| CTRI Number |
CTRI/2025/04/084861 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on siddha formulation Seenthil Sarkarai and Mathan Thailam in children for Padarthamarai(Dermatophytosis) |
|
Scientific Title of Study
|
Clinical evaluation of Seenthil Sarkarai (Internal) and Mathan Thailam (External)for the management of Padarthamarai
(Dermatophytosis) in children among out-patients attending of Ayothidass Pandithar Hospital,National Institute of Siddha |
| 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 PBhavatharani |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 16/17,Department of kuzhanthai Maruthuvam,National Institute of Siddha,
Tambaram Sanatorium,Chennai-47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9361947973 |
| Fax |
|
| Email |
bhavatharanipugazh1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Meenakshi Sundram |
| Designation |
Professor and Head of the Departmentt |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 16/17,Department of kuzhanthai Maruthuvam,National Institute of Siddha,Tambaram Sanatorium,Chennai-47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444214582 |
| Fax |
|
| Email |
mmssiddha@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Meenakshi Sundram |
| Designation |
Professor and Head of the Departmentt |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 16/17,Department of kuzhanthai Maruthuvam,National Institute of Siddha,Tambaram Sanatorium,Chennai-47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444214582 |
| Fax |
|
| Email |
mmssiddha@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha,Tambaram Sanatorium,Chennai-47 |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Room no 16/17,Department of kuzhanthai Maruthuvam,National Institute of Siddha,
Tambaram Sanatorium,Chennai-47 |
| 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 PBhavatharani |
Ayothidoss Pandithar Hospital |
Room no 16/17,Department of kuzhanthai Maruthuvam,National Institute of Siddha,
Tambaram Sanatorium,Chennai-47
Kancheepuram
TAMIL NADU |
09361947973
bhavatharanipugazh1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Siddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B359||Dermatophytosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MATHAN THYLAM
|
MATHAN THYLAM:Required quantity
duration-48 days |
| Comparator Agent |
Nil |
Nil |
| Intervention |
SEENTHIL SARKARAI
|
SEENTHIL SARKARAI:Dose will be given according to weight of the child using Clark’s rule.
duration-48 days
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Participants with clinical features of Padarthamarai (Dermatophytosis)
NRS below 6 points(moderate) and CDLQI below 10 score(moderate)will be included. |
|
| ExclusionCriteria |
| Details |
Known cases of Skin diseases like contact dermatitis,vitiligo,psoriasis,atopic dermatitis.
Other diseases or medications that might directly interfere in the study
Diabetes mellitus -Type 1 in participants
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of signs and symptoms of Dermatophytosis by NRS 0 point (no itching) and CDLQI 0 score (no effects on participant’s life) after treatment is expected in study participants. |
Reduction of signs and symptoms of Dermatophytosis will be assessed after the period of 48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
26/04/2025 |
| 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
|
BACKROUND: Dermatophytosis(ICD-11-1F28)isthemostimportant groupofsuperficialfungalinfections caused bydermatophytes, which is a group of fungi that are capable of growing by invadingthe keratin of skin, hair, and nail for obtaining nutrients. There are several reports on intracontinental variability of the global incidence because of the change in climatic condition across the world.[1]According to World Health Organization (WHO), the prevalence rate of superficial mycotic infection worldwide has been found to be 20-25%. [2] It is more prevalent in tropical and subtropical countries like India where the heat and humidityis high for most part of the year. [3]Environmental factors include high temperature and relative humidity, which provide conditions favourable to fungal dispersion and development. Sociodemographic factors, such as poor socioeconomic status, promiscuity, prolonged contact withanimals,andpoorhygieneconditions,arealsoconducivetotheincidenceandpropagationof mycotic infections. [4]
DermatophytesincludeseveralgeneralikeTrichophyton,MicrosporumandEpidermophyton.SomecommonorganismsincludeTrichophytonsudanese,Trichophytontonsurans,Trichophyton verrucous,Trichophyton rubrum, and Microsporum canis. [5] Padarthamarai is one of the common skin disease(kuttam).In Siddha concept,kuttam is a broad term used to denote skin diseases. Yugi muni classified skin disease into 18 types. Padarthamarai can be equated to the most important cutaneous fungal infection due to dermatophytes. Tinea is a common fungal infection which often spreads from one person to another easily through skin contact. Children are more prone than adults since creating awareness among them may be difficult and they get easy skincontact in common places like schools. Also fungal infections are being resistant to medicines in recent days due to frequent use of antibiotics. I have chosen “PADARTHAMARAI” (ISMT4.12.55) as my dissertation topic. Siddha texts describes that padarthamarai is an annular skin lesion in which patches are red in the centre and darkredonedgesresemblingthepetalsoflotusso.ItisalsocalledasPundareegamkuttamThese symptoms are similar to the symptoms of dermatophytoses of modern literature ,Antifungal propertypertainingdrugsareusedtotreatpadarthamarai.Consideringandreviewingalltheabove Seenthil sarkari as internal medicine and Mathan thailam as external application is chosen for PADARTHAMARAI in children for my dissertation. OBJECTIVE:To evaluatethe therapeuticeffectiveness of theSeenthilsarkaraiasinternalandMathan thailam as external in the management of Padarthamarai (Dermatophytosis) in children. METHODOLOGY: Studydesignandconduct ofthestudy Studytype:Anopen-label,Single-arm,Single-centrephaseIIclinicaltrial. Studyplace:AyothidossPanditharHospital,NationalInstituteofSiddha,TambaramSanatorium, Chennai-47
Studyperiod: 18Months
PopulationAndSample: 6-12agegroupfulfillingalltheinclusioncriteriaandpassingtheexclusioncriteriamentionedbelow
Number of Patients : 30 participants
INCLUSION CRITERIA: 1.
Age: 6-12 years 2.
Sex: Both male and
female children. 3.
Participants with clinical
features of Padarthamarai (Dermatophytosis) 4.
NRS below 6 points(moderate) and CDLQI below 10 score(moderate) will be included EXCLUSION CRITERIA:
1.
Known cases of Skin diseases
like contact dermatitis, vitiligo, psoriasis, atopic
dermatitis.
2.
Other diseases or medications that might directly
interfere in the study.
3.
Diabetes mellitus-Type 1 in
participants. EXPECTED OUTCOME
: Reduction of signs and symptoms
of Dermatophytosis by NRS 0 point (no itching) and CDLQI 0 score (no effects
on participant’s life) after treatment is expected in study
participants. RESULTS AND DISCUSSION:The Result will be statistically analysed and reported. KEYWORDS: Seenthil Sarkarai, Mathan Thailam,Padarthamarai,Dermatophytosis
|