| CTRI Number |
CTRI/2024/12/078528 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
21/12/2024 |
| 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
|
Comparison of the effectiveness of Manjishthasiddha Ghrita and Durvadya Taila for treatment of Vicharchika in children of age group 1-12 years. |
|
Scientific Title of Study
|
A randomised comparative clinical study to evaluate the efficacy of external application of Manjishthasiddha Ghrita and Durvadya Taila in the management of Vicharchika in children of age group 1-12 years. |
| 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 Shreya Sharad Koparde |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurved and Research Centre, Balrog department, Third floor, Nigdi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9922071197 |
| Fax |
|
| Email |
shreyakoparde61@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant M Wankhede |
| Designation |
Assistant Professor |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurved and Research Centre, Balrog department Third floor, Nigdi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9970157701 |
| Fax |
|
| Email |
dr.prash30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashant M Wankhede |
| Designation |
Assistant Professor |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurved and Research Centre, Balrog department Third floor, Nigdi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9970157701 |
| Fax |
|
| Email |
dr.prash30@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre, Nigdi, Pune |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Centre, Nigdi, Pune |
| Address |
PDEAs College of Ayurved and Research Centre, sector 25, Pradhikaran, Nigdi, Pune |
| 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 Shreya Sharad Koparde |
Ayurved Rugnalaya and Sterling Multispeciality hospital Nigdi Pune |
Balrog Department OPD No 118
Pune
MAHARASHTRA |
9922071197
shreyakoparde61@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chairperson Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L08||Infections of the skin and subcutaneous tissue. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Durvadya Taila, Reference: Sahasrayogam Taila prakaran, Route: Topical, Dosage Form: Taila, Dose: 1(NA), Frequency: tds, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 7 Days, Reference: No, Route: NA, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Manjishthasiddha Ghrita, Reference: Bhavprakash Nighantu 190-191, Route: Topical, Dosage Form: Ghrita, Dose: 1(NA), Frequency: tds, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 7 Days, Reference: No, Route: NA, Dosage Form: Ghrita, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient having symptoms of Vicharchika mentioned in ayurvedioc text are- Raaji, Ruja, Kandu, Rukshata. Two or more of these symptoms should be present.
2. Children between the age group of 1 year to 12 years irrespective of sex |
|
| ExclusionCriteria |
| Details |
1.Weeping eczemas, infected lesion will be excluded from the study.
2.Lichenified skin changes.
3.Children having acute febrile illness, acute respiratory infections or any disorders will be excluded from the study. |
|
|
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 study the efficacy pf external application of Manjisthasiddha Ghrita and Durvadya Taila three times a day for 7 days in the treatment of Vicharchika in children of age group 1-12 years. |
7 days treatment with follow up on 7th day with window period of +/- 3 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe adverse effects if any |
7 days treatment with follow up on 7th day |
|
|
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 3 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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
|
According to Ayurveda, skin diseases are discussed under Kushtha. Vicharchika is a type of Kshudra Kushtha. As clinical features of Atopic Dermatitis is similar to that of Vicharchika, they can be correlated. Atopic dermatitis is an in increasing concern in infant and young children as their skin is more sensitive and suceptible to dryness and infection than in adults. The prevalence of atopic dermatitis is estimated to be 15-20%. This is due to increased pollution and urbanization. In Ayurveda, all skin diseases are included in Kushtha roga and many skin diseases like Vicharchika are mentioned there. To normalize the doshas as well as to improve the quality of skin Manjishthasiddha Ghrita has been chosen for the study from Bhavprakash Nighantu. Atopic dermatitis which is caused by genetic predisposition, environmental factors, irritants and allergens is severe not only in terms of appearance but also affects psychological health and sleep patterns of children. There is a need to develop ore effective topical ayurvedic formulations which will upgrade the condition of the patient by normalizing the vitiated doshas and long lasting effect. So this is an attempt to make safe and effective topical medication in treatment of Vicharchika in Children. |