| CTRI Number |
CTRI/2025/04/086007 [Registered on: 30/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Naaval Nei (Internal) for Kudal Kirumi (Ascariasis) |
|
Scientific Title of Study
|
Phase II Non-Randomized clinical study on Kudal Kirumi (Naaga Puchi Noi)-Ascariasis with the evaluation of siddha trial drug Naaval Nei 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 Thanusha V |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College, Arumbakkam, Chennai |
| Address |
Post Graduate Room number 25, Department of PG Kuzhandhai Maruthuvam, Government Siddha Medical College, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9994180338 |
| Fax |
|
| Email |
thanu.v1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Satheesh Kumar |
| Designation |
Lecturer II, Department of PG Kuzhandhai Maruthuvam |
| Affiliation |
Government Siddha Medical College, Arumbakkam, Chennai |
| Address |
Post Graduate Room number 25, Department of PG Kuzhandhai Maruthuvam, Government Siddha Medical College, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9962066694 |
| Fax |
|
| Email |
drsatheeshkumarsiddha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Thanusha V |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College, Arumbakkam, Chennai |
| Address |
Post Graduate Room number 25 Department of PG Kuzhandhai Maruthuvam, Government Siddha Medical College, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9994180338 |
| Fax |
|
| Email |
thanu.v1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College, Arumbakkam, Chennai 600106
Tamilnadu, India. |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
No 6 Anna Arch Road NSK Nagar Arumbakkam Chennai 600106 |
| Type of Sponsor |
Government medical college |
|
|
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 Thanusha V |
Government Siddha Medical College |
Room No.25, Department of PG Kuzhandhai Maruthuvam, Arignar Anna Government Hospital of Indian Medicine, NSK Nagar, Arumbakkam, Chennai
Chennai
TAMIL NADU |
9994180338
thanu.v1999@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: B779||Ascariasis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Naaval Nei (Internal) |
Naaval Nei 2 to 4 ml once a day for 5 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Loss of appetite, Pain around umbilicus, Presence of perianal itching, History of passing worms in the stools, Teeth grinding during sleep (Bruxism). |
|
| ExclusionCriteria |
| Details |
Enteric fever, Amoebiasis, Severe dehydration, Severe anemia (Hemoglobin less than 7 gm/dl) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome will be assessed by absence of ova, cyst in motion investigations and symptoms reduced completely, increased hemoglobin level, decreased ESR and eosinophil count. |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/05/2025 |
| 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="0"
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
|
This is a single Non-Randomized open clinical trial to study the safety and efficacy of siddha trial drug Naaval Nei (Internal) in treating Kudal Kirumi (Naaga Puchi Noi) - Ascariasis. The trial drug is to be given 2 to 4 ml once a day for 5 days. Clinical trial is to be conducted after conducting pre-clinical study. The trial drug Naaval Nei has been mentioned in Madhalai Noi Thoguthi Part 1. During the trial study the related data will be recorded and documented. After the completion of trial the data will be statistically analysed. |