| CTRI Number |
CTRI/2025/03/081542 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role Of Individualized Homoeopathic Medicine In The Treatment Of Seborrheic Dermatitis in age group of 5-50years |
|
Scientific Title of Study
|
Effectiveness Of Individualized Homoeopathic Medicine In The Treatment Of Seborrheic Dermatitis In Age Group Of 5-50 Years |
| 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 Divya Singh |
| Designation |
PG Scholar |
| Affiliation |
B.V.D.U. Homoeopathic Medical College and Hospital, Dept of Post Graduate and Research Centre, Pune |
| Address |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic
Medical College and Hospital, Dept of Post Graduate And Research
Centre, Dept of Organon, Third floor, Pune
411043, Maharashtra
India
Pune
MAHARASHTRA
411043
India |
| Phone |
9696457563 |
| Fax |
|
| Email |
drdivyasingh95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushma Suresh Manhas |
| Designation |
MD(Hom)Professor Of Organon Of Medicine And Homoeopathic Philosophy |
| Affiliation |
B.V.D.U. Homoeopathic Medical College and Hospital, Dept of Post Graduate and Research Centre, Pune |
| Address |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic
Medical College and Hospital, Dept of Post Graduate And Research centre ,Dept of Organon, Third floor, Pune 411043
MAHARASHTRA, India
Pune
MAHARASHTRA
411043
India |
| Phone |
9822322533 |
| Fax |
|
| Email |
sushma.manhas@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushma Suresh Manhas |
| Designation |
MD(Hom)Professor Of Organon Of Medicine And Homoeopathic Philosophy |
| Affiliation |
B.V.D.U. Homoeopathic Medical College and Hospital, Dept of Post Graduate and Research Centre, Pune |
| Address |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic
Medical College and Hospital, Dept of Post Graduate And Research
Centre, Dept of Organon, Third floor, Pune 411043
MAHARASHTRA, India
Pune
MAHARASHTRA
411043
India |
| Phone |
9822322533 |
| Fax |
|
| Email |
sushma.manhas@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| B.V.D.U. Homoeopathic Medical College and Hospital, Dept of Post Graduate and Research
Centre,Pune, Maharashtra, India 411043. |
|
|
Primary Sponsor
|
| Name |
Dr Divya Singh |
| Address |
Bharati Vidyapeeth (Deemed to be University) Homoeopathic
Medical College and Homoeopathic Hospital, Dept of Post Graduate
And Research Centre, Pune, Maharashtra, India 411043 |
| 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 Divya Singh |
BVDUHMC, Dept of Post Graduate and Research Centre, Dept of Organon of medicine and Philosophy |
Bharati Vidyapeeth
(Deemed to be
University)
Homoeopathic Medical
College and
Homoeopathic Hospital,
Dept of Post Graduate
And Research Centre,
Pune-Banglore
Highway, Pune- 411043
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9696457563
drdivyasingh95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Bharati Vidyapeeth (DTU) HMC, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L219||Seborrheic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Individualized Homoeopathic Medicine will be administered in the form of globules and powder through oral route. Further doses will be administered according to the requirement of the patient. Dose - Dose will depend on the susceptibility of patient. Frequency - It will be decided according to requirement of the patient. Route of Administration - Oral route. Duration of Therapy - 6 months. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects suffering from seborrheic dermatitis for 1 year or longer.
2.Subjects in age group of 5-50 years of both sexes.
3.Subjects already undergoing regular oral/topical conventional therapy for seborrheic dermatitis may be recruited only if the medications are stopped completely 3 months prior to the treatment.
|
|
| ExclusionCriteria |
| Details |
1.Subjects under the treatment of any other therapy.
2.Subjects having another serious chronic disease.
3.Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life threating illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effectiveness of individualized homoeopathic medicine in the treatment of seborrheic dermatitis in age group of 5 - 50 years. |
Role of individualized homoeopathic medicine in the treatment of seborrheic dermatitis in age group of 5 - 50 years. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the effectiveness of individualized homoeopathic medicine in the treatment of seborrheic dermatitis.
2.To assess the improvement of patient in seborrheic dermatitis by comparing the changes in POSCORAD score before and after the treatment
3.To improve quality of life of patient by reducing seborrheic dermatitis and improving the overall skin conditions. |
Score of the POSCORAD index will be calculated at the time of enrollment of patient and at the end of last follow ups.The score of DLQI questionnaire will be calculated at the time of enrollment of patient and at every 15 days of follow ups for 6 months. |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 3 |
|
Date of First Enrollment (India)
|
20/03/2025 |
| 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="1"
Days="6" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
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)
|
To study the effectiveness of individualized homoeopathic medicine in the treatment of seborrheic dermatitis in age group of 5 -50 years. The study will be done on 34 patients at BVDUHMC Pune. The patients will be followed up after every 15 days to assess their score of POSCORAD index to evaluate their improvement in seborrheic dermatitis and will be asked questions from DLQI questionnaire to assess the improvement in patient’s quality of life. Outcome assessment will be done based on the data collected from the score of POSCORAD index and the score of DLQI questionnaire before and after giving the Individualized Homoeopathic Medicine.
|