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CTRI Number  CTRI/2024/05/067089 [Registered on: 09/05/2024] Trial Registered Prospectively
Last Modified On: 08/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   To Confirm the Beneficial Effects of Homoeopathic Medicines in the cases of Atopic Eczema with ‘Eczema Area and Severity Index’ (EASI – SCORE). 
Scientific Title of Study   To Verify The Effectiveness Of Homoeopathic Medicines In The Cases Of Atopic Eczema With The Aid Of ‘EASI – Score’ – A Clinical 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  Ritu A Lalwani  
Designation  PG Scholar 
Affiliation  Rajkot Homoeopathic Medical College 
Address  Rajkot Homoeopathic Medical College Department of Homoeopathic Materia Medica B/h Jainath Petrol Pump Gondal Road Rajkot

Rajkot
GUJARAT
360007
India 
Phone  6356880002  
Fax    
Email  lalwaniritu1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajesh Sanja 
Designation  HOD (Department of Homoeopathic Materia Medica) 
Affiliation  Rajkot Homoeopathic Medical College 
Address  Rajkot Homoeopathic Medical College Department of Homoeopathic Materia Medica Behind Jainath Petrol Pump Gondal Road Rajkot

Rajkot
GUJARAT
360002
India 
Phone  9825885350  
Fax    
Email  drrajeshsanja@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ritu A Lalwani 
Designation  PG Scholar 
Affiliation  Rajkot Homoeopathic Medical College 
Address  Rajkot Homoeopathic Medical College Department of Homoeopathic Materia Medica B/h Jainath Petrol Pump Gondal Road Rajkot

Rajkot
GUJARAT
360007
India 
Phone  6356880002  
Fax    
Email  lalwaniritu1997@gmail.com  
 
Source of Monetary or Material Support  
Sainath Homoeopathic Hospital attached with Rajkot Homoeopathic Medical College B/h Jainath Petrol Pump Gondal Road Rajkot Gujarat - 360002 
 
Primary Sponsor  
Name  Ritu A Lalwani 
Address  Rajkot Homoeopathic Medical College Department of Homoeopathic Materia Medica B/h Jainath Petrol Pump Gondal Road Rajkot Gujarat - 360002 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ritu A Lalwani  Sainath Homoeopathic Hospital  Rajkot Homoeopathic Medical College Department of Homoeopathic Materia Medica Behind Jainath Petrol Pump Gondal Road Rajkot
Rajkot
GUJARAT 		 6356880002

lalwaniritu1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Human Research - Rajkot Homoeopathic Medical College, Parul University   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic Medicine to each patient.  Individualized Homoeopathic Medicines are selected on the basis of Totality of Symptoms with the aid of Repertory and Homoeopathic Materia Medica. Mode of Administration - Oral (Sublingual). Selection of Potency, Dose and Repetition - Individualized Medicines will be prescribed in various potencies like 30, 200, 1M, etc. according to Susceptibility of the patients and Principles of Organon of Medicine. 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  20.00 Year(s)
Gender  Both 
Details  Patients within the age limit of 0 – 20 years will be included.
Both the sexes – Male and Female will be included.
Patients irrespective of their caste, religion and socio-economic condition.
Pre-diagnosed cases of AE or newly added cases fulfilling Hannifin and Rajika Criteria. 
 
ExclusionCriteria 
Details  Patients above 20 years of age.
Pregnant and Lactating mothers.
Patients with other systemic illness or serious pathological condition.
Patients taking other therapeutic measures for AE or any other diseases. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Ascertain the Effectiveness of Homoeopathic Medicines in the Cases of Atopic Eczema Diagnosed by ‘Hanifin And Rajika Criteria’ with ‘Eczema Area And Severity Index’ (EASI – Score) which will prove the hypothesis using paired t-test.  In each individual case, at the end of 3 months which can have 6 follow-ups at the interval of 15 days - the effectiveness is calculated with the help of EASI - Score. Also, all the cases will be statistically looked over to prove the effectiveness of Homoeopathic medicines in the cases of Atopic Eczema. 
 
Secondary Outcome  
Outcome  TimePoints 
To ascertain the utility of Homoeopathic Medicines in the Management of Atopic Eczema with the help of “EASI – Score”.
To evaluate the therapeutic value of various Homoeopathic Medicines in the treatment of Atopic Eczema.
To study the severity of spread of Atopic Eczema in different body regions.
To study the severity extent (in area) of Atopic Eczema in different body regions. 		 All these comparisons of spread & extent can be evaluated in the duration of 3 months with the changes seen in follow-ups in Individual cases.
Hence, based on individual study, generalized idea of spread & extent of Atopic Eczema can be reviewed in the duration of 12 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   N/A 
Date of First Enrollment (India)   20/05/2024 
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 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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [lalwaniritu1997@gmail.com].

  6. For how long will this data be available start date provided 01-06-2024 and end date provided 01-06-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - No any
Brief Summary  
STUDY SETTINGS –
  • The patients will be selected from OPDs, and Peripheral OPDs and organized Camps of Sainath Homoeopathic Hospital of Rajkot Homoeopathic Medical College.
STUDY DURATION –
  • Total duration of the study will be 12 months.
  • The registration for the first time screening, case taking and processing will be conducted up to 6 to 7 months after initiating the research process.
  • Whereas, on an average 4 to 6 follow ups will be noted with the duration interval of 15 days (based on individual case).
MATERIAL UTILIZED FOR THE STUDY –
  • Informed consent i.e. to be signed by every patient.
  • A specialized designed Case taking Proforma. (Note - All the records, forms and reports of the patient will be kept confidential.)
  • EASI Score Sheet (Form A and Form B).
  • Suitable Materia Medica for final selection of medicine.
  • Synthesis Repertory (RADAR 10.5.003) for Repertorization of cases.
  • The medicines will be obtained from genuine Homoeopathic pharmacy and dispensed by Dispensary of Sainath Homoeopathic Hospital.
METHODS OF COLLECTION OF DATA –
  • Type of Study - Qualitative, Experimental, Clinical, Prospective.
  • Sample Size - 40 cases (Cluster Proportional Sampling).
  • Selection of Cases - Random selection of cases based on the criteria’s of Sainath Homoeopathic Hospital attached with Rajkot Homoeopathic Medical College.
  • Statistical Methods - Data analysis, descriptive statistics and the results will be presented by using frequency table, percentage, diagrams, and graphs. The significance of treatment will be tested using paired t test.
INCLUSION CRITERIA –
  • Patients within the age limit of 0 to 20 years will be included.
  • Both the sexes will be included.
  • Patients irrespective of their caste, religion and socio-economic condition.
  • Pre-diagnosed cases of AE or newly added cases fulfilling Hannifin and Rajika Criteria.
EXCLUSION CRITERIA –
  • Patients above 20 years of age.
  • Pregnant and Lactating mothers.
  • Patients with other systemic illness or serious pathological condition.
  • Patients taking other therapeutic measures for AE or any other diseases.
WITHDRAWL CRITERIA –
  • If patient is not benefitting from the treatment, then patients can withdraw.
  • If the disease is worsening or leads advancing conditions, then physician can withdraw.
DROP – OUT CRITERIA –
  • Cases with no follow ups.
  • Cases without proper follow ups (at least 3 irregular follow - ups).
INTERVENTION –
  • The selection of Individualized Homoeopathic Medicine will be on the Totality of Symptoms for each case as their similimum.
  • The selection of Potency, dose and repetition will be on the basis of Susceptibility of the patient.
CASE – TAKING –
  • Case Taking will be done according to guidelines mentioned by Dr. Hahnemann in aphorisms 83 to 104 and specially designed format for the study.
CASE RECORD –
  • All the data will be recorded in Standardized case record with the following steps 
        1. Case taking.
        2. Recording and interpretation.
        3. Analysis of the case.
        4. Synthesizing the case.
        5. Erecting totality.
        6. Repertorization.
  • The higher matched and graded medications in the repertorized chart will be analysed and then validated from Homoeopathic Materia Medica to arrive at the prescription.
SOURCE BOOKS –
  • Proper Source books, journals, Repertories, monograms and Homoeopathic Software’s like Radar 10.5.003, and others, etc. will be utilized for studies.
SELECTION OF MEDICINE –
  • Selection of medicine in each case will be based on the data such as Etiological factors, Qualified Mental, Physical Generals, Concomitants, Characteristic Particulars, Repertorial approach and clinical indications from different authorities.
SELECTION OF POTENCY –
  • In each case Suitable Potency will be selected according to demand of the case based on Homoeopathic principles, with consideration of potency selection criteria such as Acute or Chronic, Susceptibility, Vitality and Suppression (if any), changes in structural and functional level and the degree of correspondence to the remedies.
DOSE & REPETITION –
  • Dose and Repetition of remedy will be done according to Homoeopathic principles laid down in Organon of Medicine.
ROUTE OF ADMINISTRATION OF MEDICINE –
  • All the medicines will be administrated through oral route.
FOLLOW UP AND MONITORING –
  • The follow up of cases will be done up to 4 to 6 follow ups every 15 days.
RECORDS –
  • All the records will be maintained as per standard procedure of institution.
OUTCOME ASSESSMENT –
  • Effectiveness of the treatment was assessed on the basis of –
    1. Clinical improvement – Disappearance or relief of symptoms, improvement in general health and reduction in area spread.
    2. For the effective assessment and evaluation, disease intensity scores will also be maintained according to EASI - Score(23).
EXPECTED OUTCOME –
  • The cases of AE will be analyzed for result on the basis of following criteria’s –
    1. Significant Improvement – Patients with sense of well-being without complaints and no relapse of symptoms.
    2. Moderate Improvement – Patients who will have partial relief in symptoms will decrease in area and spread of AE.
    3. Mild Improvement – Patients who will have symptomatic amelioration without any change in area and spread of AE.
    4. Status Quo – Patients remain in as it is condition even after administration of similimum Homoeopathic Medicine.
ASSESSMENT CRITERIA –
  • The Eczema Area and Severity Index (EASI) is a verified scoring system that employs a standardised procedure to assess the severity of atopic dermatitis symptoms and the area of skin involvement. The severity score is also recorded for each region of the body. It is calculated as the sum of the intensity score using 4 different signs. These 4 signs include –
      1. Scratching and excoriation.
      2. Redness of skin.
      3. Thickness of skin.
      4. Lichenification.
STEPS –
  1. To calculate the severity, the intensity of each 4 signs for all 4 regions separately is recorded.
  2. S𝐞𝐯𝐞𝐫𝐢𝐭𝐲 S𝐜𝐨𝐫𝐞 = 𝐈𝐧𝐭𝐞𝐧𝐬𝐢𝐭𝐲 𝐨𝐟(S𝐜𝐫𝐚𝐭𝐜𝐡𝐢𝐧𝐠+𝐓𝐡𝐢𝐜𝐤𝐧𝐞𝐬𝐬+R𝐞𝐝𝐧𝐞𝐬𝐬+𝐋𝐢𝐜𝐡𝐞𝐧𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧)
  3. For each region, multiple the area score by the severity score and by a multiplier (Note that the multiplier is different for each of the body region and is also different in children).
a) Head & Neck – Severity score x area score x 0.1 (in children from 0–8 yrs. the multiplier is 0.2)
b) Trunk – Severity score x area score x 0.3
c) Upper limbs – Severity score x area score x 0.2
d) Lower limbs – Severity score x area score x 0.4 (in children from 0–8 yrs. the multiplier is 0.3)
4. To determine the final EASI score, add up the total scores for each region. The minimum EASI score is 0. The maximum EASI score will be 72.

0 – 25% - No Improvement.
26 – 50% - Mild Improvement.
51 – 75% - Moderate Improvement.
75 – 100% - Significant Improvement.
 
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