An Exploratory Study to Evaluate The Effectiveness of Homoeopathic Medicines in Improving Quality of Life of Children Affected with Chronic Dermatoses- A Case Series.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improving quality of life of children affected with chronic dermatoses using CDQLI.
研究概览
简要总结
Research Gap: In Paediatric Dermatology, most studies have focused on individual chronic dermatological conditions such as eczema, psoriasis, or vitiligo. While studies show promising results, most of the available research is based on observational studies, case reports, and small-scale clinical trials. As with any form of medical treatment, it is important to tailor homoeopathic prescriptions to individual patients, considering their overall health, constitutional state, and emotional well-being.
By conducting an exploratory study on chronic dermatoses in the paediatric population, this research aims to provide a holistic view of the prevalence, clinical manifestations, and long-term outcomes. It will also examine factors such as genetic predisposition, environmental influences, and socio-economic determinants, which can vary across age groups.
While these studies have advanced our understanding of specific diseases, there remains a critical gap in comprehensive research that explores the broad spectrum of chronic dermatoses in children and adolescents (0-16) This research could ultimately pave the way for personalized treatment protocols that complement conventional dermatological care, focusing on a more integrative and patient-centered approach for paediatric dermatological conditions.
Research Question: Are Homoeopathic medicines effective in improving quality of life of children affected with chronic dermatoses?
Hypothesis:
Alternate Hypothesis: Homoeopathic medicines are effective in improving quality of life of children affected with chronic dermatoses.
Null Hypothesis: Homoeopathic medicines are not effective in improving quality of life of children affected with chronic dermatoses.
Introduction: Dermatoses is a broad term used to describe any skin condition or lesion. These dermatological issues can profoundly impact a child’s physical appearance and emotional well-being.
Chronic Dermatoses in children present a significant challenge to both diagnosis and management due to their diverse nature and impact on the developing skin barrier and immune system.
Homoeopathy, as a holistic system of medicine, rather than merely focusing on symptomatic relief, homoeopathy aims to restore the body’s balance, stimulate the self-healing process, and This system of medicine holds particular promise for paediatric patients due to its gentle nature, minimal side effects, and individualized approach.
Chronic dermatoses, such as eczema, psoriasis, and acne, can significantly affect children’s quality of life. These conditions cause physical discomfort like itching and pain, disrupting sleep and daily activities. They can also lead to social and emotional challenges, such as self-esteem issues, bullying, and anxiety. School performance may suffer due to missed days or difficulty concentrating. The need for ongoing treatment can be burdensome, and family dynamics may be strained. Early management and emotional support are crucial in improving the overall well-being of affected children.
A successful treatment strategy should be comprehensive, integrating not only homoeopathic remedies but also lifestyle modifications, dietary adjustments, and educational support for parents. Educating caregivers about skin care practices, stress management, and emotional well-being plays a crucial role in optimizing outcomes. When applied in conjunction with medical supervision, this holistic approach offers the best chance for improving the child’s skin condition and supporting their overall health.
This study focuses on observing and witnessing the changes by administration of homoeopathic treatment in paediatric age group of 4-16 years.
Epidemiology:
Paediatric dermatoses are a major health concern in India, causing significant morbidity, with prevalence ranging from 8.7% to 69%, especially among rural and tribal children. The occurrence of skin conditions, such as pyoderma, scabies, fungal infections, eczema, and acne vulgaris, is influenced by factors like socioeconomic status, geography, and environmental conditions. These disorders are more common in areas with poor hygiene and limited healthcare access, highlighting the need for targeted interventions and better healthcare outreach.
While numerous studies and clinical trials have been published across various age groups regarding chronic dermatoses, there has been a noticeable lack of research in the paediatric population since 2023 in homoeopathy.
Many of the existing studies focus either on specific diseases or the efficacy of particular treatments. This study aims to fill this gap by exploring the effect of homeopathic treatments on chronic dermatoses in children, with an emphasis on improving their quality of life.
Review of Literature: Recent studies on dermatological conditions and homeopathic treatments highlight their effectiveness in managing chronic skin issues:
1. Eczema (Atopic Dermatitis): Graphites, Sulphur, and Arsenicum album reduce flare-ups and improve children’s quality of life (Dhar & Ghosh, 2005).
2. Psoriasis: Arsenicum album and Sulphur offer long-term relief and fewer relapses (Gupta et al., 2009; Nagendra et al., 2015).
3. Singh, Swati. “Systematic review of homoeopathic treatment of dermatitis.” Sustainability, Agri, Food and Environmental Research(2023) Etc.
Although These studies provide valuable knowledge for researching and studying various chronic dermatoses and the role of homeopathic treatments in their management but these Recent studies are focuses on particular dermatological conditions and specific homeopathic remedies.
Previous studies have explored paediatric dermatoses, such as the pattern, and prevalence in various regions of India (Thakare S., Singh A and N.). However, research from a homoeopathic perspective remains unexplored. This innovative study aims to assess not only the clinical patterns of paediatric dermatoses but also their impact on the quality of life in children, filling a significant gap in the existing literature.
A] Anatomy
Skin:
1. Definition:
i. The skin serves as the body’s protective shield, enveloping the entire human form and acting as the first line of defence against environmental stressors.
ii. The skin or the integument is the external organ that protects against mechanical trauma, UV light and infection. In addition, the skin is concerned with thermoregulation, conservation and excretion of fluid, sensory perception and, of course, has aesthetic role for appearance of the individual.
Skin Colour: The skin’s hue is shaped by the interplay of several pigments, each contributing to the skin’s tone at varying levels across different regions. These pigments include: Melanin, Melanoid, Carotene, Haemoglobin, Oxyhemoglobin.
Skin Structure: The skin is made up of distinct layers, each playing a crucial role in its protective and functional capabilities:
1. Epidermis: The outermost layer, tasked with providing a barrier, managing water balance, and protecting against harmful UV rays.
2. Dermis: Located beneath the epidermis, this layer houses blood vessels, nerve endings, hair follicles, and sebaceous glands, supporting the skin’s structure and functionality.
3. Hypodermis: The deepest layer, consisting of subcutaneous fat, connective tissue, and blood vessels, providing insulation and cushioning for the body.
Skin Cell Types:
1. Keratinocytes: The dominant cell type in the epidermis, responsible for producing keratin, a vital protein that fortifies the skin’s structure and function.
2. Melanocytes: These cells synthesize melanin, providing skin pigmentation and shielding the skin from UV damage.
3. Langerhans Cells: Immune cells that identify and process antigens, playing a critical role in skin defence.
4. Merkel Cells: Specialized cells that are integral to the sensation of touch, contributing to tactile perception.
Skin Appendages:
1. Hair Follicles: Produce hair that serves to insulate the body, protect the skin, and contribute to sensory detection.
2. Sebaceous Glands: Secrete sebum, an oily substance that lubricates and protects the skin from environmental damage.
3. Sweat Glands: Release sweat, aiding in temperature regulation and the removal of waste products from the body.
Skin Blood Flow & Lymphatics:
1. Blood Vessels: Deliver oxygen and essential nutrients to skin cells while also removing metabolic waste.
2. Lymphatic Vessels: Assist in draining excess fluids, proteins, and waste products from the skin, contributing to fluid balance and immune function.
Skin pH and Hydration:
1. Skin pH: Maintains a slightly acidic environment (around pH 5.5), crucial for skin barrier function and providing defence against microbes.
2. Skin Hydration: Ensures adequate moisture levels, preserving skin elasticity, flexibility, and its protective barrier function.
B] Physiology:
-Function of skin is protection of organs.
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Protective Function: Prevents water loss, protects against external factors (e.g., temperature, humidity, UV radiation), and maintains internal homeostasis.
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Secretory Function: Skin secrets sweat through sweat glands and sebum.
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Sensory Function: Contains nerve endings that detect touch, pressure, temperature, pain, and vibration.
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Storage Function: Skin stores fat, water, chloride and sugar.
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Excretory Function: Eliminates waste products through sweating.
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Regulation Of Body Temperature: Regulates body temperature through sweating, vasodilation, and vasoconstriction.
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Regulation of Water and Electrolyte of body
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Synthetic Function: vit D3 synthesized in skin.
**Definition:**Dermatoses is a common term used for any skin disorder. Dermatoses may be of various types such as genetic, inflammatory, infectious, granulomatous, connective tissue, bullous and scaling type.
ICD-10-CM code:
For chronic dermatoses, the relevant ICD-10-CM code range is given below:
L00-08: Infections of the skin & subcutaneous tissue
L10-14: Bullous Disorders
L20-L30: Dermatitis and eczema.
L28: Lichen simplex chronicus & prurigo.
L29: Pruritus.
L40-40.9: Psoriasis
L 49-54: Urticaria and Erythema.
L60-75: Disorders of skin appendages.
L98.9: Other Paediatric dermatological disorders.
L70.0: Acne vulgaris
B35.0-35.9: Dermatophytosis (tinea).
Classification of skin diseases in Paediatrics:
A. Neonatal (Newborn) Conditions:
Naevi & Genetic Skin Disorders: Birthmarks and inherited skin conditions, including various types of nevi (moles) and genetically driven dermatoses.
Mongolian Spot: Bluish-grey birthmarks, typically found on the back or buttocks, common in darker-skinned infants.
Toxic Dermatoses: Severe skin reactions like toxic epidermal necrolysis, Ritter’s syndrome, Leiner’s syndrome, and dermatitis medicamentosa (resulting from drugs taken by the mother during pregnancy or childbirth).
Infections: Newborns are susceptible to infections such as impetigo neonatorum, syphilis, herpes simplex, and, to a lesser degree, zoster (shingles).
Exanthemata: Skin rashes caused by systemic infections like toxoplasmosis.
Seborrheic Conditions: Includes conditions such as cradle cap, congenital acne, seborrheic dermatitis, and pityriasis capitis (dandruff).
B. Hereditary & Genodermatoses (Inherited Skin Disorders):
Ichthyosis: A group of disorders characterized by dry, scaly skin.
Epidermolysis Bullosa: A rare genetic condition causing fragile skin that blisters easily.
Keratoderma: Abnormal thickening of the skin on the palms and soles.
Ectodermal Dysplasias: A group of disorders affecting the development of skin, hair, nails, and teeth.
Albinism: A genetic condition where the body cannot produce normal pigment, leading to pale skin and hair.
Incontinentia Pigmenti: A rare genetic disorder affecting the skin, hair, teeth, and nails, with distinctive patterns of pigmentation.
C. Eczematous Disorders:
Eczema (Atopic Dermatitis) Atopic dermatitis, commonly known as eczema, is a common chronic, relapsing skin disease characterized by pruritus, disrupted epidermal barrier function, and immunoglobulin E–mediated sensitization to food and environmental allergens. There are 3 classical stages of eczema: infantile, childhood, and adulthood.
Infantile Eczema:
Age: Appears in infants before 6 months.
Symptoms: Red, itchy, inflamed skin, often on the face, scalp, or limbs, with oozing and crusting.
Triggers: Allergens (dust mites, pet dander), fabrics, temperature changes, soaps.
Childhood Eczema:
Age: Occurs between 2-5 years of age.
Symptoms: Dry, scaly rashes, mainly on elbows, knees, and hands, with thickened skin.
Triggers: Allergens, food allergies, stress, skin infections.
D. Infections:
Pyoderma & Viral Warts: Skin infections caused by Human papilloma virus family presented with Cauliflower like growth on various parts of our body, generally with no itching and discharge.
Scabies & Candida: Parasitic skin infections and fungal infections causing rashes, itching, and discomfort.
Fungal Infections (Ringworm): Tinea (Ringworm): Tinea is a very common skin disorder caused by Trichophyton, Microsporon and Epidermophyton species group of dermatophytes presented with annular or arcuate or polycyclic lesion which is spread centrifugally where margin of the lesion is active with papulovesicular eruption, pustule and scaling where centre is comparatively clear In case of chronic lesion there maybe hyper pigmentation and lichenification present on the site. According to the appearance on the parts of the body, it is classified as- tinea capitis (on scalp), tinea corporis (on trunk and limbs), tinea cruris (on groin), tinea pedis or athlete’s foot (on foot), tinea mannum (on hands), tinea unguium (on nails) etc.
E. Erythematous-Squamous Disorders:
Psoriasis: Around 10% of individuals with psoriasis develop symptoms before the age of 10, and 25% before the age of 20. It is a chronic inflammatory skin disease with a strong genetic predisposition and autoimmune pathogenic traits. It shows a lower prevalence in Asians.
1.Plaques-type Psoriasis: About 90% of psoriasis cases correspond to chronic plaque-type psoriasis. The classical clinical manifestations are sharply demarcated, erythematous, pruritic plaques covered in silvery scales. The plaques can coalesce and cover large areas of skin. Common locations include the trunk, the extensor surfaces of the limbs, and the scalp.
2.Guttate Psoriasis: Guttate psoriasis is a variant with an acute onset of small erythematous plaques. It usually affects children or adolescents and is often triggered by group-A streptococcal infections of tonsils.
3.Pustular psoriasis: Pustular psoriasis is characterized by multiple, coalescing sterile pustules. Pustular psoriasis can be localized or generalized. Affects the hands and feet.
4.Lichen Planus & Pityriasis Rubra Pilaris: Rare skin conditions characterized by red, itchy, and scaly patches. It can be anywhere on the body but usually it can appear on wrist and ankles.
F. Hair Disorders:
Alopecia: Hair loss, which may be temporary or permanent.
Hirsutism: Excessive hair growth in areas where males typically grow hair.
Dystrophies: Abnormalities in the structure of the hair, affecting growth or texture.
G. Seborrheic Conditions:
Seborrheic Dermatitis: Common in both infants and children, causing flaking and red skin, particularly on the scalp.
**Acne Vulgaris:**Acne vulgaris, commonly known as pimples is a frequent skin condition, especially during puberty when sebaceous glands are most active. It often starts with seborrhoea oleosa and comedones. Acne can affect both genders, with males experiencing more severe cases. Acne usually appears on the face, neck, chest, shoulders, and back, often symmetrically, with enlarged pores due to excess oil production.
H. Nail Disorders:
Congenital Nail Abnormalities: Birth defects affecting the shape, size, or structure of nails.
Tinea (Fungal Nail Infections): Common fungal infections that affect the nails, causing discoloration and thickening.
I. Bullous Eruptions:
Juvenile Dermatitis: Conditions leading to blistering of the skin.
Bullous Impetigo: A severe form of impetigo that causes blisters on the skin.
**Urticaria:**It is common annoying allergic reactions that result in hives, swelling, and itching, often triggered by insect bites or allergens affecting almost 10-15% of the population, no age is exempt but its incidence is highest at puberty and middle age.
K. Pigmentary Disorders:
Vitiligo: Rare before the age of one year, causing depigmented patches on the skin. It is a skin disorder where there is focal failure of pigmentation due absence of functional melanocyte by auto-immunological destruction mainly. Characterised by depigmented milky white macular lesion on various parts of skin along with the depigmentation of the hair of that part.
Pityriasis Alba: Conditions that cause lighter spots on the skin, often seen in infancy.
Seborrhoeides: Skin conditions characterized by scaly, pigmented lesions.
Homoeopathic approach:
Miasmatic analysis is a crucial aspect of homoeopathic treatment for skin diseases, as emphasized by Dr. T. F. Allen, who believed that most skin conditions are a secondary or tertiary result of miasmatic action.
Psoric Skin: Psoric skin is typically dry, rough, and unhealthy-looking, often with a sensation of being unwashed. Itching and burning are common, and eruptions appear with dryness or mild suppuration. These conditions are aggravated in the evening, before midnight, and by heat or undressing. Psoric diseases include eczema, measles, chickenpox, boils, chilblains, and ichthyosis.
Syphilitic Skin: The syphilitic skin appears dull, moist, and sweaty, often showing ulceration and deep tissue damage. Eruptions are typically found around joints and flexures, with a copper or brownish-red color at the base. Syphilitic skin conditions generally lack itching and have minimal soreness. Common diseases include warts, lichen planus, and herpes zoster.
Sycotic Skin: The sycotic skin is oily, greasy, and shiny, often marked by moles, warts, and excessive body hair. There is hyperpigmentation in various body parts. Diseases associated with sycosis include warts, tinea, and abscesses.
Pseudo-Psora/Tubercular Skin: This condition often involves glandular involvement with skin issues. White speckles on nails may indicate pseudo-psora. Common diseases include ringworm, varicose ulcers, herpes, urticaria, and leprosy.
Tri-Miasmatic Skin: Conditions like psoriasis, skin cancers, erysipelas, and lupus are often considered tri-miasmatic, involving a combination of psoric, syphilitic, and sycotic influences.
This miasmatic framework helps guide the individualized homeopathic treatment of skin diseases.
Homoeopathic Remedies:
Homeopathic treatment for paediatric dermatoses focuses on a thorough understanding of the child’s physical and emotional state. By considering the totality of symptoms, homeopathy aims to personalize treatment based on the principle of “similia”—treating the child with a remedy that matches their unique symptom profile. Below are some of the commonly used homeopathic remedies for children suffering from various skin ailments.
Calcarea Carbonica
Indication: For children with chronic skin conditions like eczema, worsened in cold weather.
Key Symptoms: Thickened, dry, itchy skin, rashes on flexor areas, slow development.
Sulphur
Indication: For chronic, itchy skin conditions like eczema with burning and intense itching, worsened at night.
Key Symptoms: Red, inflamed skin, intense itching, aggravated by heat.
Graphites
Indication: For eczema with thickened, oozing, cracked skin, especially in skin folds.
Key Symptoms: Oozing, sticky discharge, fissures in skin folds.
Natrum Muriaticum
Indication: For eczema triggered by emotional stress, with dry, cracked skin.
Key Symptoms: Dry, chapped skin, aggravated by sun or stress, introverted behaviour.
Rhus Toxicodendron
Indication: For acute or chronic itching, redness, worsened by cold or damp weather.
Key Symptoms: Itchy, red skin with blistered eruptions, improved by heat.
Arsenicum Album
Indication: For burning, itching skin conditions like eczema and psoriasis.
Key Symptoms: Burning, restless, cold-aggravated, dry and scaly skin.
Antimonium Crudum
Indication: For chronic acne or thickened skin with scabs, warts, bad nail & hair quality and pustules.
Key Symptoms: Thick, rough skin with scabs and pustules, irritability.
Hepar Sulphuris
Indication: For infected, pustular eczema or sensitive, inflamed skin.
Key Symptoms: Pus-filled eruptions, sensitive skin, irritability.
Mezereum
Indication: For chronic scaling, crusting, thick, dry skin like in psoriasis and eczema.
Key Symptoms: Thick, crusty skin, large patches of peeling.
Objective:
1. Primary Objective: To explore the effectiveness of homoeopathic medicines in improving quality of life of children affected with chronic dermatoses using CDQLI.
2.Secondary Objective: To study the most common Homoeopathic medicine in treating Chronic dermatoses in paediatrics.
Methodology:
1. Study Design: Case series
2. Study Setting: The cases will be collected from college OPD, Medical Camps and peripheral OPDs.
3. Duration of Study: 18 months.
4. Method of selection of study subjects
- Inclusion criteria:
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Patients whose parents giving consent for the study.
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Age group of 4-16.
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Patient with affection of dermatoses.
- Exclusion criteria:
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Patient with severe pathological changes which threatened life.
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Patients whose parents not giving consent for the study.
5. Method of selection of comparison or control group: NA
6. Matching criteria: NA
7. Operational definition:
Individuals of 4-16 age group having chronic dermatoses of more than 3 months, are managed with homoeopathy. The effectiveness of homoeopathic medicines will be measured by the reduction in skin lesion severity and improvement in overall skin health, using standardized scoring systems such as assessing the quality of life in affected children through tools like Dermatological quality of life index (CDLQI) questionnaire.
8. Specific instruments and related measurement:
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Repertory (Radar Opus Synthesis 10).
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CDLQI Questionnaire
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Case record format
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Homoeopathic materia medica.
Research Methodology specified and explained for data collection:
1.Sample size: 30
2.Sampling technique: Simple Random Sampling.
3.Method for data collection relevant to objectives-
i. Target population who gives consent as well as qualifying the inclusion and exclusion criteria will be selected and interrogated as per case record format.
ii. Detail case taking will be taken of each case and Repertorization will be done.
iii. Homoeopathic medicine will be prescribed for each case based on symptom similarity.
iv. Follow up will be taken as per need.
4.Data management and analysis procedure: The data will be analysed with excel sheet and appropriate data analysis tool will be taken.
Timeline:
| TASK |
Duration
1
2
3
4
5
6
7
8
9
10
11
12
|Case Collection
6 months
X
X
X
X
X
X
|Follow up with patient
12 months
X
X
X
X
X
X
X
X
X
X
X
X
|Data Analysis
2 months
|Report writing and conclusion
3 months
| TASK |
Duration
13
14
15
16
17
18
|Case Collection
|Follow up with patient
|Data Analysis
3 months
X
X
X
|Report writing and conclusion
3 months
X
X
X
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 4.00 Year(s) 至 16.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients whose parents giving consent for the study.
- •Patient with affection of dermatoses.
排除标准
- •Patient with severe pathological changes which threatened life.
- •Patients whose parents not giving consent for the study.
结局指标
主要结局
Improving quality of life of children affected with chronic dermatoses using CDQLI.
时间窗: 3 months and 6 months
次要结局
- to find out the most common Homoeopathic medicine in treating Chronic dermatoses in paediatrics.(after 6 months)
研究者
Dr Monika Ananda Pawar
Motiwala National Homoeopathic Medical College and Hospital, Nashik
