| CTRI Number |
CTRI/2024/05/067535 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TO EVAUATE THE EFFECT OF INDIVIDUALISED HOMOEOPATHIC TREATMENT IN PATIENTS OF ATOPIC DERMATITIS ASSOCIATED WITH GENERALISED ANXIETY |
|
Scientific Title of Study
|
EFFECT OF INDIVIDUALISED HOMOEOPATHIC TREATMENT IN PATIENTS OF ATOPIC DERMATITIS ASSOCIATED WITH GENERALISED ANXIETY - AN OPEN LABEL PROSPECTIVE 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 Neha Biswas |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy (Kolkata) |
| Address |
OPD NO 14 Department of Organon of Medicine, National Institute
of Homoeopathy (Kolkata), Block-GE, Sector-III, Kolkata North 24
parganas WEST BENGAL 700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
|
| Fax |
|
| Email |
biswasdrneha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr INDRANI CHAKRABARTI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
National Institute of Homoeopathy (Kolkata) |
| Address |
Department of Organon of Medicine, National Institute of
Homoeopathy (Kolkata), Block-GE, Sector-III,Kolkata North 24
parganas WEST BENGAL 700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9433902555 |
| Fax |
|
| Email |
indrani.abc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr INDRANI CHAKRABARTI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
National Institute of Homoeopathy (Kolkata) |
| Address |
Department of Organon of Medicine, National Institute of
Homoeopathy (Kolkata), Block-GE, Sector-III,Kolkata North 24
parganas WEST BENGAL 700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9433902555 |
| Fax |
|
| Email |
indrani.abc@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Block GE Sector III Salt Lake Kolkta 700106 |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy, Kolkata |
| Address |
Block GE Sector III Salt Lake Kolkta 700106 |
| 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 Indrani Chakrabarti |
National Institute of Homoeopathy |
Department of Organon
of Medicine, National
Institute of
Homoeopathy
(Kolkata), Block-GE,
Sector-III,Kolkata North
24 parganas WEST
BENGAL 700106
North Twentyfour Parganas
WEST BENGAL |
9433902555
indrani.abc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee of National Institue of Homoeopathy,Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathhic Medicine |
Detailed and thorough case taking of the patient shall be done in accordance with the direction laid down by Dr. Hahnemann in the Organon of Medicine (5th and 6th edition).
Potencies, dose & repetition will strictly follow homoeopathic principles.
Homoeopathic medicines will be prescribed to all patients after individualization of the case by analysis and evaluation of symptoms.
Follow up to be done at regular intervals for consecutive 6 months.
Total duration of treatment 6 months.
|
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Atopic dermatitis fulfilling Hanifin and Rajka diagnostic criteria associated with generalised anxiety (having GAD-7 score of more than or equal to 10).
Patient age group 18-60 years, of any gender, of any religion, of any socio-economic background.
Patents must be knowing either Hindi or English or Bengali.
Patients willing to give written informed consent.
Patients already undergoing regular oral/topical conventional therapy for atopic dermatitis may be recruited only if the medications are stopped completely 3 months prior to the treatment. |
|
| ExclusionCriteria |
| Details |
Patient who are already taking medication for Generalised Anxiety for long term or to be decided as per the present general health of the patient.
Patient suffering from any life threatening/ Psychiatric/ illness or Immuno-compromised state or other significant disease condition.
Patients with malignancy of any organ.
Pregnant or lactating women.
Substance abuse and/or dependence.
Patients not willing to give consent for participation in the study.
Patients not willing to undergo any investigations if advised.
Patients who continue to be under other method of treatment or therapy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Eczema Area and Severity Index (EASI) score for atopic dermatitis.
Generalised Anxiety Disorder (GAD-7) score for generalised anxiety |
At baseline and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To ascertain and shortlist the most frequently indicated Homoeopathic medicines in the treatment of patients of atopic dermatitis associated with generalised anxiety.
To ascertain the predominant miasm in treatment of patients of atopic dermatitis associated with generalised anxiety.
|
6 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
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/05/2024 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Atopic Dermatitis is a chronic relapsing skin
condition which occupies a major portion of dermatological diseases. The
disease emerges as a social problem by increasing indirect costs, such as
visiting a doctor, absenteeism from work and school, and avoiding social
interactions.The skin is the visible reflector of emotion and psychological disorder
being just like a sensitive photographic plate on which emotional states such
as anger by flushing, embarrassment by blushing and fear by paleness etc. are
reflected. Hence
this study is to show the efficacy of the individualised homoeopathic medicine
on atopic dermatitis and to find out if there is any correlation between the
skin symptoms of atopic dermatitis and generalised anxiety. The aim of the study is to evaluate the effect of individualised homoeopathic treatment in
patients of atopic dermatitis associated with generalised anxiety. Patients who are suffering from atopic
dermatitis and registered in the OPD and IPD of National Institute of
Homoeopathy and fulfilling the inclusion and exclusion criteria will be taken
as sample of this study. The period of the study is 12 months; each patient will be followed
up for consecutive 6 months after inclusion in the study. Scoring for generalised anxiety using Generalised Anxiety Disorder (GAD-7)
score will be done at the first visit(baseline) and at the end of 6
months. |