| CTRI Number |
CTRI/2025/10/095833 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
STUDY ON THE EFFECTIVENESS OF CONSTITUTIONAL HOMEOPATHIC MEDICINE IN ECZEMA ( AGE 15-55 YEARS ) USING THE EASI SCALE |
|
Scientific Title of Study
|
“A PROSEPCTIVE CLINICAL STUDY TO ASSESS THE EFFECTIVENESS OF CONSTITUTIONAL HOMEOPATHIC MEDICINE IN CASES OF ECZEMA BETWEEN THE AGE OF 15-55 YEARS OF
BOTH SEX BY USING THE ECZEMA AREA AND SEVERITY INDEX (EASI) SCALE” |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KANZARIYA NAVIN BHUPATBHAI |
| Designation |
MD SCHOLAR |
| Affiliation |
RAJKOT HOMEOPATHIC MEDICAL COLEGE |
| Address |
DIYAL KRUPA ,NEAR SHAKTIPARA ,LAXMINAGAR , BOTAD , BOTAD BEHIND JAINATH COMPLEX , NEAR MAKKAM CHOWK , GONDAL ROAD , RAJKOT , 360002 , GUJARAT , INDIA Rajkot GUJARAT 364710 India |
| Phone |
9081006186 |
| Fax |
|
| Email |
NBKANZARIYA005@GMAIL.COM |
|
Details of Contact Person Scientific Query
|
| Name |
DR HITARTH MEHTA |
| Designation |
HEAD OF THE DEPARTMENT PRACTICE OF MEDICINE |
| Affiliation |
RAJKOT HOMEOPATHIC MEDICAL COLLEGE |
| Address |
A/32 OSCAR RESIDENCY , 150 FEET RING ROAD , BEHIND STERLING HOSPITAL , RAJKOT , GUJRAT BEHIND JAINATH COMPLEX , NEAR MAKKAM CHOWK , GONDAL ROAD , RAJKOT , 360002 , GUJRAT , INDIA Rajkot GUJARAT 360007 India |
| Phone |
9825340073 |
| Fax |
|
| Email |
HITARTH.MEHTARHMC@PARULUNIVERSITY.AC.IN |
|
Details of Contact Person Public Query
|
| Name |
KANZARIYA NAVIN BHUPATBHAI |
| Designation |
MD SCHOLAR |
| Affiliation |
RAJKOT HOMEOPATHIC MEDICAL COLLEGE |
| Address |
DIYAL KRUPA , NEAR SHAKTIPARA , LAXMINAGAR , BOTAD , BOTAD BEHIND JAINATH COMPLEX , NEAR MAKKAM CHOWK , GONDAL ROAD , RAJKOT , 360002 , GUJARAT , INDIA Rajkot GUJARAT 364710 India |
| Phone |
9081006186 |
| Fax |
|
| Email |
NBKANZARIYA005@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| RAJKOT HOMEOPATHIC MEDICAL COLLEGE |
|
|
Primary Sponsor
|
| Name |
SAINATH HOSPITAL |
| Address |
BEHIND JAINATH COMPLEX , NEAR MAKKAM CHOWK, GONDAL ROAD , RAJKOT , 360002, GUJARAT , INDIA |
| 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 |
| KANZARIYA NAVIN BHUPATBHAI |
SAINATH HOMEOPATHIC HOSPITAL |
101, DEPARTMENET OF MEDICINE , BEHIND JAINATH COMPLEX , NEAR MAKKAM CHOWK , GONDAL ROAD , RAJKOT , 360002 , GUJARAT , INDIA Rajkot GUJARAT |
9081006186
NBKANZARIYA005@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH - RAJKOT HOMEOPATHIC MEDICAL COLLEGE [RHMC] , PARUL UNIVERSITY |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
“A PROSEPCTIVE CLINICAL STUDY TO ASSESS THE EFFECTIVENESS OF CONSTITUTIONAL HOMEOPATHIC MEDICINE IN CASES OF ECZEMA BETWEEN THE AGE OF 15-55 YEARS OF BOTH SEX BY USING THE ECZEMA AREA AND SEVERITY INDEX (EASI) SCALE” |
Eczema is a chronic, relapsing inflammatory skin disorder characterized by itching, redness, dryness, and lichenification, often causing considerable psychosocial distress. Conventional treatments such as corticosteroids and immunosuppressants may provide temporary relief but are associated with side effects and frequent relapses. Homeopathy, with its constitutional and holistic approach, aims to treat the individual as a whole, addressing not only the skin but also the mental and emotional spheres. This study seeks to scientifically evaluate the effectiveness of constitutional homeopathic medicines in eczema cases using the Eczema Area and Severity Index (EASI) as the assessment tool.
This prospective, clinical, interventional study will include 50 patients of both sexes aged 15–55 years, diagnosed with eczema. Case-taking will be performed as per Hahnemann’s guidelines (Organon aphorisms 83–104), followed by repertorization and prescription of individualized constitutional remedies. Patients will be followed up every 15 days for 12 months, and progress will be measured using the EASI scale. Data will be statistically analyzed using the chi-square test.
The study aims to provide evidence on the role of constitutional homeopathy in improving the severity and extent of eczema, potentially offering a safe, effective, and holistic alternative to conventional therapy. By using a standardized scoring system, this research intends to bridge traditional homeopathic practice with objective clinical assessment. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
clinically diagnosed patients eczema based on EASI scale , both sex , between age of 15-55 , willing and able to give written informed consent |
|
| ExclusionCriteria |
| Details |
Pt suffering from another skin diseases like psoriasis , lichen planus , tinea , bacterial and viral infections
Autoimmune markers positive — suggests lupus or other autoimmune skin conditions.
Presence of systemic symptoms (like fever, weight loss) — might indicate more serious conditions.
Participants in another intervational study within the last 3 months.
Presence of serious comorbidities (eg. Malignancy , uncontrolled diabetes , severe cardiac disease.
pregnant or lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Eczema Area and Severity Index score from baseline to the end of the treatment.
This measures the effectiveness of constitutional homeopathic medicine in reducing eczema severity. |
Change in Eczema Area and Severity Index score from baseline to the end of the treatment.
This measures the effectiveness of constitutional homeopathic medicine in reducing eczema severity. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Improvement in patient-reported symptoms using a Visual Analog Scale
2. Improvement in quality of life assessed by Dermatology Life Quality Index or similar questionnaire.
3. Safety and tolerability of constitutional homeopathic medicine |
At 4 weeks, 8 weeks, and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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 1 |
|
Date of First Enrollment (India)
|
22/10/2025 |
| 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="11" Days="29" |
|
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
|
Eczema is a chronic, relapsing inflammatory skin disorder characterized by itching, redness, dryness, and lichenification, often causing considerable psychosocial distress. Conventional treatments such as corticosteroids and immunosuppressants may provide temporary relief but are associated with side effects and frequent relapses. Homeopathy, with its constitutional and holistic approach, aims to treat the individual as a whole, addressing not only the skin but also the mental and emotional spheres. This study seeks to scientifically evaluate the effectiveness of constitutional homeopathic medicines in eczema cases using the Eczema Area and Severity Index (EASI) as the assessment tool.
This prospective, clinical, interventional study will include 50 patients of both sexes aged 15–55 years, diagnosed with eczema. Case-taking will be performed as per Hahnemann’s guidelines (Organon aphorisms 83–104), followed by repertorization and prescription of individualized constitutional remedies. Patients will be followed up every 15 days for 12 months, and progress will be measured using the EASI scale.
The study aims to provide evidence on the role of constitutional homeopathy in improving the severity and extent of eczema, potentially offering a safe, effective, and holistic alternative to conventional therapy. By using a standardized scoring system, this research intends to bridge traditional homeopathic practice with objective clinical assessment. |