| CTRI Number |
CTRI/2024/07/071569 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of ayurvedic aushadhi in the treatment of Diaper rash |
|
Scientific Title of Study
|
Single arm clinical study of asanatwak malahara in the management of ahiputana with special reference to diaper 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 Dhanashree Mali |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic hospital,Kaumarbhritya Department,OPD No.2 Urun Islampur |
| Address |
LRP Ayurvedic medical college and hospital, PG Institute and Research center,Kaumarbhritya Department,OPD No.2 Urun Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
9921286060 |
| Fax |
|
| Email |
drdhanashreemali01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyotsna Ahir |
| Designation |
Associate professor |
| Affiliation |
LRP Ayurvedic hospital,Kaumarbhritya Department,OPD No.2 Urun Islampur |
| Address |
LRP Ayurvedic medical college and hospital, PG Institute and Research center,Kaumarbhritya Department,OPD No.2 Urun Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
7276538181 |
| Fax |
|
| Email |
drjyotsnaahir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhanashree Mali |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic hospital,Kaumarbhritya Department,OPD No.2 Urun Islampur |
| Address |
LRP Ayurvedic medical college and hospital, PG Institute and Research center,Kaumarbhritya Department,OPD No.2 Urun Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
9921286060 |
| Fax |
|
| Email |
drdhanashreemali01@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic medical college and hospital, PG Institute and Research center 415409 |
|
|
Primary Sponsor
|
| Name |
Dr Dhanashree Mali |
| Address |
LRP Ayurvedic medical college and hospital, PG Institute and Research center 415409 |
| 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 |
| Dr Dhanashree Mali |
LRP Ayurvedic hospital ,Kaumarbhritya department,OPD No.2Urun Islampur |
LRP Ayurvedic college and hospital,PG institute and Reasearch center,Kaumarbhritya Department,OPD No.2,Room No 2,Urun Islampur
Sangli
MAHARASHTRA |
9921286060
drdhanashreemali01@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: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: Asantwak Malahara, Reference: Vagbhat Uttartantra Balamaypratishedh 2/74, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 20(g), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: Local Application |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
3.00 Year(s) |
| Gender |
Both |
| Details |
1. Children will be diagnosed as the case of Ahiputana/Diaper Rash with
presenting symptoms like Kandu, Ruja, Raga, Strava Pidika.
2. H/O symptoms of Ahiputana/ Diaper rash not more than 10 days.
3. Children in between the age group 6 month to 3 Years, irrespective of
sex, religion, socio- economic status and food habits.
4. Parent will be willing to give written consent |
|
| ExclusionCriteria |
| Details |
1. Patient suffering from any systemic disease e.g.Acute gastro
enteritis, Bacillary dysentery, Helminthic infection,secondary infection
etc will be excluded
2. Patient with other generalized skin infection other than Ahiputana
will be excluded |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To decrease the symptoms of diaper rash |
10 days study with follow up of 3rd,5th and 10th day (0,3,5,10) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Ayurvedic formulations |
10 days study with follow up of 3rd,5th and 10th day (0,3,5,10) |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
07/10/2024 |
| 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
|
This is a single arm clinical study of Asantwak Malahara in the management of Ahiputana (Diaper Rash). Ahiputana is a pitta-kapha predominant disorder mentined in ayurvedic samhitas. It shows symptoms like itching i.e kandu in anal region which leads to vranas. Diaper rash is similar clinical condition described in modern science which caused due to unhygienic condition and use of diaper. The word rash means an out break of red bumbs on the body.The prevalence in infants has been estimated to be 7% to 35%. In Ayurved samhita and modern science many drugs are mentioned for internal use and for external application for Ahiputana.Ahiputana is pittakapha rakta predominant disease so acharyas indicated pittakaphahar and raktashodhana chikista.For that in samhitas described many lepas,malahara and awachurnan dhawan chikista. So according to Ashtang Hrudaya Uttarsthan 2nd adhyaya Asantwak is indicated for Ahiputana. |