| CTRI Number |
CTRI/2022/03/040762 [Registered on: 03/03/2022] Trial Registered Prospectively |
| Last Modified On: |
30/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Scabies treatment by oral medicine |
|
Scientific Title of Study
|
Efficacy of two doses of Ivermectin tablet in treatment of scabies in comparison to once application of 5% Permethrin lotion- A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyamadhaba Behera |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Room no-304
Academic building
AIIMS Bhubaneswar campus
Sijua, Patrapada
Bhubaneswar
Odisha-751019
Khordha
ORISSA
751019
India |
| Phone |
9910830997 |
| Fax |
|
| Email |
cmfm_priyamadhaba@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyamadhaba Behera |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Room no-304
Academic building
AIIMS Bhubaneswar campus
Sijua, Patrapada
Bhubaneswar
Odisha-751019
Khordha
ORISSA
751019
India |
| Phone |
9910830997 |
| Fax |
|
| Email |
cmfm_priyamadhaba@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Binod Kumar Patro |
| Designation |
Professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Room no - 326
Academic building
AIIMS Bhubaneswar campus
Sijua, Patrapada
Bhubaneswar
Odisha-751019
Khordha
ORISSA
751019
India |
| Phone |
9438884013 |
| Fax |
|
| Email |
cmfm_binodp@aiimsbhubaneswar.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
Dr Priyamadhaba Behera |
| Address |
Room no -326
Academic Building
AIIMS Bhubaneswar Campus
Sijua, Patrapada
Bhubaneswar
Odisha
India-751019 |
| Type of Sponsor |
Other [Self-funded (Institution provided infrastructure) ] |
|
|
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 Priyamadhaba Behere |
Khordha |
Khordha, Odisha, India
Khordha
ORISSA |
9910830997
cmfm_priyamadhaba@aiimsbhubaneswar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute of Medical Sciences, Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B86||Scabies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral Ivermectin |
In the intervention arm, Ivermectin tablets will be given to the participants at a dose of 200 micrograms per kg body weight on day 1 and day 7. All the family and close contacts of the participants will be given Ivermectin tablets at a dose of 200 micrograms per kg body weight on day 1 and day 7 similar to participants unless contraindicated.. In case of contraindication, 5% Permethrin lotion will be given for once application of day 1 of treatment of participant. |
| Comparator Agent |
Topical 5% Permethrin |
In the control arm, 5% Permethrin lotion will be given for one-time application at bedtime all over the body from the neck down to the feet and toes. Participants will be told to bathe after 12 hours of application with soap water and to wear clean clothes. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed as a case of scabies by a physician
Patients who have given written informed consent |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women
History of allergy to Ivermectin
Children age less than 5 years
Seizure disorder
Diagnosed case of Parkinsonism
Patient treated with any topical or systemic scabicidal therapy in the month before entry
Norwegian scabies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cure rate of scabies |
Day 28 of treatment initiation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not available |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "92"
Final Enrollment numbers achieved (India)="92" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/03/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, parallel-group, two-arm controlled trial to assess the efficacy of two-dose oral Ivermectin therapy at 200 micrograms per kg body weight at seven days intervals in comparison with one dose 5% topical permethrin lotion. This study will be conducted in the Khordha district of Odisha, India. After fulfilling the eligibility criteria, participants will be recruited in either control or intervention arm by randomization. In the intervention arm, Ivermectin tablets will be given to the participants at a dose of 200 micrograms per kg body weight on day 1 and day 7. All the family and close contacts of the participants will be given Ivermectin tablets at a dose of 200 micrograms per kg body weight on day 1 and day 7 similar to participants unless contraindicated. In case of contraindication, 5% Permethrin lotion will be given for once application of day 1 of treatment of participant. In the control arm, 5% Permethrin lotion will be given for application at bedtime all over the body from the neck down to the feet and toes. Participants will be told to bathe after 12 hours of application with soap water and to wear clean clothes. All participants will be counseled for washing bedding, clothing, and towels used by participants and their household, and close contacts. Oral antihistamine tablets will be prescribed for all the participants for 14 days, whereas oral antibiotics will be prescribed for infected scabies. The outcome will be measured in the form of a cure rate. A cure is defined as a significant improvement of signs and symptoms of scabies. The cure rate will be calculated after follow up of the patient on day 28 after initiation of treatment |