| CTRI Number |
CTRI/2025/01/079289 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
01/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha
Other (Specify) [Case Series] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Test the Effectiveness of Kudar Kirumi Naasini Chooranam and Meni Ennai in Treating Worm Infestations in Children |
|
Scientific Title of Study
|
PRECLINICAL AND CLINICAL EVALUATION OF THE EFFICACY OF KUDAR KIRUMI NAASINI CHOORANAM AND MENI ENNAI IN THE MANAGEMENT OF KIRUMIGAL (HELMINTHIC INFESTATIONS) 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 R Mahalakshmi |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli. |
| Address |
PG First Year,
Department of Kuzhanthai Maruthuvam,
Government Siddha Medical College and Hospital,
Palayamkottai,
Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7550277255 |
| Fax |
|
| Email |
lakshmimaha570.ml@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Anbumalar |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli. |
| Address |
Department of Kuzhanthai Maruthuvam,
Government Siddha Medical College and Hospital,
Palayamkottai,
Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788232433 |
| Fax |
|
| Email |
anbumalara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Anbumalar |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli. |
| Address |
Department of Kuzhanthai Maruthuvam,
Government Siddha Medical College and Hospital,
Palayamkottai,
Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788232433 |
| Fax |
|
| Email |
anbumalara@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college and hospital, Palayamkottai, Tirunelveli-627002, Tamil Nadu. |
|
|
Primary Sponsor
|
| Name |
Dr R Mahalakshmi |
| Address |
PG First 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 R Mahalakshmi |
Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, Tamil Nadu, India. |
Department of Kuzhanthai Maruthuvam, Branch IV,
Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, Tamil Nadu, India.
Tirunelveli
TAMIL NADU |
7550277255
lakshmimaha570.ml@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: B820||Intestinal helminthiasis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kudar Kirumi Naasini chooranam and Meni ennai(Internal administration) |
KUDAR KIRUMI NAASINI CHOORANAM-Mooviral alavu (800-1000 mg) twice a day with honey after food, for two days (Depends on weight of the children)
MENI ENNAI 1/4-1/2 palam (8.75ml-17.5 ml) on 3rd day in empty stomach (Depends on weight of the children)
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Pain around the Umblicus
Bruxism (Teeth grinding during sleep at night)
Pruritus ani (Itching around anus)
Loss of Appetite
History of passing worm in the stool
Anaemia
Hypo pigmented patches in skin
Patients having positive stool examination (presence of ova, cyst)
|
|
| ExclusionCriteria |
| Details |
Children of age above 12 years and below 5 years.
Amoebiasis
Patients not willing to give blood and motion sample for investigation.
Enteric fever |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will help to understand the effects of KUDAR KIRUMI NAASINI CHOORANAM AND MENI ENNAI IN THE MANAGEMENT OF HELMINTHIC INFESTATIONS(KIRUMIGAL)IN CHILDREN |
3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/02/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
27/04/2026 |
|
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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
BACKGROUND: HELMINTHIC INFESTATION is referred to as an infestation of the host specially in humans and animals by helminth. It is one of the common diseases especially for children affecting one- fourth of the world population. ➤ According to WHO, an estimated 24% of world’s population is infected with soil transmitted worms. ➤In India, 225 million pre school and school children are estimated to be at risk of infection from worms. ➤ Helminthiasis is caused by three groups of worms, Nematodes (roundworms), Cestodes (tapeworms) and Trematodes (Flukes). ➤ Intestinal worm infestations are due to lack of personal hygiene, contaminated food and water, poor socio economic status and environmental sanitation. ➤ Symptoms includes Intestinal manifestations (diarrhoea, abdominal pain), Teeth grinding during sleep at night, Itching around anus, anorexia, nausea, malnutrition. weakness and impaired growth, History of passing worm in the stool, Anaemia. Hypopigmented patches in skin. ➤ The present study was undertaken to measure the Parasite load in children and evaluate the efficacy of anthelminthic drugs. OBJECTIVE: The objective of the study is to evaluate the effect of "KUDAR KIRUMI NAASINI CHOORANAM AND MENI ENNAI" in "KIRUMIGAL(HELMINTHIC INFESTATIONS)" in children |