| CTRI Number |
CTRI/2024/08/072058 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Arjunadi lepa in Napkin rash |
|
Scientific Title of Study
|
A randomised controlled clinical trial to study the effect of Arjunadi lepa in Ahiputna with special reference to napkin rash in children. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Poonam Abaso Khaladkar |
| Designation |
PG Student |
| Affiliation |
SMBT Ayurved college and hospital |
| Address |
OPD no 12 Department of Kaumarbhritya SMBT ayurved College Dhamangaon Igatpuri Nashik
SMBT Ayurved college and hospital Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
8857089042 |
| Fax |
|
| Email |
poonamkhl20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Suryawanshi |
| Designation |
Professor |
| Affiliation |
SMBT Ayurved college and hospital |
| Address |
Department of Kaumarbhritya SMBT Ayurved college and hospital Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
9420373110 |
| Fax |
|
| Email |
suvisa65@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Suryawanshi |
| Designation |
Professor |
| Affiliation |
SMBT Ayurved college and hospital |
| Address |
Department of Kaumarbhritya SMBT Ayurved college and hospital Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
9420373110 |
| Fax |
|
| Email |
suvisa65@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kaumarbhritya SMBT ayurved College and hospital Dhamangaon Igatpuri
Nashik Maharashtra 422403 |
|
|
Primary Sponsor
|
| Name |
Poonam Abaso Khaladkar |
| Address |
SMBT Ayurved college and hospital Dhamangaon Igatpuri Nashik 422403 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrPoonam Abaso Khaladkar |
SMBT ayurved College and hospital |
OPD no.12 Department of Kaumarbhritya SMBT ayurved College and hospital Dhamangaon Igatpuri Nashik 422403
Nashik
MAHARASHTRA |
8857089042
poonamkhl20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved college and hospital Dhamangaon |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Triphaladi raskriya , Reference: Dravyaguna vignyan yadavji trikamji, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Arjunadi lepa , Reference: Harit Samhita , Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
Patient of age group 1 month to 2 years
Patient suffering from sign and symptom of
Ahiputna
Selection of patient wil be performed irrespective of sex socio economic status and community
Parent willing to give written consent |
|
| ExclusionCriteria |
| Details |
Children above the age group of 2 years and below 1 month
Children suffering from any other systemic disorder dehydration acute gastrointeritis secondary infection
Children who have other generalized skin infection |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the diaper rash assessment scale |
Reduction in symptoms of diaper rash after 7 days of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Where the trial group stands in comparison with the control group |
18 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 |
|
Date of First Enrollment (India)
|
19/08/2024 |
| 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="6"
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
|
Napkin rash or diaper dermatitis of thigh and buttocks results from exposure to urine and faeces in infant diapers.In initial years of life children are more prone to diseases emerging due to unhygienic conditions as upto this age child has not developed full control over bladder and bowel .Ahiputna can be correlated with Diaper rash where kapha and rakta dushti occurs.It’s prevalance is about 7-35%. Arjunadi lepa selected for the study is having antibacterial pitta kaphaghna vranropak properties so can be very useful in treating Ahiputna. Children of age group group 1 month to 2 years will be selected for the study irrespective of sex socioeconomic status and fulfilling inclusion criteria.Sample size using formula by Daniel 1999 the calculated sample size is 90. For this study it. is divided into two. groups each containing 45 patients.Simple random sampling technique will be used.Group A (Trial group) and group B (control group) each containing 45 patients Group A will be given Arjunadi lepa and Group B will be given Triphaladi Raskriya.Both drugs will be purchased from GMC certified pharmacy. Both drugs will be administered in lepa form for 7 days.All SOP of lepa vidhi will be strictly followed during the treatment observation will be done on day 0 day 3 and day 7. Null Hypothesis (H0): Arjunadi lepa is not effective in the treatment of Ahiputna between the age group of 1 month to 2 years . Alternative Hypothesis (H1): Arjunadi lepa is effective in the treatment of Ahiputna between the age group of 1 month to 2 years |