| CTRI Number |
CTRI/2025/02/081371 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of Albendazole, Mebendazole, Pyrantel pamoate in the treatment and prevention of recurrence of Enterobius vermicularis infection in children - a randomized control trial. |
|
Scientific Title of Study
|
comparison of efficacy of Albendazole, Mebendazole, pyrantel pamoate in achieving remission and preventing recurrence of enterobiusvermicularis infection in children using an objective remission and recurrence score - a randomized control trial. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Annaswamy V Renuka Devi |
| Designation |
post graduate |
| Affiliation |
vinayaka missions medical college and hospital |
| Address |
Room no 2, first floor, pediatric opd, department of pediatrics, Vinayaka missions medical college and hospital, Karaikal.
Karaikal
PONDICHERRY
609609
India |
| Phone |
8121818019 |
| Fax |
|
| Email |
dr.avrenuka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinoth Selvaraj |
| Designation |
Associate Professor |
| Affiliation |
vinayaka missions medical college and hospital |
| Address |
Room no 3, first floor, pediatric opd, department of pediatrics, Vinayaka missions medical college and hospital, Karaikal.
Karaikal
PONDICHERRY
609609
India |
| Phone |
9080220712 |
| Fax |
|
| Email |
rajkantmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Annaswamy V Renuka Devi |
| Designation |
post graduate |
| Affiliation |
vinayaka missions medical college and hospital |
| Address |
Room no 2, first floor, pediatric opd, department of pediatrics, Vinayaka missions medical college and hospital, Karaikal.
Karaikal
PONDICHERRY
609609
India |
| Phone |
8121818019 |
| Fax |
|
| Email |
dr.avrenuka@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka missions research foundation deemed to be university
NH 47, Sankari main road ,Salem , Tamil Nadu, India
PIN 636308 |
|
|
Primary Sponsor
|
| Name |
vinayaka missions research foundation deemed to be university |
| Address |
NH 47 ,sankari main road, salem tamil nadu 636308 |
| Type of Sponsor |
Private 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 |
| DrA V RENUKA DEVI |
vinayaka missions medical college and hospital |
Room no 2, first floor, pediatric opd, department of pediatrics, Vinayaka missions medical college and hospital, Karaikal.
Karaikal
PONDICHERRY |
8121818019
dr.avrenuka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee of vinayaka missions medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B80||Enterobiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
albendazole |
400mg first dose followed by 2nd dose after 2 weeks |
| Comparator Agent |
mebendazole |
100mg 1st dose followed by 2nd dose after 2 weeks |
| Comparator Agent |
pyrantel pamoate |
11mg per kg dose on 1st day followed by 2nd dose after 2weeks |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
All children in age group of 2-12 years attending the pediatric outpatient department with pin worm infection.
pinworm infection is diagnosed by 3 methods
1]pin worms detected on clinical examination
2]parents or attendees accompanying children bring dead or live pinworms
3]pin worms detected by parents and captured on photos or videos stamped with date, time and place(geo tagged). |
|
| ExclusionCriteria |
| Details |
All the children who already took any of three drugs under study within the past three months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| occurrence of remission in each of the arm by remission score |
0 to 8 weeks after initiation of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| occurrence of recurrence in each of the arm |
1 to 3 months of remission |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="126" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
12/03/2025 |
| Date of Study Completion (India) |
31/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published in Indian Pediatrics.
doi.org/10.1007/s13312-026-00303-w |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.avrenuka@gmail.com].
- For how long will this data be available start date provided 14-03-2026 and end date provided 14-03-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Children in the age group of 2-12 years with confirmed Enterobius vermicularis (pinworm)infection are randomized to receive albendazole ,mebendazole and pyrantel pamoate in a single dose with a repeat dose after 2 weeks. Family members of affected children are treated simultaneously. Every patient is given a hygiene diary with hygiene steps taught by principal investigator to parents and children. Children and parents are interviewed again at 2 weeks; 4 weeks; 6 weeks and 8 weeks either as in person or through video consultation after completion of treatment to know about remission and at 1month , 2 months and 3 months post remission to know about recurrence of pinworms. Since pinworm is known for auto inoculation ,retrograde infection and chronic parasitism ,remission and recurrence scores of pinworm infection for the Albendazole , Mebendazole and Pyrantel pamoate groups are compared statistically to know their efficacy .The impact of hygiene in remission and recurrence is derived from the data in hygiene diaries. The sample size was reworked with cure rates of Albendazole and Mebendazole from hook worm infection (similar helminth) since recent RCTs in pinworms are not available.The sample size came as 42 for each group. With the help from microbiology department,the worms are preserved in 75% ethyl alcohol and then seen under a microscope to confirm pinworms.Patients were included only after microscopic confirmation to rule out false positivity.Allocation concealment is ensured using serially numbered,opaque,sealed envelopes which are opened only after confirmation of participant eligibility. All the above operational and methodological refinements were made during the implementation phase prior to the data collection and analysis ,while the core study objectives and predefined outcomes remained unchanged. The study showed all the three drugs are equally efficacious, safe and well tolerated by children.Albendazole,Mebendazole and Pyrantel pamate have no significant difference in inducing remission after the two doses.The recurrence rate is significantly lower in Mebendazole group than the other two.Albendazole group has the highest recurrence rate.Hygiene role is statistically significant in preventing recurrence and not in remission.Absence of a large sample size,unequal sample distribution and absence of blinding are the limitations. The unequal group sizes occured because recruitment ended before completion of pre-generated random sequence due to unavailability of further samples.Allocation concealment was maintained throughout the study and no post-randomisation modifications were made. |