| CTRI Number |
CTRI/2024/01/061622 [Registered on: 19/01/2024] Trial Registered Prospectively |
| Last Modified On: |
15/01/2024 |
| 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
|
To study the efficacy of Tulsi swarasadi Taila and Durvadya Taila in Atopic Dermatitis. |
|
Scientific Title of Study
|
A randomised comparative clinical study to evaluate the efficacy of external application of Tulsi swarasadi Taila and Durvadya Taila in the management of Atopic Dermatitis in Children.( 1 to 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 Aishwarya Dattatraya Kodre |
| Designation |
PG Scholar |
| Affiliation |
PDEAS College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAS College of Ayurved and Research Centre Balrog Department Third floor Nigdi Pune Maharashtra-411044 INDIA
Pune
MAHARASHTRA
411044
India |
| Phone |
8805402754 |
| Fax |
|
| Email |
aishwaryakodre02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudha Singh |
| Designation |
Associate Professor |
| Affiliation |
PDEAS College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAS college of Ayurved and Research centre Balrog Department Third floor Nigdi Pune Maharashtra-411044 INDIA
Pune
MAHARASHTRA
411044
India |
| Phone |
9975404439 |
| Fax |
|
| Email |
drsudha2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudha Singh |
| Designation |
Associate Professor |
| Affiliation |
PDEAS College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAS college of Ayurved and Research centre Balrog Department Third floor Nigdi Pune Maharashtra-411044 INDIA
Pune
MAHARASHTRA
411044
India |
| Phone |
9975404439 |
| Fax |
|
| Email |
drsudha2010@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAS College of Ayurved and Researcg 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 Aishwarya Dattatraya Kodre |
Ayurved Rugnalay and Sterling Multispeciality hospital Nigdi Pradhikaran Pune |
Ayurved Rugnalay And Sterling Multispeciality Hospital Nigdi Pradhikaran Pune Sector 27
Balrog Department OPD No 118 Pune Maharashtra
Pune
MAHARASHTRA |
8805402754
aishwaryakodre02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chairperson Ethics Committee College Of Ayurved and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: TVAGGATAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tulsi swarasadi Taila, Reference: Arogya raksha kalpadrum , Route: Topical, Dosage Form: Taila, Dose: 5(drops), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Durvadya Taila, Reference: Sahastrayogam, Route: Topical, Dosage Form: Taila, Dose: 5(drops), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, 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 atopic dermatitis-Dry skin(Rukshata of twak),Itching(Kandu),Erythema(Raktavarnata of twak) and Eruption(Pidaka)-two or more of these symptoms should be present
2.Children between the age group of 1 to 12 years,irrespective of sex. |
|
| ExclusionCriteria |
| Details |
1.Weeping eczemas,infected lesion will be excluded from the study.
2.Lichenified skin changes.
3.Childern having any other associated illness like diarrhea,acute respiratory infections and acute febrile illness or other disorders will be excluded from the study.
4.Lesions greater than 9% body surface area. |
|
|
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 of external application of Tulsi swarasadi Taila in the management of atopic dermatitis for 15 days in childern (1 to 12 years)for itching. |
15 days where follow up on 7th day,15th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe adverse effects if any in 15 days |
15 days where follow up on 7th day,15th 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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
05/02/2024 |
| 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
|
Human skin is outer protective and largest organ of the body.It constitute first line of defence mechanism.Atopic dermatitis is an acute ,sub-acute,but usually chronic pruritic inflammation of epidermis and dermis .It often has association with personal or family history of asthma and allergic rhinitis.Atopic dermatitis is an increasing concern in infant and young childern as their skin is more sensitive and susceptible to dryness and infection than in adults.Xerosis is hallmark of atopic dermatitis along with itching,exudation,erythema,crusting and scalling of skin.This disease is influencced by defective skin barrier ,immune dysregulation and exaggerated T-cell response to environmental factors and microbes that lead to chronic skin inflammation.The prevalance of atopic dermatitis is estimated to be 15-20% in children and the incidence is increased by 2-3 folds.Considering the sign and symptom of atopic dermatitis, in ayurveda vata-pitta dosha seems to be associated .To normaised the dosha as well as to improve the quality of skin ,Tulsi Swarasadi Taila has been chosen for the study. |