| CTRI Number |
CTRI/2018/10/015879 [Registered on: 03/10/2018] Trial Registered Prospectively |
| Last Modified On: |
06/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effect of Dhatturadi tail and Nilotpladi lepa in the Darunaka |
|
Scientific Title of Study
|
A RANDOMIZED, OPEN LABELLED, COMPARATIVE CLINICAL STUDY ON DHATTURADI TAILA AND NILOTPALADI LEPA IN THE MANAGEMENT OF DARUNAKA W.S.R. TO DANDRUFF." |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gulab Chand Pamnani |
| Designation |
Assistant professor |
| Affiliation |
National institute of Ayurveda |
| Address |
National institute of Ayurveda,jorawar singh gate,amer road ,jaipur
Vijay path ,mansarowar
Jaipur
RAJASTHAN
302002
India |
| Phone |
9461154942 |
| Fax |
|
| Email |
pamnani.gulab@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gulab Chand Pamnani |
| Designation |
Assistant professor |
| Affiliation |
National institute of Ayurveda |
| Address |
National institute of Ayurveda,jorawar singh gate,amer road ,jaipur
Vijay path ,mansarowar
RAJASTHAN
302002
India |
| Phone |
9461154942 |
| Fax |
|
| Email |
pamnani.gulab@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gulab Chand Pamnani |
| Designation |
Assistant professor |
| Affiliation |
National institute of Ayurveda |
| Address |
National institute of Ayurveda,jorawar singh gate,amer road ,jaipur
Vijay path ,mansarowar
RAJASTHAN
302002
India |
| Phone |
9461154942 |
| Fax |
|
| Email |
pamnani.gulab@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF AYURVEDA,JAIPUR |
|
|
Primary Sponsor
|
| Name |
National institute of Ayurveda jaipur |
| Address |
National institute of Ayurveda, jorawar singh gate,amer road , jaipur |
| Type of Sponsor |
Research institution and hospital |
|
|
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 GULAB CHAND PAMNANI |
NATIONAL INSTITUTE OF AYURVEDA,JAIPUR |
NATIONAL INSTITUTE BOF AYURVEDA,JORAWAR SINGH GATE ,JAIPUR
Jaipur
RAJASTHAN |
9461154942
pamnani.gulab@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE .NATIONAL INSTITUTE OF AYURVEDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition:L00-L08||Infections of the skin and subcutaneous tissue. Ayurveda Condition: Suffered From Darunaka, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dhatturadi taila,30ml for 30 days |
Dhattura,leaf and seed,
Tila taula. |
| Intervention |
Nilotpladi lepa, 30gm for 30 days |
Nilakamal,nagkeshar, yathimadhu,amalki,tila churna |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient presenting with classical features of darunaka |
|
| ExclusionCriteria |
| Details |
psoriasis,serious systemic disease ,other kapal gata roga |
|
|
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 treat darunaka |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
kandu
keshchyuti
rukshta
tvak sputana |
one year |
|
|
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 1 |
|
Date of First Enrollment (India)
|
03/10/2018 |
| 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="0"
Months="0"
Days="30" |
|
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
|
"A RANDOMIZED ,OPEN LABELLED,COMPARATIVE CLINICAL STUDY ON DHATTURADI TAILA AND NILOTPALADI LEPA IN THE MANAGMENT OF DARUNAKA W.S.R. TO DANDRUFF."
AIM AND OBJKECTIVES To evaluate the effect of both the trial drugs clinically in the patients of darunaka . To compare the effect of the dhatturadi taila and nilotpaladi lepa . To study the disease darunaka in both Ayurveda and modern parlance.. |