| CTRI Number |
CTRI/2024/10/074571 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
27/09/2024 |
| 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
|
Study of the effect of Somraji Taila in Ringworm of Children in comparision to Ketoconazole ointment |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of Somraji Taila in Dadru Kushtha (Dermatophytosis) 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 |
Aishwarya Bhatt |
| Designation |
PG Scholar |
| Affiliation |
Gurukul Campus Uttarakhand Ayurved University, Haridwar |
| Address |
OPD 9 Department Of Kaumarbhritya Gurukul Campus Uttarakhand Ayurved University Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249404
India |
| Phone |
8979533006 |
| Fax |
|
| Email |
chanshinchan2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GP Garg |
| Designation |
Professor and HOD Department of Kaumarbhritya |
| Affiliation |
Gurukul Campus Uttarakhand Ayurved University, Haridwar |
| Address |
OPD 9 Department Of Kaumarbhritya Gurukul Campus Uttarakhand Ayurved University HaridwarUttarakhand
Hardwar
UTTARANCHAL
249404
India |
| Phone |
6395611281 |
| Fax |
|
| Email |
drgarggp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GP Garg |
| Designation |
Professor and HOD Department of Kaumarbhritya |
| Affiliation |
Gurukul Campus Uttarakhand Ayurved University, Haridwar |
| Address |
OPD 9 Department Of Kaumarbhritya Gurukul Campus Uttarakhand Ayurved University HaridwarUttarakhand
Hardwar
UTTARANCHAL
249404
India |
| Phone |
6395611281 |
| Fax |
|
| Email |
drgarggp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttarakhand Ayurveda University Gurukul campus Haridwar Uttarakhand India
Pin code 249404 |
|
|
Primary Sponsor
|
| Name |
Aishwarya Bhatt |
| Address |
OPD No 9 Department of Kaumarbhritya Uttarakhand Ayurveda University Gurukul campus Haridwar |
| 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 Aishwarya Bhatt |
Uttarakhand Ayurved University Gurukul campus Haridwar |
OPD 9 PG Department Of Kaumarbhritya Uttarakhand Ayurved University Gurukul campus Haridwar Uttarakhand
Hardwar
UTTARANCHAL |
8979533006
chanshinchan2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Gurukul Campus UAU Haridwar |
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: DADRU-KUSHTHAH, , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Ketoconazole 2% | Medicine Name: Ketoconazole 2%
Route: Topical
Dose: 5(ml)
Frequency: bd
Dosage Form: Ointment
Duration: 21 Days
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Somraji Taila, Reference: Bhaishajya Ratnavali Shlok number 176 to 180 Kushtharog Chikitsa Adhyaya Page no 657, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 21 Days, Reference: No, Route: NA, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1 Children diagnosed as the case of Dadru Kushta with the presenting symptoms. |
|
| ExclusionCriteria |
| Details |
1 Children below 3 years and above 16 years.
2 Kushtha other than Dadru.
3 Children with known cases of any other systemic disorders like HIV, Leprosy and Dermatitis.
4 Super added infection
5 Known case of Immune deficiency disorders. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Kandu (Itching)
Raga (Erythema)
Utsannata(Elevation of the lesion)
Daaha (Burning sensation)
Visarpata (spread)
Mandala (Diameter and number) |
The assessment of patient will be done at an interval of every 7 days till 21 days during the treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in number and diameter of Mandala(Lesions) |
The assessment of patient will be done at an interval of every 7 days till 21 days during the 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 2 |
|
Date of First Enrollment (India)
|
10/10/2024 |
| 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 study is a Randomised controlled clinical trial to determine the efficacy of Somraji Taila in Dadru (Dermatophytosis) for the age group of 3 to 16 years for 45 days. Study will be conducted at UAU, Gurukul campus, Haridwar on 30 patients. Assessment will be done on the basis of subjective and objectives parameters. Study will be conducted at OPD/IPD level of PG department of Kaumarbhritya. The assignment will be done at interval of 21 days of clinical trial and result obtained will be tabulated and statistically analyzed using appropriate tests. |