| CTRI Number |
CTRI/2024/08/072118 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| 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
|
Effect of raladi lepa in dadru kushta (tinea corporis) |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial to study the effect of Raladi Lepa in Dadru Kushta with special reference to Tinea Corporis in children of age 5-16 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 Sachin Prakash Gwalani |
| Designation |
Assistant professor |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Kaumarbhritya SMBT Ayurved College and Hospital Dhamangaon Nashik
422403
INDIA
Nashik
MAHARASHTRA
444303
India |
| Phone |
9834570287 |
| Fax |
|
| Email |
sachin.gwalani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Sachin Prakash Gwalani |
| Designation |
Assistant professor |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Kaumarbhritya SMBT Ayurved College and Hospital Dhamangaon Nashik
422403
INDIA
Nashik
MAHARASHTRA
444303
India |
| Phone |
9834570287 |
| Fax |
|
| Email |
sachin.gwalani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Sachin Prakash Gwalani |
| Designation |
Assistant professor |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Kaumarbhritya SMBT Ayurved College and Hospital Dhamangaon Nashik
422403
INDIA
Nashik
MAHARASHTRA
444303
India |
| Phone |
9834570287 |
| Fax |
|
| Email |
sachin.gwalani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kaumarbhritya SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Igatpuri Nashik 422403 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Roshan Shrikrushna Sarap |
| Address |
Department of Kaumarbhritya SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Igatpuri Nashik 422403 Maharashtra India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| nil |
nil |
| nil |
nil |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Roshan Shrikrushna Sarap |
SMBT Ayurved college and hospital |
opd no 12 department of kaumarbhritya smbt ayurved college and hospital dhamangaon igatpuri nashik maharashtra-422403
Nashik
MAHARASHTRA |
8425948112
rosh.sarap@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved college and hospital |
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 | Procedure | - | lepa, लेप | (Procedure Reference: Charak Samhita Chikitsa adhaya 7 , Procedure details: Poorva Karma The affected part will be thoroughly washed with lukewarm water & then dried.
Pradhan Karma All the lepa will be prepared for instant & single use. The prepared lepa will be applied on the affected part against the direction pratiloma of hair follicle roots for better absorption. Lepa will be applied twice in a day.
Paschat Karma- lepa will be removed soon after it starts getting adrashushka with the help of clean cotton
)
| | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangdhar Samhita Utarsthan 11 , Procedure details: Poorva Karma The affected part will be thoroughly washed with lukewarm water and then dried.
Pradhan Karma All the lepa will be prepared for instant and single use. The prepared lepa will be applied on the affected part against the direction pratiloma of hair follicle roots for better absorption. Lepa will be applied twice in a day.
Paschat Karma- lepa will be removed soon after it starts getting adrashushka with the help of clean cotton
)
|
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Patient fulfilling the diagnostic criteria with classical sign and symptom of dadru kushta like kandu, mandal and raaga.parents willing to participate of their child and ready to give consent . children between the age group of 5 - 16 years. Patient will be selected irrespective of sex, religion, socioeconomic status. |
|
| ExclusionCriteria |
| Details |
Infected / pus discharging lesion. Patient suffering from chronic or systemic illness. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in signs and symptom of dadru kushta after application of Raladi lepa. |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Where the trial group stands in comparison with control group. |
18 months. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
19/08/2024 |
| 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
|
Dadru is a skin illness having high prevalence
in children of age group 5 -16 years. there is need to find an alternative for
local application as topical steroids commonly used are expensive as well as
they have adverse effects. Raladi lepa seems to be promising
as it has kandughna ( anti-itching) and kushatghna properties.
The cardinal feature of dadru kushta is itching so the use
of raladi lepa can be considered as an option. If research is
conducted to evaluate the effect of raladi lepa in dadru
kushta it will be definitely beneficial.
It will help us to expand our understanding of ancient
remedies and their application in modern time. Valuable insight into the
potential benefits of Raladi lepa in skin condition such
as Dadru can be provided. Patients of age group 5-16
fulfilling clinical diagnostic criteria of Tinea corporis will be selected
irrespective of their sex and socioeconomic status .Written consent from
parents will be obtained for the study. Sample size using Daniel 1999 formula
is 36. These patients will be selected by simple randomisation by lottery
method. Total 72 patients selected will be divided into two groups named as
group A (trial group) and Group B (control group), raladi lepa for
Group A (trial group) and edagajadi lepa for Group B (control
group) . Trial and control group will purchased form GMC certified pharmacy.
Both drugs will be administered in Lepa form for 21 days . All SOP of lepa
vidhi will be strictly followed during and after treatment. Observation
will be done on day 0 , day 7 , day 14 and day 21. Result of the study will
drawn on basis of criteria of assessment and statistical analysis. Discussion
will be done on the basis of observation and result obtained during the
treatment . Summery will be done and whole thesis work will be summarized.
Conclusion will be drawn strictly on the basis of statistical analysis
and will be unbiased.
|