| CTRI Number |
CTRI/2025/06/089533 [Registered on: 25/06/2025] Trial Registered Prospectively |
| Last Modified On: |
21/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A COMPARATIVE CLINICAL STUDY ON RASANJAN LEPA AND SHVETA
MALAHARA OINTMENT IN THE MANAGEMENT OF AHIPUTANA WITH
SPECIAL REFERENCE TO NAPKIN RASH IN CHILDREN IN AGE GROUP 1 MONTH TO 24 MONTH. |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY ON RASANJAN LEPA AND SHVETA
MALAHARA OINTMENT IN THE MANAGEMENT OF AHIPUTANA 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 Abhishek Harinarayan Pandhare |
| Designation |
PG Scholor |
| Affiliation |
Ashvin rural ayurved college , manchi hill. |
| Address |
Ashvin rural ayurved college , manchi hill, ashwi budruk, tq- sangamner , dist - ahmadnagar.
Ashvin rural ayurved college and hospital manchi hill, ashwi bk, tq- sangamner , dist - ahmadnagar.
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9143426111 |
| Fax |
|
| Email |
abhishekpandhare99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anhishek Harinarayan Pandhare |
| Designation |
PG Scholor |
| Affiliation |
Ashvin rural ayurved college , manchi hill. |
| Address |
Ashvin rural ayurved college , manchi hill, ashwi bk, tq- sangamner , dist - ahmednagar.
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9143426111 |
| Fax |
|
| Email |
abhishekpandhare99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anhishek Harinarayan Pandhare |
| Designation |
PG Scholor |
| Affiliation |
Ashvin rural ayurved college , manchi hill. |
| Address |
Ashvin rural ayurved college , manchi hill, ashwi bk, tq- sangamner , dist - ahmednagar.
Ashvin rural ayurved hospital , manchi hill, ashwi bk, tq- sangamner , dist - ahmednagar.
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9143426111 |
| Fax |
|
| Email |
abhishekpandhare99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ashvin rural ayurved college and hospital manchi hill, ashwi bk, tq- sangamner , dist - ahmadnagar. |
|
|
Primary Sponsor
|
| Name |
Ashvin rural ayurved college manchi hill ashwi bk |
| Address |
Ashvin rural ayurved college , manchi hill, ashwi bk, tq- sangamner , dist - ahmednagar.
413714 maharastra india |
| 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 |
| Dr Anhishek Harinarayan Pandhare |
Ashvin rural ayurved college and hospital |
Ashvin rural ayurved college and hospital balrog opd , kaumarbhritya department , manchi hill, ashwi bk, tq- sangamner , dist - ahmednagar
Ahmadnagar
MAHARASHTRA |
09143426111
abhishekpandhare99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chairperson institutional ethical comitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: AHIPUTANA/AHIPUTANAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: shveta malahara, Reference: classical textbooks, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: sos, Bhaishajya Kal: Antarabhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -local application | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: rasanjan lepa, Reference: classical textbooks, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: sos, Bhaishajya Kal: Antarabhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -local application |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
24.00 Month(s) |
| Gender |
Both |
| Details |
Children having symptoms of Ahiputana like Vrana,
Strava, kandu, Pidika.Children of either Gender, irrespective of socioeconomic
status.Age between 1 months to 24 months.
Parent willing to sign the informed consent form |
|
| ExclusionCriteria |
| Details |
Children suffering from any systemic disorder Ex. Acute gastro-enteritis, Enteritis with Dehydration, Helminthic infection, Lactogenic intolerance, Secondary infection, etc.Age less than 1 month and more than 24 months.Children who have other generalized skin infection other
than Ahiputana / Napkin Rash.Any other skin diseases like Atopic dermatitis, etc. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effect as relif in symptomes of Rasanjan Lepa and Shveta Malahara
ointment effective in the management of Ahiputana with special
reference to Napkin Rash in Children after 7 days. |
To compare the effect of Rasanjan Lepa and Shveta Malahara
ointment effective in the management of Ahiputana with special
reference to Napkin Rash in Children. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe adverse effect if any. |
Follow up on 0th, 3rd, 5th, 7th day of treatment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
10/07/2025 |
| 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
|
In Ayurveda there is description of eight basic principles which
are known asa ‘Ashtanga Ayurveda’2. Kaumarbhritya also called ‘Bala
Chikitsa’ or ‘Balaroga’ is one of the branch and important
specialization in Ayurveda. In which various diseases and its
management are described according to Ayurveda.
The disease Ahiputana correlated with the ‘Napkin Rash’ or
‘Diaper Rash’ in modern science. Ahiputana is mentioned in Kshudra
Roga in all Samhita3.
Napkin rashes are ubiquitous problem present in the pediatric
practice. It is also known as ‘Diaper dermatitis’. This condition is also
referred as Ahiputana, Gudakuttaka, Mathrukadosha, Prishtaru and
Anamaka in Ayurveda Samhitas. It is developed by improper care of
infants and children requiring diapering and is also said to be caused
by Stanyadushti (vitiated breast milk).
The disease is characterized by erythema, papules, pustules,
ulcer, erosions, etc. in the anal region. This condition has close
resemblance with the diaper dermatitis which encompasses irritant
contact diaper dermatitis, candidial diaper dermatitis, perianal
infectious dermatitis, etc. and is comorbid with Atisara Grahani
Rogas, Putana Graha, Ksheeralasaka, Charmadala, etc. |