| CTRI Number |
CTRI/2024/03/064692 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Local application of Patoladi Gel in comparision with Zinc Oxide Ointment in Diaper Rash |
|
Scientific Title of Study
|
A Comparative Clinical Study on Patoladi Gel And Standard of Care (Zinc Oxide Ointment) in Management of Ahiputana (Diaper Rash) In Infant |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nasreen |
| Designation |
MD Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
4th floor,Department of Kaumarabhrithya,All India Institute of Ayurveda,Gautam Puri Awas,Sarita Vihar, Delhi
South
DELHI
110076
India |
| Phone |
8383054804 |
| Fax |
|
| Email |
nasreenshekh09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant Kumar Gupta |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
4th floor,Department of Kaumarabhrithya,All India Institute of Ayurveda,Gautam Puri Awas,Sarita Vihar, Delhi
South
DELHI
110076
India |
| Phone |
9990988860 |
| Fax |
|
| Email |
prashantgupta27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nasreen |
| Designation |
MD Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
4th floor,Department of Kaumarabhrithya,All India Institute of Ayurveda,Gautam Puri Awas,Sarita Vihar, Delhi
South
DELHI
110076
India |
| Phone |
8383054804 |
| Fax |
|
| Email |
nasreenshekh09@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda,Gautam Puri Awas,Sarita Vihar, Delhi 110076
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
4th floor,Department of Kaumarabhrithya,All India Institute of Ayurveda,Gautam Puri Awas,Sarita Vihar, Delhi
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nasreen |
All India Institute of Ayurveda,Gautam Puri Awas,Sarita Vihar, Delhi |
OPD 208,All India Institute of Ayurveda,Gautam Puri Awas,Sarita Vihar, Delhi 110076
South
DELHI |
8383054804
nasreenshekh09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Division of Translational Research and Biostatistics All India Institute of Ayurveda |
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Patoladi Gel, Reference: Astang Hridyam, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Zinc Oxide Ointment | Topical application of zinc oxide ointment twice daily for 14 days. |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
1)1 month - 12 months babies using disposable diapers only.
2)Patients of uncomplicated diaper dermatitis.
3)The parent willing to provide written informed consent to participate in the study.
4)ICD -10- CM L22
|
|
| ExclusionCriteria |
| Details |
1)Any type of skin lesion other than the diaper dermatitis.
2)Babies suffering from atopic dermatitis.
3)Babies suffering from systemic illness.
4)Babies on any other treatment for dermatitis.
5)Babies with any Autoimmune disorder.
6)Complicated diaper dermatitis.
7)Any condition which is considered by the investigator to be detrimental to the health of the study participant
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant decrease in Diaper dermatitis scale score (Ahiputana) |
Significant decrease in Diaper dermatitis scale score (Ahiputana)Baseline,1week,2week,follow up after 14 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Efficacy of Patoladi Kwatha against skin inflammatory marker in human skin cell line model.
2)Phytoconstituent analysis of Patoladi Gel.
|
0 day, At 2 week, At 4 week |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
INRODUCTIONDiaper dermatitis is an inflammatory reaction of skin of perineal and perianal areas (Diaper area). It is the most common skin disorder seen in young infants with peak prevalence in 9-12 months of age. Studies report the prevalence varying from 7 to 35 percent. In Ayurveda the clinical feature of diaper dermatitis closely resemble with Ahiputana .Excessive use of diaper during infantile period is one of the main causes in the development of Ahiputana .It is common in both rural and urban setting.It leads to behavioral changes in infant characterized by increased crying and agitation and changes in eating and sleeping patterns.This condition is especially distressing for the growing infant and parents too.The management of diaper dermatitis include conservative management i.e. maintaining hygiene and frequent changing of diapers. Other methods of treatment include use of topical emollients, corticosteroids and antibiotics which often lead to skin damage on prolonged usage. Ayurveda treatment advocated by Acharyas in Ahiputana consist of external application of medicated herbs in paste form. However, application of herbs inpaste form present a challenge in infantile age groups. Till date very few works have been done on Ahiputana,leaving a substantial gap in exploring new form of interventions, which can be easily applied and accepted among infants. Thus, the present study was planned.
OBJECTIVES OF THE RESEARCH PROJECT: Part A : Clinical study Part B : Cell line study The present study has been undertaken with the following objectives:- PRIMARY OBJECTIVES: To Evaluate the efficacy of Patoladi Gel in comparison with Standard of care (Zinc oxide ointment) in the management of Ahiputana (Diaper rash). SECONDARY OBJECTIVES: 1)Efficacy of Patoladi Kwatha against skin inflammatory marker in human skin cell line model. 2)Phytoconstituent analysis of Patoladi Gel.
METHODOLOGY: Sample Size- 60 (30 in Each Group) Group- 2 Intervention- Group A- Zinc oxide ointment, Group B- Patoladi Gel Duration- 14 Days Follow Up - 14 Days
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