fax |
|
| Email |
pandes.pooja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shital rasane |
| Designation |
Associate professor samhita sidhhant department |
| Affiliation |
Dr D y patil college of Ayurveda pimpri Pune |
| Address |
Samhita sidhhant department 4 th floor Dr D y patil college of Ayurveda pimpri Pune
Samhita sidhhant department 4 th floor Dr D y patil college of Ayurveda pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9503330831 |
| Fax |
|
| Email |
shitalrasane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Suresh Pande |
| Designation |
PG second year student |
| Affiliation |
Dr D Y Patil college of Ayurveda pimpri Pune |
| Address |
Samhita sidhhant department 4 th floor Dr D y patil college of Ayurveda pimpri Pune 411018
Samhita sidhhant department 4 th floor Dr D y patil college of Ayurveda pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8275729869 |
| Fax |
|
| Email |
pandes.pooja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D y patil college of Ayurveda pimpri pune |
|
|
Primary Sponsor
|
| Name |
Dr D y patil college of Ayurveda pimpri Pune |
| Address |
Sant Tukaram Nagar Pimpri Pune 411018 |
| 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 |
| Dr Pooja Suresh Pande |
Ground floor opd no 15 Dr D Y Patil college of Ayurveda hospital pimpri Pune |
Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA |
8275729869
pandes.pooja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L210||Seborrhea capitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ketoconazole 2% shampoo |
30 patients will be treated by ketoconazole 2% shampoo twice a week for 1 month |
| Intervention |
Khaskhasbeeja and DUGDHA lepa |
30 patients will be treated by khaskhasbeeja and dughda lepa 15 gms twice a week for 1 month |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patient suffering from darunak |
|
| ExclusionCriteria |
| Details |
Below the age of 20 yrs and 40 yrs
Psoriasis of scalp
Eczema of scalp
Immune compromised condition and systemic infection |
|
|
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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of khaskhasbeeja and dughda lepa in darunak |
Every week after 1st visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of trial drug with ketoconazole 2% shampoo |
Every week after 1st visit |
|
|
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)
|
01/08/2019 |
| 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="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
Prevalence of dandruff is high , which affects 5 % of global population. Recurrence is common. Dealing with dandruff is crucial and embarrassing. Content of lepa is easily available. Hence these topic is selected. |