| CTRI Number |
CTRI/2021/05/033839 [Registered on: 27/05/2021] Trial Registered Prospectively |
| Last Modified On: |
25/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to Study the effect of Badaritwakadi Lepa on napkin rash |
|
Scientific Title of Study
|
Open randomized control clinical study of efficacy of Badaritwakadi Lepa on Ahiputana with special reference Napkin Rash |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Pravin Mohite Patil |
| Designation |
PG Scholar kaumaryabritya |
| Affiliation |
Hon.Shri Annasaheb Dange ayurvedic Medical College and Research center Ashta Sangli |
| Address |
Department of kaumaryabritya Hon.Shri Annasaheb Dange ayurvedic Medical College and Research center Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
9892986873 |
| Fax |
|
| Email |
priyankajadhav91417@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nareshkumar Babar |
| Designation |
Reader |
| Affiliation |
Hon.Shri Annasaheb Dange ayurvedic Medical College and Research center Ashta Sangli |
| Address |
Department of kaumaryabritya Hon.Shri Annasaheb Dange ayurvedic Medical College and Research center Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
7507595454 |
| Fax |
|
| Email |
dr.nareshbabar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Pravin Mohite Patil |
| Designation |
PG Scholar kaumaryabritya |
| Affiliation |
Hon.Shri Annasaheb Dange ayurvedic Medical College and Research center Ashta Sangli |
| Address |
Department of kaumaryabritya Hon.Shri Annasaheb Dange ayurvedic Medical College and Research center Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
9892986873 |
| Fax |
|
| Email |
priyankajadhav91417@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon.Shri Annasaheb Dange ayurvedic Medical College and Research center Ashta
|
|
|
Primary Sponsor
|
| Name |
HonShri Annasaheb Dange ayurvedic Medical College and Research center Ashta |
| Address |
Hon.Shri Annasaheb Dange ayurvedic Medical College and Research center Ashta
|
| 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 |
| Priyanka Pravin Mohite Patil |
Dhanvantari Hospital Ashta |
Department of kaumaryabritya Hon.Shri Annasaheb Dange ayurvedic Medical College and Research center Ashta
Sangli
MAHARASHTRA |
9892986873
priyankajadhav91417@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:L22||Diaper dermatitis. Ayurveda Condition: AHIPUTANA/AHIPUTANAKAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Badritwakadi lepa |
Badaritwakadi Lepa
Dose as per local application
Frequency 2 time per day for 5day for External Application |
| Comparator Agent |
Bal bhaishjyadi Lepa |
Bal bhaishjyadi
Dose as per local application
Frequency 2 time per day for 5day for External Application |
|
|
Inclusion Criteria
|
| Age From |
4.00 Month(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
1.Children diagnosed as case of Ahiputana with the presenting symptom like Kandu,Ruja,Daha,Pidika at Guda Pradesh
2.children inbetween age of 4 month to 2year |
|
| ExclusionCriteria |
| Details |
1.Children above the 2 year and below 4 month
2.children suffering from any other sever systemic disorder e. g acute gastroenteritis with dehydration / heminthes infection
3.childern in NICU AND PICU
4. lactose intolerant |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of badaritwakadi Lepa in Ahiputana |
5 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To review literature of ahiputana |
4 week |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/06/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The clinical features of napkin rash resemble with Ahiputana the skin problems motioned in Ayurvedic literature with pitta and Kalpha dosha dusti Prevalence rate of Ahiputana is 7-35% Ahiputana explained under kshrudraroga / in ahiputana there is redness of skin, skin irritation,outbreak redbumps In modern science Ahiputana can be correlate with napkin rash also called diaper dermatitis,Skin disease not cure only internal medicine but also requires External application ,such as badaritwakadi lepa and bal bhaishajya lepa which reduce symptoms localy hence the topic is chosen |