| CTRI Number |
CTRI/2023/05/052800 [Registered on: 17/05/2023] Trial Registered Prospectively |
| Last Modified On: |
17/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathic Medicine in the treatment of Seborrheic Dermatitis in middle age population |
|
Scientific Title of Study
|
Usefulness of Individualized Homoeopathic Medicine in the Treatment of Seborrheic Dermatitis In Middle Age Population -Prospective Observational Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not Applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi Bhasin |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine Room no.16,17
Basement
Bakson Homoeopathic Medical College and Hospital 36 B Knowledge Park Phase 1 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9999455369 |
| Fax |
|
| Email |
aditi.bhasinbakson@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aditi Bhasin |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine Room no.16,17
Basement
Bakson Homoeopathic Medical College and Hospital 36 B Knowledge Park Phase 1 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9999455369 |
| Fax |
|
| Email |
aditi.bhasinbakson@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshay Mathur |
| Designation |
HOD & Guide |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine Room no.16,17
Basement
Bakson Homoeopathic Medical College and Hospital 36 B Knowledge Park Phase 1 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9868121727 |
| Fax |
|
| Email |
drakshaymathur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College & Hospital |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College and Hospital |
| Address |
G 22 Ground Floor Bakson Homoeopathic Medical college and Hospital 36 B Knowledge Park Phase 1 Greater Noida Gautam Buddha Nagar Uttar Pradesh |
| 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 |
| Aditi Bhasin |
Bakson Homoeopathic Medical College and Hospital |
Out Patient Department (OPD) Room No 1 Ground Floor Bakson Homoeopathic Medical college and Hospital 36 B Knowledge Park Phase 1 Greater Noida Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH |
9999455369
aditi.bhasinbakson@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee , Bakson Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L21||Seborrheic dermatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicines |
Oral route of administration pill form 30 pill size first dosage after case taking repetition according to follow up follow up every 15 days for a period of 6 months |
| Comparator Agent |
Nil |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Patients with age group between 30-59 years of age.
Patients of Both Gender.
Patients having adult variant of seborrheic dermatitis
|
|
| ExclusionCriteria |
| Details |
Subjects who are currently undergoing treatment with ayurvedic or conventional therapies and do not wish to discontinue their treatment of seborrheic dermatitis at least 15 days prior to baseline visit.
Subjects with history of chronic alcohol or drug abuse within 6 months of initiation of study.
Females who are pregnant or newlyweds who are likely to get pregnant and those who are breast feeding.
Subjects with any other condition on the treatment areas similar to the disease in study as that could be a confounding factor.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Positive changes on Clinical Severity Score of Seborrheic Dermatitis - Lower score indicating better results in complaints |
Clinical Severity Score of Seborrheic Dermatitis to be used at baseline, 12 weeks and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Not Applicable |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
28/05/2023 |
| 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="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study aims to assess the role of Homoeopathy in the treatment of Seborrheic Dermatitis in the patients of middle age group 30-59. 15 months of study with 6 month enrollment, 6 month follow up and 3 months of evaluation. Clinical Severity score to assess the condition of patients. |