| CTRI Number |
CTRI/2025/09/094555 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of individualized homoeopathic medicine in treatment of scabies among children and adolescents by using Kent’s repertory. |
|
Scientific Title of Study
|
Effectiveness Of Individualized Homoeopathic Medicine In Treatment Of Scabies Among Children And Adolescents By Using Kent’s Repertory: A Single-Group Pre-Post Interventional Study. |
| 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. DISHA JODDAR |
| Designation |
Postgraduate Trainee Of Homoeopathic Repertory and case taking |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical college and Hospital |
| Address |
Mahesh Bhattacharyya Homoeopathic medical college and Hospital, Sailen Manna Sarani, Doomurjola, Howrah, WB - 711104
Sailen Manna Sarani, Doomurjola Howrah, WB-711104
Haora
WEST BENGAL
711104
India |
| Phone |
8584949479 |
| Fax |
|
| Email |
dishajoddar99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. SAMIT DEY |
| Designation |
Prof .Dr. And H.O.D. of Homoeopathic Repertory and Case Taking |
| Affiliation |
MBHMC and H Sailen Manna Sarani Doomurjola Howrah711104 |
| Address |
MBHMC and H Sailen Manna Sarani Doomurjola Howrah
MBHMC and H Sailen Manna Sarani Doomurjola Howrah
Haora
WEST BENGAL
711104
India |
| Phone |
9875371414 |
| Fax |
|
| Email |
dr.samit77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. SAMIT DEY |
| Designation |
Prof. Dr. H.O.D. Dept of Homoeopathic Repertory and Case Taking |
| Affiliation |
Mahesh Bhattacharyya Homoeopathic Medical college and Hospital |
| Address |
Mahesh Bhattacharyya Homoeopathic medical college and Hospital, Sailen Manna Sarani, Doomurjola, Howrah
Sailen Manna Sarani, Doomurjola, Howrah
Haora
WEST BENGAL
711104
India |
| Phone |
9875371414 |
| Fax |
|
| Email |
dr.samit77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahesh Bhattacharyya Homoeopathic Medical college and Hospital Sailen Manna sarani Doomurjola Howrah WB 711104 |
|
|
Primary Sponsor
|
| Name |
Mahesh Bhattacharyya Homoeopathic medical College and hospital |
| Address |
Sailen Manna Sarani Doomurjola Howrah WB 711104 |
| Type of Sponsor |
Government 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 |
| Dr Disha Joddar |
Mahesh Bhattacharyya Homoeopathic medical College and hospital |
Room no 9 pg opd Department of Homoeopathic Repertory and Case Taking of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital Sailen Manna Sarani Doomurjola Howrah WB 711104
Haora
WEST BENGAL |
8584949479
dishajoddar99@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Mahesh Bhattacharyya Homoeopathic Medical College And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicine |
All patients enrolled in the study will receive homoeopathic medicines on the basis of individualization. Both Centesimal and Fifty Millesimal potencies will be used and all medicines procured will be GMP certified and will be dispensed from the dispensary of MBHMCANDH.All the medicines will be administerd orally.Each dose cosists of 4 medicated globules no 20 or 1 poppy seed globule no 10 in 100ml aqua dist 1/4th ml RS mft mist marked 16 doses.The Dose and potency will be prescribed as per susceptibility of the patients as per guideline of organon of medicine.Duration of intervention is 3 months for each individual patient.Along with medicines the patient will receive concomitant care advice with proper Diet and regimen according to individual patient requirements. |
| Comparator Agent |
NIL |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Self reporting patients with Scabies presenting with minimum of 2 characteristics sign and symptoms located in solitary areas of fingers wrists or arms or legs and belt area or armpits or on the genitals or breasts palm sole and ankles and scalp or combination of all severe itch often worse at night itchy lines or linear burrows and bumps papules.
Age group of 5 to 16 years of all sexes.
Parental consent and children with written informed assent from their parents or legal guardian. |
|
| ExclusionCriteria |
| Details |
Patient with already under the treatment of topical or any allopathic medicine or ointment for scabies for last 3 weeks.
Undergoing homoeopathic treatment for any chronic disease within last 3 weeks.
patients suffering from severe hypersensitivity allergic skin condition or pursuing any other secondary bacterial infection. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be reduction in clinical signs and symptoms of SCABIES. |
Patients will be asked to report at suitable intervals of 15 days for the next 3 OPD consecutive months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SECONDARY OUTCOME is CDLQI questionnaire English and Bengali and Hindi version for reduction of symptoms of scabies to improve the quality of life |
Patients will be asked to report at suitable intervals of 15 days for the next 3 consecutive months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
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) |
Open to Recruitment |
|
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
|
This is a single group pre post interventional study. The aim of the study is to evaluate the role of individualized homoeopathic medicine in the treatment of scabies among children and adolescents about 5 to 16 years with the help of Kents repertory . The primary objective is to assess clinical improvement in scabies itching or burrows or papules vesicles nodules crusts etc.The secondary objective is to assess reduction of symptoms with improvement in quality of life using the CDLQI Children Dermatology Life Quality Index questionnaire. Each patient will be followed in 12 months of study at 15 day intervals for 3 consecutive months. And a diagnosis of scabies will be confirmed by microscopy of the skin scrapings or by dermatoscopy, depending on parental or legal guardian consent. Individualized homeopathic medicines will be prescribed based on the totality of symptoms through detailed casetaking analysis and evaluation as per the guideline of the Organon of Medicine with proper repertorization. Both centesimal and fifty millesimal potencies will be used and all medicines procured will be GMP certified and the medicines will be dispensed from the dispensary of MBHMCANDH. Also, all patients enrolled in the study will receive individualized homeopathic medicines along with concomitant care advice regarding proper diet and regimen according to individual patients requirements. |