Effectiveness of Individualized Homoeopathic Medicine in Fifty Millesimal Potency in The Management of Tinea Corporis Among Adults an Experimental Non Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Outcome assessment will be done by applying Dermatophytosis Area Severity
研究概览
简要总结
TINEA CORPORIS is infection of glabrous skin manifested by well demarcated, annular, pruritic scaly lesion that undergo central clearing. Dermatophyte infection of skin is of is often called ringworm. Tinea the Latin word for worm, describes the serpentine nature of skin lesion. Dermatophyte infections are extremely common and usually caused by fungi of the Microspore, Trichophyton and Epidermophyton species. The fungi can originate from soil (geophilic) or animals (zoophilic), or be canned to human skin, anthropophilic.
RELEVANT EPIDEMIOLOGICAL DATA, In India, due to tropical environmental conditions, there is higher prevalence of dermatophytosis. The prevalence of tinea has increased since few years due to unhygienic conditions among people living in crowded damp places, patients having systemic clinical conditions like Diabetes mellitus, human immunodeficiency virus, and among patients who irrationally use antifungal Adults are more commonly affected age group. Males are more commonly affected than females. The factor which predisposes for tinea are sweating, obesity, diabetes mellitus, working in places with high temperature, wearing damp clothes in humid weather, sharing personal clothes with infected person.
EXISTING KNOWLEDGE GAPS AND HOW TO BRIDGE SUCH GAPS, by conducting a well-designed study, uncontrolled, it provides empirical data on whether individualized homeopathy can effectively treat Tinea corporis compared to placebo or conventional antifungals. By assessing long-term outcomes e.g., 3 To 6-month follow-up, study can determine if homeopathy not only treats acute symptoms but also prevents recurrence. Study bridges gaps by, Providing evidence-based validation for individualized homeopathy in dermatomycoses. Offering a comparative perspective against convectional treatment. And exploring long term benefits and recurrence prevention.
In Homoeopathy Hahnemann suggest the judicious, sure, efficacious and radical treatment of the local maladies that occurred from little or no injury from without should be directed against the whole by means of internal remedies. Such treatment must affect the annihilation and cure of general malady which caused it to manifest Dr. Hahnemann, in his 6th edition of Organon of medicine, introduced a new method of dynamization of drugs. He termed it as Renewed Dynamization in aphorism 161. In footnote to aphorism 246, he writes, new altered, but perfected method. In section 270, he mentioned about the preparation of potencies, its repetition depending upon the nature of disease, Chronicity of illness etc. The discovery of 50 Millesimal potency by Dr. Samuel Hahnemann was resultant of the quest for a perfect method of potentization, which took around four decades of eventful, valuable efforts. In his words, this method of dynamization the preparations thus produced, I have found after many laborious experiments and counter-experiments, to be the most powerful and at the same time mildest in action, that is, as the most perfected the material part of the medicine is lessened with each degree of dynamization 50,000 times, yet incredibly increased in power.
Homoeopathic medicines are known to rarely produce side effects and are also cost effective and safe in administration Homeopathy has always offered a safe and significant results in controlling the infections of cutaneous disorders, including atopic dermatitis in the present study we have showed the results of homeopathy in dermatophytes infections in various age group affections. Homoeopathy has always been a safe and cost-effective treatment in cases of dermatophyte infections constitutional individualized medicine for such chronic local affections. Hence study will be undertaken to study effectiveness of individualized homoeopathic medicine in the fifty millesimal potency in the management of tinea corporis among adults. This study bridges the gap by assessing the impact of effectiveness of Individualization homoeopathic medicine in fifty millesimal potency in Management of Tinea corporis among adults thus will provide the clinical evidence for its effectiveness.
Primary objective, To study the Effectiveness of Individualized Homoeopathic Medicine in fifty Millesimal potency in the Management of tinea corporis among adults, up to 6 months or if remission occurs whichever is earlier.
Other objective, To assess the patient pre-treatment and post-treatment scores for tinea corporis among adults prevalidated with Dermatophytosis Area Severity Index up to 6months or if remission occurs whichever is earlier.
STUDY DESIGN , Non Controlled Experimental Study.
APPROPRIATE METHODS OF MEASUREMENT
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Standardized Homoeopathic case taking proforma will be used in each case.
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Improvement of patient will be determined from the help of Dermatophytosis Area Severity Index.
Final severity score is equals to Sum of Body Surface Area affected in hand units multiplied by summation of Pruritus score, Erythema score, Lichenification score , Active Raised Boarders score , with addition of 1 for each Additional Risk factor.
Duration of study is 18 months. Duration of each case is , Each case will be studied for a period of 6 months or if remission occur, whichever is earlier. Duration of Follow up, Each case will be followed up at the interval of 15 days or as and when required. Clinical assessment will be done at baseline, 3rd month and at the end of the treatment or 6th month, whichever is earlier. Score before and after treatment will be compared to assess the improvement. Based on difference between pre and post treatment score of scale, and disease will be assessed as Mild, Moderate, Severe. And patient will be assessed as Improved, Partial improved, Not improved.
This is a non controlled, prospective clinical study intended to explore the role of individualized homoeopathic medicine in fifty millesimal potency treatment in the management of Tinea corporis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 64.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of adult age group Clinically diagnosed patients of Tinea corporis Patients of all genders Patients willing to give their free consent.
排除标准
- •Complication of Tinea corporis like secondary bacterial infection,eczema ,Majocchi granuloma Cases having Tinea corporis infection secondary to Autoimmune disease Cases of immuno-compromised diseases Pregnant and lactating female patients under any line of treatment for Tinea corporis for last3 months Cases whose pretreatment DASI score is above 41.
结局指标
主要结局
Outcome assessment will be done by applying Dermatophytosis Area Severity
时间窗: Duration of study is 18 months. | Duration of each case Each case will be studied for a | period of 6 months or if remission occur, whichever is | earlier. | Duration of Follow up is Each case will be followed up at the interval of 15 days or as and when required. | Clinical assessment will be done at baseline, 3rd month and at the end of the treatment or 6th month, whichever is earlier.
Index score
时间窗: Duration of study is 18 months. | Duration of each case Each case will be studied for a | period of 6 months or if remission occur, whichever is | earlier. | Duration of Follow up is Each case will be followed up at the interval of 15 days or as and when required. | Clinical assessment will be done at baseline, 3rd month and at the end of the treatment or 6th month, whichever is earlier.
A DASI score of 1 to 15 is Considered Mild disease.
时间窗: Duration of study is 18 months. | Duration of each case Each case will be studied for a | period of 6 months or if remission occur, whichever is | earlier. | Duration of Follow up is Each case will be followed up at the interval of 15 days or as and when required. | Clinical assessment will be done at baseline, 3rd month and at the end of the treatment or 6th month, whichever is earlier.
2. A DASI score of 16 to 40 is Considered Moderate disease
时间窗: Duration of study is 18 months. | Duration of each case Each case will be studied for a | period of 6 months or if remission occur, whichever is | earlier. | Duration of Follow up is Each case will be followed up at the interval of 15 days or as and when required. | Clinical assessment will be done at baseline, 3rd month and at the end of the treatment or 6th month, whichever is earlier.
3.A DASI score of more than 41 is Consider Severe disease.
时间窗: Duration of study is 18 months. | Duration of each case Each case will be studied for a | period of 6 months or if remission occur, whichever is | earlier. | Duration of Follow up is Each case will be followed up at the interval of 15 days or as and when required. | Clinical assessment will be done at baseline, 3rd month and at the end of the treatment or 6th month, whichever is earlier.
次要结局
- NOT APPLICABLE(NOT APPLICABLE)
研究者
Dr Utkarsha Uttam Shingare
Dr G D Pol Foundation Y M T Homoeopathic Medical College and PG Institute Hospital
