| CTRI Number |
CTRI/2019/06/019722 [Registered on: 18/06/2019] Trial Registered Prospectively |
| Last Modified On: |
19/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical evaluation of the effect of classical siddha drug "kirumi eṇṇey " for the treatment of Worm infestation |
|
Scientific Title of Study
|
Clinical evaluation of the effect of KIRUMI ENNAI in the management of KUDAL KIRUMIKAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ESAKKI MUTHU K |
| Designation |
post graduate student |
| Affiliation |
Government Siddha Medical College and Hospital Palayamkottai |
| Address |
Department of Kuzhanthai Maruthuvam,
Government Siddha Medical
College and Hospital
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
6381501853 |
| Fax |
|
| Email |
kavithadr94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
D K Soundararajan |
| Designation |
Professor and Head |
| Affiliation |
Government Siddha Medical College and Hospital Palayamkottai |
| Address |
Department of Kuzhanthai Maruthuvam,
Government Siddha Medical
College and Hospital
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442048801 |
| Fax |
|
| Email |
dr.dks.2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
D K Soundararajan |
| Designation |
Professor and Head |
| Affiliation |
Government Siddha Medical College and Hospital Palayamkottai |
| Address |
Department of Kuzhanthai Maruthuvam,
Government Siddha Medical
College and Hospital
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442048801 |
| Fax |
|
| Email |
dr.dks.2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College and Hospital Palayamkottai |
|
|
Primary Sponsor
|
| Name |
ESAKKI MUTHU K |
| Address |
Government Siddha Medical College and Hospital Palayamkottai |
| 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 |
| ESAKKI MUTHU K |
Government Siddha Medical College and Hospital,Palayamkottai |
Department of Kuzhanthai Maruthuvam
Government Siddha Medical College and Hospital,
Palayamkottai,
Tirunelveli-627002
Tirunelveli
TAMIL NADU |
6381501853
kavithadr94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI,TIRUNELVELI-627002,TAMIL NADU, INDIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K90-K95||Other diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KIRUMI ENNAI |
Should be administrated orally twice a day along with milk before food for a period of 5 days
Dosage:4 to 4.5gms |
| Comparator Agent |
Not applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
The patient reporting to the OPD will be screened for the following symptom and the subject with minimum 5 of the following symptom will be included in the study
1. Pain around the Umblicus
2. Bruxium (bitting the tooth during sleep at night)
3. Pruritus (itching or pain around Anus)
4. Hypopigmented patches in skin
5. Anaemia
6. Gastric distension
7. Loss of appetite
8. History of passing worm in the stool |
|
| ExclusionCriteria |
| Details |
1. Below 2 years and Above 12 years
2. Patient with chronic disease like primary complex,chronic renal failure.
3. Enteric fever
4. Amoebiasis
5. Patient not willing to give blood and motion sample for investigation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Presence of egg on stool examination for Tenia Solium,Ascaris,Hookworm,Enterobius Vermicularis. |
5 to 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduced symptoms of
1. Hypopigmented patches on skin
2. Bruxium
3. Loss of appetite |
10 to 15 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
18/06/2019 |
| Date of Study Completion (India) |
23/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
23/03/2020 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
The present study is single arm clinical trial to assess the efficacy of ’’ kirumi eṇṇey’’ for the treatment of ’’ kuá¹al kirumikaḷ ’’.
In this trial 40 patients will be recruited and the trial drug will be administrated orally 4 to 4.5gms twice a day before food along with milk for a period of 5 days age between 2 to 12 years. Primary outcome measured on 1st and 5th day secondary outcome measured on 15th day |