| CTRI Number |
CTRI/2021/04/032711 [Registered on: 09/04/2021] Trial Registered Prospectively |
| Last Modified On: |
08/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to identify the factors responsible for recurrence of Dadru. |
|
Scientific Title of Study
|
A cross sectional study to identify the factors responsible for recurrence of Dadru. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Ganesh Mahadeo Palhade |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre, Nigdi, Pune 411044 |
| Address |
PDEAs College of Ayurved and Research Centre, Ayurved Samhita and Siddhant Department, Ground floor, Sector no. 25, Pradhikaran, Nigdi
Pune
MAHARASHTRA
411044
India |
| Phone |
9890913566 |
| Fax |
|
| Email |
gp26star@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Yogita Jamdade |
| Designation |
H.O.D. of Ayurved Samhita and Siddhanta department |
| Affiliation |
PDEAs College of Ayurved and Research Centre, Nigdi, Pune 411044 |
| Address |
PDEAs College of Ayurved and Research Centre, Ayurved Samhita and Siddhant Department, Ground floor, Sector no. 25, Pradhikaran, Nigdi
Pune
MAHARASHTRA
411044
India |
| Phone |
9922991376 |
| Fax |
|
| Email |
dryogitaaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Ganesh Mahadeo Palhade |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre, Nigdi, Pune 411044 |
| Address |
PDEAs College of Ayurved and Research Centre, Ayurved Samhita and Siddhant Department, Ground floor, Sector no. 25, Pradhikaran, Nigdi
Pune
MAHARASHTRA
411044
India |
| Phone |
9890913566 |
| Fax |
|
| Email |
gp26star@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre, Nigdi, Pune 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurved and Research Centre, Sector
no-25, Pradhikaran, Nigdi, Pune 411044 |
| 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 |
| Vd Ganesh Mahadeo Palhade |
Ayurved Rugnalay and Sterling Multispeciality Hospital |
Ayurved Rugnalay and
Sterling Multispeciality
Hospital, Room no. 117-B, Ground floor, Pradhikaran, Nigdi, Pune 411044
Pune
MAHARASHTRA |
9890913566
gp26star@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:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Dadru appeared at least 2 times in last one year, irrespective of drugs or procedures taken. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification of the factors responsible for recurrence of Dadru. |
One time only. |
|
|
Secondary Outcome
|
|
|
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)
|
20/04/2021 |
| 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="6"
Days="0" |
|
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)?
Response - NO
|
|
Brief Summary
|
In current medical scenario one can observe increase in patients having skin disorders. Some patients get relief after treatment but some get it again with some time interval or after certain duration of the treatment. Patients undergo ayurvedic or allopathic treatment or sometimes simultaneously medicines from both the pathies. Among them who undergoes only ayurvedic treatment, sometimes they took only shaman treatment or interrupted treatment. Even some patients may apply some home remedies also. Still the scenario is not improving. 39% of world population is suffering from it. In India also, 5 out of 1000 people are suffering from Tinea infections. So identification of factors for recurrent Dadru becomes important for solving this issue. Dadru is co-related with fungal infection. The effect of Dadru seen on patient’s social, psychological, emotional level. It also affects their quality of life. Recurrence of Dadru increases their problems. So it is important to find the root cause responsible for recurrence of Dadru, then one can work on that. That is why the topic is selected for the study. |