| CTRI Number |
CTRI/2021/08/035820 [Registered on: 19/08/2021] Trial Registered Prospectively |
| Last Modified On: |
30/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical evalution of Oma Ilagam (Internal) and Sangamver Thylam (External)for the managaement of Kalanjapadai(Psoriasis) in children |
|
Scientific Title of Study
|
Clinical evalution of oma ilagam (internal) and sangamver thylam (external) for kalanjapadai (psoriasis) in children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr A Maruthabarani |
| Designation |
Pg scholar |
| Affiliation |
National institite of siddha |
| Address |
Room no 9
Department of Kuzhandhai Maruthuvam
National institute of siddha
Tamabaram sanatorium
Kancheepuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
7708626626 |
| Fax |
|
| Email |
drmaruthabarani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Suresh |
| Designation |
Professor HoD |
| Affiliation |
National institute of siddha |
| Address |
Room no 9
Department of Kuzhandhai Maruthuvam
National institute of siddha
Tamabaram sanatorium
Kancheepuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962571137 |
| Fax |
04422381314 |
| Email |
drsureshherbal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Maruthabharani |
| Designation |
PG Scholar |
| Affiliation |
National institute of siddha |
| Address |
Room no 9
Department of Kuzhandhai Maruthuvam
National institute of siddha
Tamabaram sanatorium
Kancheepuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
7708626626 |
| Fax |
04422381314 |
| Email |
drmaruthabarani@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institite of siddha |
|
|
Primary Sponsor
|
| Name |
OPD IPD Ayothidoss Pandithar hospital National institite of siddha |
| Address |
Room no 9
Department of Kuzhandhai Maruthuvam
National institute of siddha
Tamabaram sanatorium
Kancheepuram
|
| 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 A Maruthabarani |
OPD IPD Ayothidoss pandithar hospital National institite of siddha |
Room no 9
Department of Kuzhandhai Maruthuvam
National institute of siddha
Tamabaram sanatorium
Kancheepuram
Kancheepuram
TAMIL NADU |
7708626626
drmaruthabarani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L409||Psoriasis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not appilicable |
| Intervention |
Oma ilagam (internal)
Sangamver thylam (external) |
Oma ilagam is given with milk twice a day after food
Dosage
5-7 years - 1.3gm
8-12 years - 2.6gm
Sangamver thylam is applied externally |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patient with two or more of the following symptoms
Scaling
Erythema
With or without itching
Candle crease sign positive
Dryness of skin
Cracks followed by itching
Auspitz sign positive
Thickness |
|
| ExclusionCriteria |
| Details |
Psoriatic arthritis
Eczema
Psoriasis with evidence od any other skin disease
Fungal infection
Any other systemic disorder
Lesion with secondary infection
Epilepsy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efiicacy of the trial drug is measured by PASI score and improvement in the clinical condition is assured by reducing the degrees of involvement of the body region from 5 to 1 |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in the remission of the disease and improvement in the qualitu of life in children
Quality of life will be measured with standard published questionarie |
Before and after treament assessment in interval of 45 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/08/2021 |
| Date of Study Completion (India) |
18/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
18/04/2022 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Psoriasis is a common chronic skin disease In the pediatric OPD of NIS nearly 10000 patient had recorded with the symptom of psoriasis from 2018 to 2019 Children are not aware of this condition because it doesnot cause any painful symptom to them The selected experimental drugs namely oma ilagam and sangamver thylam are indicated for the disease kuttam according to siddha literature including kalanjapadai |