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CTRI Number  CTRI/2024/12/077605 [Registered on: 03/12/2024] Trial Registered Prospectively
Last Modified On: 05/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Homeopathic treatment of dandruff 
Scientific Title of Study   Efficacy of individualized homoeopathic medicines in the treatment of seborrheic dermatitis in adults: A double-blind, randomized, placebo-controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1316-0975  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mukta Jain 
Designation  Postgraduate Trainee 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Dept. of Practice of Medicine, OPD room no. PG5 (Medicine) and 9 (Dermatology), 12, Gobinda Khatick Road

Kolkata
WEST BENGAL
700046
India 
Phone    
Fax    
Email  muktajain1370@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sumana Sengupta 
Designation  Lecturer 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Dept. of Practice of Medicine, OPD room no. PG5 (Medicine), 12, Gobinda Khatick Road

Kolkata
WEST BENGAL
700046
India 
Phone  9748192242  
Fax    
Email  sumanaseng@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sumana Sengupta 
Designation  Lecturer 
Affiliation  D N De Homoeopathic Medical College and Hospital 
Address  Dept. of Practice of Medicine, OPD room no. PG5 (Medicine), 12, Gobinda Khatick Road

Kolkata
WEST BENGAL
700046
India 
Phone  9748192242  
Fax    
Email  sumanaseng@gmail.com  
 
Source of Monetary or Material Support  
D N De Homoeopathic Medical College and Hospital 12 Gobinda Khatick Road Kolkata 700046 
 
Primary Sponsor  
Name  D N De Homoeopathic Medical College and Hospital 
Address  12 Gobinda Khatick Road Kolkata 700046 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mukta Jain  D N De Homoeopathic Medical College and Hospital  Dept of Practice of Medicine OPD no. 9 Skin and 1 PG5 Medicine 12 Gobinda Khatick Road Kolkata 700046
Kolkata
WEST BENGAL 		 9804559708

muktajain1370@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of D N De Homoeopathic Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L21||Seborrheic dermatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Identical looking placebo plus concomitant care  This arm will receive placebo that is visually identical to the active treatment. Each placebo dose will consist of 4 globules (no. 40) of cane sugar, moistened with rectified spirit, to be taken orally on an empty stomach with a clean tongue. The dosage and frequency will be adjusted based on individual requirements. Management guidelines will be the same as for the experimental arm. Both the medicines and placebos will be repackaged in identical glass bottles, each labeled with a code, the name of the medicine, and its potency. They will be dispensed according to a random number list. Concomitant care measures include hygiene maintenance, stress management, avoidance of personal triggers and dietary modification. Dose: Individualized. Frequency: Individualized. Route of administration: per oral. Treatment duration: 3 months. 
Intervention  Individualized homeopathic medicines in individualized dosage plus concomitant care  The intervention involves administering indicated homeopathic medicines in centesimal potencies (CH). Each dose will comprise 4 cane sugar globules (no. 40) moistened with the prescribed medicine (preserved in 90% v/v ethanol), to be taken orally on an empty stomach with a clean tongue. The dosage and frequency will be tailored to each individuals needs. Patients will be instructed to avoid handling the globules and to refrain from eating, drinking, smoking, or brushing their teeth for 30 minutes after taking the globules. They will also be advised to suck the globules rather than swallowing them whole. On each occasion, a single individualized medicine will be prescribed based on the totality of presenting symptoms, clinical history, constitutional features, miasmatic expressions, repertorization (using HOMPATH and RADAR software if necessary), and with input from Materia Medica and consensus among three homeopaths. All medicines and related items will be sourced from a Good Manufacturing Practice (GMP) certified supplier. Concomitant care measures include hygiene maintenance, stress management, avoidance of personal triggers and dietary modification. Dose: Individualized. Frequency: Individualized. Route of administration: per oral. Treatment duration: 3 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients suffering from seborrheic dermatitis. The diagnosis will be based upon recognizing folliculocentric lesions or erythematous plaques with yellow, greasy scales, and their typical distribution in seborrheic areas.
2. Age between 18 and 65 years.
3. Participants of either sex or transgender.
4. Patient’s ability to understand English/ Hindi/ Bengali.
5. Diagnosed cases of mild and moderate seborrheic dermatitis (ICD 11- EA81) (For scalp: EA81.1, For face: EA81.0) as per International Classification of Diseases for Mortality and Morbidity Statistics, 11th Revision, v2024-01.
6. Patients not taking any allopathic treatment or using topical agents for seborrheic dermatitis from past 2 weeks will be included in the study. 
 
ExclusionCriteria 
Details  1. Not providing with written informed consent of participation.
2. Patients suffering from severe form of seborrheic dermatitis or having super-added bacterial or candidal infection.
3. Patients who are too sick for consultation.
4. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled systemic illness or life-threatening condition, affecting quality of life.
5. Pregnancy, puerperal women and lactating mothers
6. Tobacco chewing and/or smoking, alcoholism and/or any form(s) of substance abuse and/or dependence (TAPS tool).
7. Self-reported immune-compromised state, AIDS, hepatitis etc.
8. Undergoing homoeopathic treatment for any chronic disease within last 3 months.
9. Simultaneous participation in any other clinical trial. 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Scalpdex: A quality of life instrument for scalp dermatitis  Baseline, and every month, up to 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
SEborrheic Dermatitis Area and Severity Index (SEDASI)  Baseline, and every month, up to 3 months 
Measure Yourself Medical Outcome Profile v.2 (MYMOP-2)  Baseline, and every month, up to 3 months 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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/ Phase 3 
Date of First Enrollment (India)   16/12/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [muktajain1370@gmail.com].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Seborrheic dermatitis is a common chronic, non-infectious, recurrent inflammatory disease of the skin that affects about 1-5% of the global population. In Indian adults with scalp dermatoses, 18.7% of cases were attributed to seborrheic dermatitis. It has been associated with overproduction of sebum and Malassezia yeast species and is manifested by greasy, scaly reddish-brown itchy patches in sebaceous, gland-rich regions of the scalp, face, and trunk affecting the quality of life of the patients. Homeopathy may have immense potential to offer in successful treatment of seborrheic dermatitis, however, the research evidence is limited. This 3-months, double-blind, randomized, placebo controlled trial is aimed at evaluating the efficacy of homeopathic medicines in the treatment of seborrheic dermatitis in 54 adults. The primary outcome measure is Scalpdex; the secondary outcomes are SEDASI, MYMOP-2 questionnaires, all measured at baseline, and every month, up to 3 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals. 
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