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CTRI Number  CTRI/2024/12/078674 [Registered on: 27/12/2024] Trial Registered Prospectively
Last Modified On: 27/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Scope Of Homoeopathy In Dandruff 
Scientific Title of Study   Scope Of Homoeopathy In Seborrheic Dermatitis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dipti Amrutlal Mevada 
Designation  MD Scholar Part 2 
Affiliation  C D Pachchigar College of Homoeopathic Medicine And Hospital 
Address  Department of Practice of Medicine Division of MD 2nd floor C D Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
C D Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
Surat
GUJARAT
395001
India 
Phone  8980212633  
Fax    
Email  diptimevada912@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sameer S Upadhyay 
Designation  HOD in Practice of medicine 
Affiliation  C D Pachchigar College of Homoeopathic Medicine And Hospital 
Address  Department of Practice of Medicine Division of MD 2nd floor C D Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
C D Pachchigar College of Homoeopathic Medicine And Hospital Surat
Surat
GUJARAT
395001
India 
Phone  9426836991  
Fax    
Email  drsameerupadhyay@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dipti Amrutlal Mevada 
Designation  MD Scholar Part 2 
Affiliation  C D Pachchigar College of Homoeopathic Medicine And Hospital 
Address  Department of Practice of Medicine Division of MD 2nd floor C D Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
C D Pachchigar College of Homoeopathic Medicine And Hospital Surat

GUJARAT
395001
India 
Phone  8980212633  
Fax    
Email  diptimevada912@gmail.com  
 
Source of Monetary or Material Support  
C.D. Pachchigar College of Homoeopathic Medicine And Hospital, near Anand Mangal society, Bhatar road, Surat-395001 
 
Primary Sponsor  
Name  C.D. Pachchigar College of Homoeopathic Medicine And Hospital 
Address  near Anand Mangal society, Bhatar road, Surat-395001 
Type of Sponsor  Private medical college 
 
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 
Dipti Amrutlal Mevada  C D Pachchigar College of Homoeopathic Medicine and Hospital  Department of Practice of Medicine Division of MD 2nd floor C D Pachchigar College of Homoeopathic Medicine and Hospital Surat 395001 Gujarat
Surat
GUJARAT 
8980212633

diptimevada912@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Of C D Pachchigar College of Homoeopathic Medicine and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L219||Seborrheic dermatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Medicine  Homoeopathic Medicine as per requirement of case through oral route administration within time duration of 9 months 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patient from- both the sex, all socioeconomic class, and age group up to 50 years will be included.
Pre diagnosed cases of seborrheic dermatitis by dermatologist.
Cases which are diagnosed clinically according to history and sign and symptoms.
 
 
ExclusionCriteria 
Details  Patients with very severe seborrheic dermatitis, according to SEDASI score more than 45.
Patients with any other co morbid complain.
Patient with irregular follow up.
Patient on other mode of treatment for seborrheic dermatitis
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Removal of symptoms of Seborrhiec Dermatitis  9 months 
 
Secondary Outcome  
Outcome  TimePoints 
To relief from recurrent tendency of Seborrheic Dermatitis  as per requirement of cases 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   07/01/2025 
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="9"
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  

6

 BRIEF  RESUME  OF  INTENDED  WORK:

6.1

 NEED  FOR  STUDY:

Skin disease is most common diseases of recent times. Skin diseases that alter skin complexion or color, texture, or appearance in any way induce negative emotions in others. So person suffering from skin disease has to face social stigma, and that leads to isolation.

 

Seborrheic dermatitis has been reported to affect approximately 1-5% of the population worldwide. Seborrheic dermatitis was ranked as the third most troublesome skin disease after atopic dermatitis and tinea cruris. A study in India reported that 13.4% of children aged <5 years had Seborrheic dermatitis, with the prevalence peaking during infancy and decreasing steadily with age. In Indian adults with scalp dermatoses, 18.7% of cases were attributed to Seborrheic dermatitis (1).

 

Infants are not usually troubled by seborrheic dermatitis, but it may cause significant parental anxiety, often appearing as firm, greasy scales on the crown and frontal regions of the scalp. It occurs in the first three months of life and is mild, self-limiting, and resolving spontaneously in most cases by the first year of life. Adult seborrheic dermatitis, on the other hand, is characterized by a relapsing and remitting pattern of disease and it has the potential to impair the quality of life.

 

Seborrheic Dermatitis affects all ethnic groups in all regions globally. Most of the time, the illness is not fatal, but it can result in anxiety, lack of confidence, and social problems, especially among adults in this competitive era. Hence, affecting overall health by disturbing physical as well as mental health and needs medical attention.

 

Homeopathy, rooted in the foundational principles of "Similia similibus curentur" and a holistic approach, represents a unique paradigm in healthcare. The Latin phrase translates to "like cures like," conveying the core idea that a substance capable of producing certain symptoms in a healthy person can, in small doses, treat similar symptoms in someone who is unwell. This guiding principle distinguishes homeopathy from conventional medicine, focusing on an individualized approach that considers not only the physical symptoms but also the patient’s mental and emotional state. By treating the individual rather than the disease, homeopathy aims to stimulate the body’s inherent healing mechanisms. Thus it is the most effective way to treat seborrheic dermatitis.

 

 

6.2

 REVIEW  OF  LITERATURE:

 

 

 History

 

Seborrheic dermatitis was first described by Unna, who also suspected Malassezia furfur (Pityrosporum ovale) as a causative factor. The nosologic position of seborrheic dermatitis was widely discussed for decades, the focus resting on dysfunction of the sebaceous glands and the high amounts of M. furfur present in scales of seborrheic dermatitis. In 1984 it was shown that seborrheic dermatitis could be suppressed by systemic ketoconazole. This finding was corroborated by later studies, and it became clear that seborrheic dermatitis was strongly linked to Pityrosporum yeasts (2).

 

Definition

 

Seborrheic dermatitis is a common, chronic disorder characterized by greasy scales overlying erythematous patches or plaques (3).

Seborrheic dermatitis has often been studied under the heading of eczema, even though it has been separated from this group of diseases since its description by Paul Gerson Unna (1850–1929) in 1887 (4).

 

 Epidemiology

 

Seborrheic dermatitis is separated into two age groups, an infantile self-limited form primarily during the first 3 months of life and an adult form that is chronic.   A male predominance is seen in all ages. The prevalence of seborrheic dermatitis is 3%–5% of young adults, and 1%–5% of the general population (5).

 

 Etiology and pathogenesis

 

·      The exact pathogenesis of seborrheic dermatitis is yet to be fully elucidated, but this dermatosis is commonly linked with the yeast Malassezia (5).

·      The genus Malassezia consists of lipophilic yeasts that are part of the normal resident skin flora (2).

·      Disturbance in flora, lipase activity, and free oxygen radicals may be more closely linked to seborrheic dermatitis (5).

·      An increased secretion of lipases and phospholipases has been shown in vivo in patients with SD and this can lead to the formation of oleic acid, which impairs epidermal barrier function and causes desquamation of scalp skin as dandruff in susceptible individual.

·      Raised levels of cathepsin S and histamine have been identified in scalp samples from patients with SD/dandruff and may play a role in the pruritus that usually accompanies this complaint (6).

·      Genetic and environmental factor (6).

·      Although it is frequently seen in patients with Parkinson’s disease, in those who have had cerebrovascular accidents, and in those with HIV infection, the overwhelming majority of individuals with seborrheic dermatitis have no underlying disorder (3).

 

 Clinical presentation

 

Seborrheic dermatitis is defined by clinical parameters, including:

·      sharply demarcated patches or thin plaques that vary from pink–yellow to dull red to red–brown with bran-like to flaky “greasy” scales; vesiculation and crusting may occur but are rare and mostly due to irritation

·      a predilection for areas rich in sebaceous glands – scalp, face, ears (2).

·      On the face, seborrheic dermatitis affects the eyebrows, eyelids, glabella, and nasolabial folds. Scaling of the external auditory canal is common in seborrheic dermatitis. In addition, the postauricular areas often become macerated and tender. Seborrheic dermatitis may also develop in the central chest, axilla, groin, submammary folds, and gluteal cleft.

·      Rarely, it may cause widespread generalized dermatitis.

·      Pruritus is variable (3).

 

 Clinical variant

 

·         â€¢  Infantile seborrheic dermatitis

The infantile form occurs during the first few weeks to 3 months of life, is self-limited. It is commonly concentrated on the vertex of the scalp (i.e., cradle cap) with adherent, yellow–brown, greasy scale, which can sometimes spread to the entire scalp with inflammatory, erythematous, and oozing crusts. Lesions can be seen on the face, neck and can be disseminated to the trunk and extremities with inflammatory glistening plaques in intertriginous sites such as the axillae and groin.

 

  â€¢ Adult seborrheic dermatitis

The adult form on the other hand, tends to be chronic and can persist from the fourth through the seventh decades of life, with a peak at age 40.

Lesions may also be seen on the face with prominent symmetry, particularly medial eyebrows, forehead, upper eyelids, nasolabial folds, and lateral nares. Other sites commonly involved include retroauricular regions, external auditory canal, auricle, and, scalp, occiput, and neck. The presternal region of the chest, upper back and umbilicus can be involved as well (5).

 

- Blepharitis: Inflammation of the anterior eyelid margin may occur in SD and presents with flaky debris on the eyelashes.

 

- Petaloid pattern: In men, involvement of the presternal area is typical with petal‐shaped lesions that may be localized.

 

- The ‘pityriasiform’ variant of Seborrheic dermatitis comprises a generalized erythematosquamous eruption (6).

 

 Diagnosis

 

-The diagnosis is usually made on clinical grounds without the need for diagnostic tests.

-HIV testing

-Dermoscopy

-Histopathology (6)

 

 Differential diagnosis

 

-Atopic dermatitis

-Irritant diaper dermatitis

-Tinea capitis

-Pityriasis amiantacea

-Pityriasis rosea

-SLE (2)

-Scabies

-Psoriasis (5)

 

 Classification of severity

 

 The severity of Seborrheic Dermatitis and dandruff is highly variable.

·       A clinical score termed the seborrheic dermatitis area severity index (6,7).

·       Establishment of clinical evaluation criteria for scalp seborrheic dermatitis (SSD) (8).

 

 Complication

 

 Leiner’s disease (5)

Malassezia (Pityrsporum) folliculitis (2)

 

 Treatment

 

Treatment with low-potency topical glucocorticoids in conjunction with a topical antifungal agent, such as ketoconazole cream or ciclopirox cream, is often effective. The scalp and beard areas may benefit from antidandruff shampoos. High-potency topical glucocorticoid solutions (betamethasone or clobetasol) are effective for control of severe scalp involvement (3).

 

Homoeopathic approach

 

When an individual becomes sick, he becomes unwell overall not only part, so we have to look at all of his symptoms and treat as a whole. For that homoeopathic specific remedy as per the basic principle “Similia similibus curentur” should be searched.

 

As mentioned in § 217 -In homeopathy, a physician must carefully investigate the symptom totality to find a homoeopathic medicinal disease agent to remove disease, by considering physical, mental and emotional state of which express the individual as a whole (9).

 

As mentioned in § 118-Every medicine exhibits in the human body specific effects that do not occur from any other medicinal substance (9), exactly in the same manner individuals require specific remedies in treating the illness.

 

As mentioned in § 153- In search of homoeopathic specific remedy, close attention should be given to the more striking, strange, unusual, peculiar (characteristic) signs and symptoms in the case, because it is these above all which must correspond to very similar symptoms in the homoeopathic materia medica being searched, then remedy to be the one most suitable for the cure (9).

 

Some homoeopathic medicine can be used as therapeutic when indicated in case. The most serviceable internal remedies are the following:

 

·       Ammonium mur. -Large accumulation of bran- like scales, with falling off of the hair.

 

·       Mercurius sol.-Seborrhea of the genitals, accompanied with hyperemia.

 

·       NATRUM MUR. - Severe itching of the scalp. The hair falls out in masses. Seborrhea of the face.

 

·       Potassium(KALI) bromide. -Seborrhea on hairy portions of the face, forehead and neck.

 

·       Sepia -Seborrhea of the genitals in women.

 

·       Thuja -White scaly dandruff. Hair dry and falling off (10)

 

·       Graphites -Eruption exudes a transparent, glutinous fluid, which causes the crusts to fall off; then more form, to fall again in turn, eruption spreading more and more over a large surface.

 

·       Oleander -Eruption on scalp and back of ears, oozing a fluid and breeding vermin; chafing about neck or between scrotum and thighs.

 

·       Mezereum -Child scratches face continually, which becomes covered with blood; face and forehead red and hot, with great restlessness and peevishness; the ichor from the scratched face excoriates other parts; honey- like scab around mouth.

 

·       Psorinum -Moist, suppurating, fetid eruption, pustules and boils on scalp and head which look dirty and emit an offensive odor; hair lusterless, tangles easily.

 

·       Rhus tox. -A bright edge of inflammation surrounds every portion of the eruption, with much itching, particularly at night; eruption moist, suppurating, forming thick crusts, offensive itching; hair is eaten off; extends to shoulders; scalp sensitive, < on side not lain on, when growing warm in bed, from touch and combing hair back.

 

·       Viola tric-Burning and itching milk-crust, with discharge of tough yellow pus; exudation very copious; thick incrustations, pouring out copiously a thick yellow fluid, which agglutinates the hair; heat and perspiration of face after eating; urine of strong odor, like cat’s urine; during sleep hands twitch, thumbs are clenched, face is red and the whole body feels hot and dry, < at night (11).

 

6.3

 

 OBJECTIVE  OF  THE  STUDY:

 -To study seborrheic dermatitis, etio-pathology, various clinical presentations.

·       -To study the role of homoeopathy remedies in cases of seborrheic derma

 

 

 

 

 

 

 

 

 

 

 

 

 

 7

 material  and  methods:

 7.1

SOURCE OF DATA:

Project site: Chandravatiben Dhansukhlal Pachchigar College of Homoeopathic Medicine and Hospital – OPD and Periphery OPD allotted by institute.

 7.2

MATERIALS:

1.    Standard Case Format of Chandravatiben Dhansukhlal Pachchigar College of Homoeopathic Medicine and Hospital – OPD.

2.    Informed consent form of patient.

3.    Computerized homoeopathic software – CARA PRO version v 1.4, Synthesis by Dr. Frederik Schroyens, MD.

4.    Books: various books of allied science, Homoeopathic Materia medica, Organon of medicine and philosophy.

5.    Website and articles related to my topic.

6.    SEDASI SCALE assessment scale for seborrheic dermatitis (6,7),

SSD scale (8).

 7.3

 METHOD  OF  COLLECTION  OF  DATA:

The study will be performed in following ways:

1.    Study design – Experimental study.

2.    Study type – Prospective study.

3.    Study population – cases having complain of seborrheic dermatitis who treated with homoeopathic medicine at Chandravatiben Dhansukhlal Pachchigar college of homoeopathic medicine and hospital.

4.    Sample size – 30 cases.

5.    Sampling techniques-simple randomization.

6.    Selection criteria.

Inclusion criteria:

1.    Patient from- both the sex, all socioeconomic class, and age group up to 50 years will be included.

2.    Pre diagnosed cases of seborrheic dermatitis by dermatologist.

3.    Cases which are diagnosed clinically according to history and sign and symptoms.

 

Exclusion criteria:

1.    Patients with very severe seborrheic dermatitis, according to SEDASI score > 45. 

2.    Patients with any other co morbid complain.

3.    Patient with irregular follow up.

4.    Patient on other mode of treatment for seborrheic dermatitis.

 

v  Case Taking will be done as per the instructions given by Dr. Hahnemann in aphorisms 83-104 in Organon of Medicine.

v  Analysis & Evaluation of symptoms will be done for Totality formation.

v  Totality Formation will be done as per the instructions given by Dr. Hahnemann in Organon of Medicine.

v  Remedy will be selected on the basis of Totality of Symptoms.

     Selection of medicine will be done on the basis of reportorial as well as non repertorial approach depending upon the demand of the case.

v  Remedy will be administered in various potencies depending on the case. All the medicines will be administered through oral route.

v  Follow up of each case will be taken at interval of 7,15,21,30 days or as per requirement.

v  Homoeopathic Remedies will be dispensed from C.D. Pachchigar College & Hospital Homoeopathic pharmacy as per the guidelines of

Dr. Hahnemann advised in Organon of Medicine.

 

 

v  Response will be analysed in following way:

 

Assessment criteria: assessment of efficiency done on SEDASI Scale (6,7)                                             And SSD (8).

 

·       A clinical score termed the seborrheic dermatitis area severity index (6).

This severity scoring system is based on the evaluation of four facial regions, each representing approximately 25% of the entire face surface: nose (including nasolabial folds), forehead (including eyebrows and upper eyelids), left cheek (including lower eyelids, ear, and chin) and right cheek (including lower eyelids, ear, and chin).

 

 For each region, 4 items are considered:

1) extension of SD lesions expressed as percentage area of involvement

   (no visible lesions = 0; 1-9% = 1; 10-29% = 2; 30-49% = 3; 50-69% = 4;

   70-89% = 5; 90-100% = 6);

2)presentation pattern (no visible lesions = 0; few small scattered patches =1); multiple and/or clustered patches = 2; large and/or confluent patches = 3);

3) erythema degree (none = 0; pink = 1; pink-red = 2; intense red = 3);

4) scaling degree (none = 0; tiny scales = 1; medium-size thicker scales = 2; large, thickened scales = 3).

 

Total score may range from 0 (no SD) to 60 (SD of the worst possible degree). define face SEDASI score as follows:

       1-14 mild; 15-29 moderate; 30-44 severe; >45 very severe (7).

 

 

 

 

·       Establishment of clinical evaluation criteria for scalp seborrheic dermatitis (SSD)

A "16-point scale", consisting of items for adherent scalp flaking (0-10), maximum erythema area (0-3), and pruritus (0-3), was used to score the patients with SSD, and the total score was strongly correlated with and differentiated the severity of SSD.

Recommended evaluation criteria:

-       a total score of 0-5 points indicates mild SSD,

-       6-9 points indicates moderate SSD,

-       10-16 points indicates severe SSD.

These criteria can help to standardize disease diagnosis and treatment, and efficacy assessment (8).

 

7.4

 

DOES THE STUDY REQUIRING ANY INVESTIGATION TO BE

CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS?

 

Investigations will be done as and when required.

 

7.5

 

HAS ETHICAL CLEARANCE BEEN OBTAIN FROM YOUR INSTITUTE?

 

 

 

 

 Yes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   8

 BIBLIOGRAPHY:

 

 

x

1.

Cheong W, Yeung C, Torsekar R, Suh D, Ungpakor R, Widaty S, et al. Treatment of Seborrhoeic Dermatitis in Asia: A Consensus Guide. [Online].; 2016. Available from: https://pubmed.ncbi.nlm.nih.gov/27386464/PMID: 27386464; PMCID: PMC4908450.

2.

Bolognia J, Cerroni L, Schaffer J. Dermatology. 4th ed. Philadelphia: Elsevier; 2018.

3.

Loscalzo J, Fauci A, Kasper D, Hauser S, Longo D, Jameson J. Harrison’s principles of internal medicine. 21st ed. New York: McGraw Hill; 2022.

4.

Mameri L, Cunha J, Ramos-e-silva M. History of Seborrheic Dermatitis: Conceptual and Clinico-Pathologic Evolution. [Online].; 2017. Available from: https://www.researchgate.net/publication/318436321.

5.

Goldsmith L, Katz S, Gilchrest B, Paller A, Leffell D, Wolff K. Fitzpatrick’s dermatology in general medicine. 8th ed. New York: McGraw Hill; 2012.

6.

Griffiths C, Barker J, Bleiker T, Chalmers R, Creamer D. Rook’s Textbook of Dermatology. 9th ed.: Wiley Blackwell; 2016.

7.

Micali G, Lacarrubba F, Dall’Oglio F, Tedeschi A, Dirschka T. A new proposed severity score for seborrheic dermatitis of the face: SEborrheic Dermatitis Area and Severity Index (SEDASI). [Online].: Elsevier; 2017. Available from: https://www.jaad.org/article/S0190-9622(17)30575-3/fulltext.

8.

Zhang F LYRWLS. Establishment of clinical evaluation criteria for scalp seborrheic dermatitis. [Online].: Wiley; 2023. Available from: https://doi.org/10.1111/jocd.15804.

9.

HAHNEMANN S. Oraganon of medicine By SAMUEL HAHNEMANN. 5th ed. SARKAR BK, editor.: Birla publication pvt.Ltd.; 2016-2017.

10.

Kippax JR. A Handbook of skin diseases and their homoeopathic treatment. 2nd ed. Chicago: Duncan brothers; 1884.

11.

Samuel L. Homoeopathic therapeutics. 4th ed. Philadelphia : Boerick & Tafel; 1907.

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