| CTRI Number |
CTRI/2025/08/092664 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the effects of homoeopathic treatment on symptoms and quality of life in patients with eczema. |
|
Scientific Title of Study
|
Effectiveness of individualized homoeopathic treatment on quality of life and clinical symptoms in eczema |
| 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 ANGELA B WILLIAMS |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Sarada krishna homoeopathic medical college |
| Address |
Room no 403, IIIrd floor, college building, Department of organon of medicine, sarada krishna homoeopathic medical college, Kulasekharam, Kanniyakumari district, Tamilnadu.
Kanniyakumari TAMIL NADU 629161 India |
| Phone |
8281829766 |
| Fax |
|
| Email |
angelabwilliams766@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr MANOJ NARAYAN V |
| Designation |
PROFESSOR |
| Affiliation |
Sarada krishna homoeopathic medical college |
| Address |
Room no 403, IIIrd floor, College Building, Department of Organon of Medicine,
Sarada Krishna Homoeopathic Medical College, Kulasekharam,
Kanniyakumari district, Tamilnadu. Room no 403, IIIrd floor, College Building, Department of Organon of Medicine,
Sarada Krishna Homoeopathic Medical College, Kulasekharam,
Kanniyakumari district, Tamilnadu. Kanniyakumari TAMIL NADU 629161 India |
| Phone |
9995114518 |
| Fax |
|
| Email |
manojnarayanv@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr MANOJ NARAYAN V |
| Designation |
PROFESSOR |
| Affiliation |
Sarada krishna homoeopathic medical college |
| Address |
Room no 403, IIIrd floor, College Building, Department of Organon of Medicine,
Sarada Krishna Homoeopathic Medical College, Kulasekharam,
Kanniyakumari district, Tamilnadu.
Kanniyakumari TAMIL NADU 629161 India |
| Phone |
9995114518 |
| Fax |
|
| Email |
manojnarayanv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sarada krishna homoeopathic medical
college, Kulasekharam, Kanniyakumari
district, Tamilnadu,India 629161 |
|
|
Primary Sponsor
|
| Name |
Post graduate research funded by college |
| Address |
Sarada krishna homoeopathic medical college, Kulasekharam,
Kanniyakumari district, Tamilnadu.629161 |
| 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 |
| Dr ANGELA B WILLIAMS |
Sarada Krishna Homoeopathic Medical College |
Room no 403, IIIrd floor, Department of Organon, Opd, Ipd, Rural Health Centres, Sarada Krishna Homoeopathic
Medical College, Kulasekharam,
Kanniyakumari, TamilNadu,629161.
Kanniyakumari TAMIL NADU |
8281829766
angelabwilliams766@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee sarada krishna homoeopathic medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L20-L30||Dermatitis and eczema, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Similimum based on individualized homoeopathic principle in eczema. |
Case taking, selection and administration of medicine will be based on Homoeopathic principles. Homoeopathic similar remedy is prescribed for the totality of symptoms erected based on individualization. The pre-assessment is conducted during the initial visit, followed by regular follow-up every 14 days. The cases are being observed over a period of 6 months. Post-assessments will be done at the end of 3 months and again at the end of 6 months using the DLQI and EASI. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 16 years to 65 years.
Both sexes.
Patients of all socioeconomic types. |
|
| ExclusionCriteria |
| Details |
Pregnant and Lactating women.
Patients with serious systemic illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the quality-of-life improvement in patients with eczema, as measured by the dermatology life quality index (DLQI), with homoeopathic medications. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the reduction in severity of symptoms of eczema with homoeopathic medicines. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="28" Sample Size from India="28"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Eczema
is a skin condition that extends beyond physical symptoms, causing emotional
distress, social stigma, and impacts on daily life, including career and
personal relationships. The prevalence of Eczema ranged from 0.98% to 9.2% in
studies including paediatric and adult patients. The cost of medications was
reported to be the major contributor to the economic burden associated with
Eczema. This prospective study aims to
evaluate the effectiveness of individualized homoeopathic treatment on the
quality of life and symptom severity in patients diagnosed with Eczema. A total
of 28 patients, aged between 16 to 65 years and of both sexes, will be enrolled
from the Outpatient Department (OPD), Inpatient Department (IPD), and
affiliated rural health centres of Sarada Krishna Homoeopathic Medical College.
Each patient will undergo a thorough case-taking process, and homoeopathic
medicines will be prescribed based on the totality of symptoms. The primary
outcome measures for the study include the Dermatology
Life Quality Index (DLQI), a validated tool to assess the impact of skin
diseases on patients’ daily lives, and the Eczema Area
Severity Index (EASI), which is employed to objectively measure the
severity of eczema symptoms. The pre-assessment is conducted during the initial
visit, followed by regular follow-up every 14 days. The cases are being
observed over a period of 6 months. Post-assessments will be done at the end of
3 months and again at the end of 6 months using the DLQI and EASI. All relevant
clinical data and patient responses will be systematically documented
throughout the study. This study aims to provide observational evidence on the
role of individualised homoeopathic treatment in managing eczema and improving
patients’ quality of life, thereby contributing to integrative dermatological
care. The outcomes may support further research into the potential benefits of
homoeopathy in chronic dermatological conditions. |