| CTRI Number |
CTRI/2025/04/085361 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| 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 efficacy of tuvarakadi cream in the managment of eczema in children |
|
Scientific Title of Study
|
A clinical study to assess the efficacy of tuvarakadi cream in the managment of charmadala in the age group of 6 months to 2 year childrem with special reference to atopic dermatitis |
| 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 Rashmi Janbandhu Meshram |
| Designation |
MD scholar Kaumarbhritya |
| Affiliation |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi
Hadapsar Pune OPD NO 13 Department of Kaumarbritya Sane
Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India
Pune
MAHARASHTRA
411028
India |
| Phone |
|
| Fax |
|
| Email |
rashmimeshram99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramchandra Pandurang Babar |
| Designation |
Professor of department of Kaumarbritya |
| Affiliation |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi
Hadapsar Pune OPD NO 13 Department of Kaumarbritya Sane
Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India
Pune
MAHARASHTRA
411028
India |
| Phone |
8275459236 |
| Fax |
|
| Email |
ramchandrababar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramchandra Pandurang Babar |
| Designation |
Professor of department of Kaumarbritya |
| Affiliation |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi
Hadapsar Pune OPD NO 13 Department of Kaumarbritya Sane
Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India
Pune
MAHARASHTRA
411028
India |
| Phone |
8275459236 |
| Fax |
|
| Email |
ramchandrababar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kaumarbhritya Sane guruji Arogya Kendra Malwadi Hadapsar Pune 411028 |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rashmi Meshram |
Sane guruji arogya kendra |
OPD NO 13
Department of
Kaumarbritya
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
0983 402 9188
rashmimeshram99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MAM S Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: CARMADALA-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tuvarakadi cream, Reference: Bhaishajratnavali Kushtavairibhav taila Kushtarogadhikar Shloka no 67, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: 2 mg per square cm of affected area of skin Dwikale Snanoparant |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
Patient having classical signs and symptoms of Vataj Charmadala.
Infants and toddlers between the Age group 6 months to 2 years.
Patients irrespective of sex, religion and socioeconomical status.
Patient of the parent who will give written consent will be included. |
|
| ExclusionCriteria |
| Details |
Charmadala associated with sphota.
Patient with associated skin infections such as herpes simplex,
herpes zoster, scabies, impetigo or lichen simplex chronicus and
congenital syphilis.
Children having any other associated illness such as acute
exacerbation of asthma or hey fever.
Children admitted in NICU and PICU.
Children receiving phototherapy.
Patient with more than 60 % body surface involvement.
Patient taking treatment from any other pathy for the same
problem. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate efficacy of Tuvarakadi cream in the management of charmadala
in the age group of 6 months to 2 year old children in time span of 14 days |
Treatment will be given for 14 days
Tuvarakadi will be given to the patient for external application.
Follow up and assessment will be done after7th day and 14th day.
Final observation will be recorded after
completion of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe adverse effect & evaluate the safety of Tuvarakadi cream in the management of charmadala in
the age group of 6 months to 2 year old children in the time span of 14 days |
Study will be done using Ayurvedic Granthas &
modern texts
Preparation of drugs will be done according to
standard procedure
During treatment observation will be done on 7th day & 14th day. Later adverse effect will be studied
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
04/05/2025 |
| 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="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
|
This is a clinical study to assess the efficacy of tuvrakadi cream in the management of charmadala in the age group of 6 months to 2 year children with special reference to atopic dermatitis Primary objective is to study the effectiveness of tuvarakadi cream as bahirparimarjana in the management of charmadala in kshreerap and kshreeranada balak in the timespan of 14 days. Assessment of signs and symptoms will be done and observation will be drawn from the outcome of patient. |