| CTRI Number |
CTRI/2026/02/103281 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
07/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on Porkaiyan chooranam for the treatment of Dyslexia in children |
|
Scientific Title of Study
|
Preclinical and clinical evaluation of the effect on PORKAIYAN CHOORANAM in the management of KATTRAL UCHARIPPU KURAIPAADU( DYSLEXIA) 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 |
Dr S VIJI |
| Designation |
PG SCHOLAR |
| Affiliation |
Government Siddha Medical College and Hospital,Palayamkottai |
| Address |
PG Second Year,Department Of Kuzhanthai Maruthuvam,Government Siddha Medical College and Hospital,Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8111071613 |
| Fax |
|
| Email |
vijisekar.soorai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr J SRIRAM |
| Designation |
Lecturer Grade II |
| Affiliation |
Government Siddha Medical College and Hospital,Palayamkottai |
| Address |
Department Of Kuzhanthai Maruthuvam,Government Siddha Medical College and Hospital,Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9486811230 |
| Fax |
|
| Email |
sriramsiddha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr J SRIRAM |
| Designation |
Lecturer Grade II |
| Affiliation |
Government Siddha Medical College and Hospital,Palayamkottai |
| Address |
Department Of Kuzhanthai Maruthuvam,Government Siddha Medical College and Hospital,Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9486811230 |
| Fax |
|
| Email |
sriramsiddha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College and Hospital,Palayamkottai |
|
|
Primary Sponsor
|
| Name |
Dr S VIJI |
| Address |
PG Second Year,Department Of Kuzhanthai Maruthuvam,Government Siddha Medical College and Hospital,Palayamkottai,Tirunelveli |
| 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 S VIJI |
Government Siddha Medical College and Hospital,Palayamkottai |
Department Of Kuzhanthai Maruthuvam,Government Siddha Medical College and Hospital,Palayamkottai
Tirunelveli
TAMIL NADU |
8111071613
vijisekar.soorai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(2025-2027) GOVT . SIDDHA MEDICAL COLLEGE & HOSPITAL ,PALAYAMKOTTAI ,TIRUNELVELI -627002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F71||Moderate intellectual disabilities, (2) ICD-10 Condition: F71||Moderate intellectual disabilities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Porkaiyan chooranam (internal medicine) |
Should be administered orally
twice a day morning with honey and night with cow ghee after food.Dosage 500-1g according to the age of patients.Duration 48 days
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Confirmed diagnosis
Dyslexia
Autism
IQ above 85
Consent
School attendance |
|
| ExclusionCriteria |
| Details |
Children above 12 years
Children below 6 years
IQ LESS than 85
Major neurological conditions (seizures,Brain trauma)
Psychiatric illness (schizophrenia) |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will help to understand the effect of PORKAIYAN CHOORANAM in the management of KATTRAL UCHARIPPU KURAIPAADU (DYSLEXIA) and may provide a better improvement in health care of children |
The study outcomes, including symptomatic relief, reduction in recurrence, and improvement in quality of life, will be assessed at predefined time points—at baseline (Day 0), during treatment (Day 28), and at the end of treatment (Day 48)—to evaluate the efficacy of porkaiyan Chooranam in the management of Kattral ucharippu kuraipaadu (Dyslexia)in children. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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
|
BACK GROUND Siddha attributes mental and neurological function to balance of vali(vatham). Dyslexia can be seen as a manifestation of vatha disturbance especially affecting the nerve conduction and brain processing Dyslexia is a neurodevelopmental disorder characterized by difficulty in reading, especially in decoding (sounding out) words despite adequate intelligence, education,poor spelling, writing skills, challenges in phonological processing (identifying and manipulating sounds in words). 5 to 15 percentage of the global population is estimated to have a form of dyslexia The conservative management for Dyslexia includes CNS stimulant treatment followed by symptomatic management
OBJECTIVE The objective of the study is to evaluate the effect of PORKAIYAN CHOORANAM in the management of KATTRAL UCHARIPPU KURAIPAADU (DYSLEXIA) in children and following aims are framed to address |