| CTRI Number |
CTRI/2024/03/064763 [Registered on: 26/03/2024] Trial Registered Prospectively |
| Last Modified On: |
15/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management of Dadru with Kusthadi Lepa and Khadirasthaka Ghanavati. |
|
Scientific Title of Study
|
Efficacy of Kusthadi Lepa and Khadirasthaka Ghanavati in the
management of Dadru w.s.r. to Dermatophytosis in children -An open labelled single arm clinical trial |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashok kumar |
| Designation |
M.D. Scholar |
| Affiliation |
institute of teaching and research in ayurveda, itra jamnagar |
| Address |
5th floor
academic building
institute of teaching and research in ayurveda
itra jamnagar gujrat
Jamnagar GUJARAT 361008 India |
| Phone |
7891213971 |
| Fax |
|
| Email |
ashokverma675@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Apexa G Vyas |
| Designation |
Reader |
| Affiliation |
Institute of teaching and research in ayurveda, itra jamnagar |
| Address |
5th floor, Academic building Institute of teaching and research in ayurveda,
ITRA Jamnagar Gujarat
Jamnagar GUJARAT 361008 India |
| Phone |
8767313802 |
| Fax |
|
| Email |
dr_apexa_r@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Ashok kumar |
| Designation |
M.D. Scholar |
| Affiliation |
institute of teaching and research in ayurveda, itra jamnagar |
| Address |
5th floor
academic building
institute of teaching and research in ayurveda
itra jamnagar gujrat
Jamnagar GUJARAT 361008 India |
| Phone |
7891213971 |
| Fax |
|
| Email |
ashokverma675@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda Jamnagar |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda |
| Address |
Institute of Teaching and Research in Ayurveda, Opp City B division
Police station, Gurudwara road, Jamnagar, 361008, Gujarat, India |
| 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 Ashok Kumar |
Institute of Teaching and Research in Ayurveda Hospital |
OPD No: 15,
OPD of Kaumarbhritya,
OPD Block, Institute of
Teaching and Research
in Ayurveda, Jamnagar
361008
Jamnagar
GUJARAT Jamnagar GUJARAT |
7891213971
ashokverma675@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B359||Dermatophytosis, unspecified. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kusthadi Lepa, Reference: charaka chikitsa chapter 7/93, Route: Topical, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Khadirasthaka Ghanavati, Reference: Yoga Ratnakar Chikitsa Kustha 63, Route: Topical, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Patients having all signs and symptoms of Dadru which are Kandu, Raga, Mandala.
Patients are in age group of 02-16 years of either sex. |
|
| ExclusionCriteria |
| Details |
Dadru associated with other systemic disorders like Tuberculosis, Juvenile Diabetes that interfere with the course of treatment.
Chronicity more than 2 year. Dadru lesion with secondary infection or any other complicated skin condition.
more than 20cm / very large sized lessions of Dadru.
Patient is on steroid treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of intervention on signs & symptoms of Dadru. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Phathophysiology of Dermatophytosis in Children |
60 days |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
01/04/2024 |
| 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 Yet Recruiting |
| 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
|
Introduction: Dermatophytosis, also known as ringworm, is a fungal infection of the skin. Typically, it results in a red, itchy, scaly and circular rash. Hair loss may occur in the area affected. Symptoms begin four to fourteen days after exposure. Multiple areas can be affected at a given time. About 40 types of fungus can cause ringworm. They are typically of the Trichophyton, Microsporum or Epidermophyton type. Risk factors include using public showers, contact sports such as wrestling, excessive sweating, contact with animals, obesity and poor immune function. Globally, up to 20% of the population may be infected by ringworm at any given time. Infections of the groin are more common in males, while infections of the scalp and body occur equally in both sexes. Infections of the scalp are most common in children while infections of the groin are most common in the elderly. As Kusthadi Lepa and Khadirasthaka Ghanavati is mentioned in ayurvedic classics for the management of Dadru but still no research work or documentation is available on the use and efficacy of this drug in the management of the Dadru in children. Information on the Trial procedure and Drug: In this present research work, patient registered at OPD of department of Kaumarbhritya, fulfilling the inclusion criteria will be single group randomly. The duration of the treatment is 4 weeks along with 2 weeks follow up. We assure that we will prepare formulations as per S.O.P in the pharmacy of I.T.R.A. Follow-up: After completion of the treatment, the patient will be followed up for 2 weeks at the interval of 7 days. Side Effects: We will follow closely and keep track of any unwanted side effects. We may use any other medicine or stop the usage of drug to decrease the symptoms of the side effects. Results: Data generated during the above study will be presented in a systemic manner and shall be analized statistically. Benefits: Project will help us to resolve the research question. There may not be any benefit for the society at this stage of the research, but future generations are likely to be benefited as to find out proper treatment protocol for the management of Dadru. Collected information from this research project will be kept confidential, all outcomes will be noted in tabular form and appropriate statistical tests will be applied to compare the effect. |