| CTRI Number |
CTRI/2026/03/105674 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effectiveness of Scabies Control Interventions in Bangladesh |
|
Scientific Title of Study
|
Effectiveness of Different Scabies Control Interventions among Madrasa Students of Tungipara Sub-district, Bangladesh |
| 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 Tanvir Ahmed |
| Designation |
Upazila Health and Family Planning Officer |
| Affiliation |
Office of the Upazila Health and Family Planning Officer |
| Address |
158 Sobujbag Road Chandmari Gopalganj Sadar
Bangladesh
8100
Other |
| Phone |
8801717025358 |
| Fax |
|
| Email |
tanvir.cmc03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tanvir Ahmed |
| Designation |
Upazila Health and Family Planning Officer |
| Affiliation |
Office of the Upazila Health and Family Planning Officer |
| Address |
158 Sobujbag Road Chandmari Gopalganj Sadar
Bangladesh
8100
Other |
| Phone |
8801717025358 |
| Fax |
|
| Email |
tanvir.cmc03@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanvir Ahmed |
| Designation |
Upazila Health and Family Planning Officer |
| Affiliation |
Office of the Upazila Health and Family Planning Officer |
| Address |
158 Sobujbag Road Chandmari Gopalganj Sadar
Bangladesh
8100
Other |
| Phone |
8801717025358 |
| Fax |
|
| Email |
tanvir.cmc03@gmail.com |
|
|
Source of Monetary or Material Support
|
| Local Government, Upazila Parishad, Tungipara, Gopalganj, Postal Code: 8121, Bangladesh |
|
|
Primary Sponsor
|
| Name |
Dr Tanvir Ahmed |
| Address |
Office of the Upazila Health and Family Planning Officer, Tungipara, Gopalganj, Bangladesh - 8710 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tanvir Ahmed |
Upazila Health Complex, Tungipara |
Upazila Health Complex Tungipara Gopalganj 8710 Bangladesh
|
8801717025358
tanvir.cmc03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Review Committee Gopalganj Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Absence of relevant disease (B86||Scabies) |
| Patients |
(1) ICD-10 Condition: B86||Scabies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ivermectin Oral Tablet |
200 microgram per kg body weight taken orally on day 0 and day 7 |
| Intervention |
Permethrin 5% Topical Cream |
15gm (children) or 30gm (adults) tube applied overnight on day 0 and day 7 |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All students teachers and staff of participating madrassas who are aged 5 years or above and residing in the boarding facility |
|
| ExclusionCriteria |
| Details |
Known allergies or contraindication to permethrin or oral ivermectin; Received treatment for scabies within last 14 days; Pregnancy (for ivermectin groups); Body weight below 15 kg (for ivermectin groups) ; Non-boarding madrassa students; Madrassas currently in any scabies or other skin treatment program; Madrassas not willing to participate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Point prevalence of active scabies |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Point prevalence of scabies |
06 months and 12 months |
| Reinfestation rates |
06 months and 12 months |
| Incident cases between follow up period |
06 months and 12 months |
| Adverse events or serious side effects |
1 month 06 months and 12 months |
| Acceptability of topical permethrin or oral ivermectin |
1 month 06 months and 12 months |
| Adherence to interventions and health education |
06 months and 12 months |
| Changes in hygiene-related knowledge attitudes and practices (KAP) |
06 months and 12 months |
| Per-student cost of interventions |
Baseline 1 month 06 months and 12 months |
| Incremental cost-effectiveness ratio (ICER) |
Baseline 1 month 06 months and 12 months |
| Barriers and facilitators to scabies management program |
Baseline 1 month 06 months and 12 months |
|
|
Target Sample Size
|
Total Sample Size="1600"
Sample Size from India="0"
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 4 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/03/2026 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
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
|
Scabies is a parasitic skin infestation caused by Sarcoptes scabiei affecting millions worldwide particularly in overcrowded settings like madrassas in Bangladesh. This cluster randomized controlled trial aims to compare the effectiveness of different public health approaches for controlling scabies among madrassa students in Tungipara Subdistrict Bangladesh.
A total of 16 madrassas with approximately 1600 participants will be randomly allocated to four intervention groups. Arm A receives Mass Drug Administration plus health education with either Permethrin 5 percent cream or Oral Ivermectin (200 microgram per kg body weight). Arm B receives targeted therapy (cases and close contacts only) plus health education with the same drugs. Topical Permethrin is applied overnight for two rounds seven days apart. Oral Ivermectin is taken on empty stomach for two rounds seven days apart.
The primary outcome is point prevalence of active scabies at one month post intervention. Secondary outcomes include prevalence and reinfestation rates at 06 and 12 months adverse events acceptability adherence changes in hygiene related knowledge attitudes and practices cost effectiveness and barriers and facilitators to program implementation.
This study will provide evidence on optimal public health strategies for scabies control in high risk institutional settings and inform routine program implementation in Bangladesh. |