| CTRI Number |
CTRI/2021/03/031869 [Registered on: 10/03/2021] Trial Registered Prospectively |
| Last Modified On: |
14/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management of Napkin rashes |
|
Scientific Title of Study
|
Evaluatation of the efficacy of kailas jeevan in the managemnt of diaper dermatitis in children -an open clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Azizahmed Arbar |
| Designation |
Professor |
| Affiliation |
KAHER KLE SBMK Ayurveda Mahavidyalaya |
| Address |
No 64 CTS no 842 RS No 47 Behind Rehamania Masjid Arbar Clinic Shahu Nagar
KAHER KLE SBMK Ayurveda MahavidyalayaShahapur Belagavi 590003
Belgaum
KARNATAKA
590010
India |
| Phone |
9844532113 |
| Fax |
|
| Email |
azizarbar.kaher@kleayurworld.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Azizahmed Arbar |
| Designation |
Professor |
| Affiliation |
KAHER KLE SBMK Ayurveda Mahavidyalaya |
| Address |
No 64 CTS no 842 RS No 47 Behind Rehamania Masjid Arbar Clinic Shahu Nagar
KAHER KLE SBMK Ayurveda MahavidyalayaShahapur Belagavi 590003
Belgaum
KARNATAKA
590010
India |
| Phone |
9844532113 |
| Fax |
|
| Email |
azizarbar.kaher@kleayurworld.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Azizahmed Arbar |
| Designation |
Professor |
| Affiliation |
KAHER KLE SBMK Ayurveda Mahavidyalaya |
| Address |
No 64 CTS no 842 RS No 47 Behind Rehamania Masjid Arbar Clinic Shahu Nagar
KAHER KLE SBMK Ayurveda MahavidyalayaShahapur Belagavi 590003
Belgaum
KARNATAKA
590010
India |
| Phone |
9844532113 |
| Fax |
|
| Email |
azizarbar.kaher@kleayurworld.edu.in |
|
|
Source of Monetary or Material Support
|
| Kailas Jeevan manufacturers |
|
|
Primary Sponsor
|
| Name |
Kailas Jeevan manufacturers |
| Address |
Dhayari Dhayari Phata Rd Benkar Vasti Dhayari Phata Pune Maharashtra 411041 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Azizahmed Arbar |
KAHER KLE Shri BMK Ayurveda Mahavidyalaya |
KAHER KLE Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA |
9844532113
azizarbar.kaher@kleayurworld.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, KLE Shri BMK Ayurveda Mahavidyalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L22||Diaper dermatitis. Ayurveda Condition: GUDAPAKAH/GUDAKUTTANAM, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kailash Jeevan ointment will be applied externally |
On the diagnosed cases of diaper Dermatitis KAilash jeevan will be applied externally for a period of 10 days or untill recovery which ever may be earlier |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
36.00 Month(s) |
| Gender |
Both |
| Details |
Neonates, Infants and Toddlers from birth to 3 years suffering from signs and symptoms of Diaper Dermatitis. |
|
| ExclusionCriteria |
| Details |
Children under the medication for systemic and topical diseases.
Children with with severe infective Diaper Dermatitis needing emergency medications
Children with acute or chronic illnesses that necessitates exclusion will be excluded
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| At the end of the treatment period the subjects will have improvement in signs and symptoms of Diaper dermatitis |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There will be no intended secondary outcome |
18 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/03/2021 |
| Date of Study Completion (India) |
02/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
02/02/2022 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diaper dermatitis (DD) is one of the most common skin conditions that infants suffer from and their caregivers manage in the first months post-birth. Diaper dermatitis can be seen mentioned in Ayurveda as Ahipootana is caused by frequent stagnated urine, faeces and sweat around the anal region for longer duration, resulting into spota with kandu around the anal region. Similar condition can be seen in diarrhoea with anal excoriation and even in diaper dermatitis. If it is ignored, lead to wide spread infection by bacteria or fungi necessitating vigorous and prolonged treatment.[1,2,3] Ahiputan in Ayurveda is said to be darunand ghora.[1,2] Clinical condition like diarrhoea can increase the incidence rate of NAPKIN RASH in babies.[2] The prevalence of diaper dermatitis has been reported from 4-35% in the 1st two years of life and in India it is 13%.[4] The infants skin cannot withstand the toxicity of most substances like urine and faeces as they make skin delicate[5] and skin is a potential portal of entry for invasive infective organisms in neonates and infants. Skin break down is very common during infancy period which will enhance the condition like anal excoriation and diaper dermatitis.[6,7] The usage of Kailas Jeevan which is a protective liniment used in variety of skin conditions especially those that have burning sensation exfoliation, cracked skin etc is time proven as the medicament is in market since last 60 years[8] But there are no known clinical research works as on date and also there is a need for an effective medication in Napkin rash. So there is need to study on Diaper dermatitis with Kailas Jeevan. . |