Clinical evaluation of Seenthil Sarkarai (Internal) and Mathan Thailam (External)for the management of Padarthamarai(Dermatophytosis) in children among out-patients attending of Ayothidass Pandithar Hospital,National Institute of Siddha
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction of signs and symptoms of Dermatophytosis by NRS 0 point (no itching) and CDLQI 0 score (no effects on participant’s life) after treatment is expected in study participants.
研究概览
简要总结
BACKROUND:
Dermatophytosis(ICD-11-1F28)isthemostimportant groupofsuperficialfungalinfections caused bydermatophytes, which is a group of fungi that are capable of growing by invadingthe keratin of skin, hair, and nail for obtaining nutrients. There are several reports on intracontinental variability of the global incidence because of the change in climatic condition across the world.[1]According to World Health Organization (WHO), the prevalence rate of superficial mycotic infection worldwide has been found to be 20-25%. [2] It is more prevalent in tropical and subtropical countries like India where the heat and humidityis high for most part of the year. [3]Environmental factors include high temperature and relative humidity, which provide conditions favourable to fungal dispersion and development. Sociodemographic factors, such as poor socioeconomic status, promiscuity, prolonged contact withanimals,andpoorhygieneconditions,arealsoconducivetotheincidenceandpropagationof mycotic infections. [4]
DermatophytesincludeseveralgeneralikeTrichophyton,MicrosporumandEpidermophyton.SomecommonorganismsincludeTrichophytonsudanese,Trichophytontonsurans,Trichophyton verrucous,Trichophyton rubrum, and Microsporum canis. [5] Padarthamarai is one of the common skin disease(kuttam).In Siddha concept,kuttam is a broad term used to denote skin diseases. Yugi muni classified skin disease into 18 types. Padarthamarai can be equated to the most important cutaneous fungal infection due to dermatophytes. Tinea is a common fungal infection which often spreads from one person to another easily through skin contact. Children are more prone than adults since creating awareness among them may be difficult and they get easy skincontact in common places like schools. Also fungal infections are being resistant to medicines in recent days due to frequent use of antibiotics. I have chosen “PADARTHAMARAI” (ISMT4.12.55) as my dissertation topic. Siddha texts describes that padarthamarai is an annular skin lesion in which patches are red in the centre and darkredonedgesresemblingthepetalsoflotusso.ItisalsocalledasPundareegamkuttamThese symptoms are similar to the symptoms of dermatophytoses of modern literature ,Antifungal propertypertainingdrugsareusedtotreatpadarthamarai.Consideringandreviewingalltheabove Seenthil sarkari as internal medicine and Mathan thailam as external application is chosen for PADARTHAMARAI in children for my dissertation.
OBJECTIVE:
To evaluatethe therapeuticeffectiveness of theSeenthilsarkaraiasinternalandMathan thailam as external in the management of Padarthamarai (Dermatophytosis) in children.
METHODOLOGY:
Studydesignandconduct ofthestudy Studytype:Anopen-label,Single-arm,Single-centrephaseIIclinicaltrial.
Studyplace:AyothidossPanditharHospital,NationalInstituteofSiddha,TambaramSanatorium, Chennai-47
Studyperiod: 18Months
PopulationAndSample**:** 6-12agegroupfulfillingalltheinclusioncriteriaandpassingtheexclusioncriteriamentionedbelow
Number of Patients : 30 participants
INCLUSION CRITERIA:
1. Age: 6-12 years
2. Sex: Both male andfemale children.
3. Participants with clinicalfeatures of Padarthamarai (Dermatophytosis)
4. NRS below 6 points(moderate) and CDLQI below 10 score(moderate) will be included
EXCLUSION CRITERIA:
1. Known cases of Skin diseaseslike contact dermatitis, vitiligo, psoriasis, atopicdermatitis.
2. Other diseases or medications that might directlyinterfere in the study.
3. Diabetes mellitus-Type 1 inparticipants.
EXPECTED OUTCOME:
Reduction of signs and symptomsof Dermatophytosis by NRS 0 point (no itching) and CDLQI 0 score (no effectson participant’s life) after treatment is expected in studyparticipants.
RESULTS AND DISCUSSION:The Result will be statistically analysed and reported.
KEYWORDS: Seenthil Sarkarai, Mathan Thailam,Padarthamarai,Dermatophytosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •Participants with clinical features of Padarthamarai (Dermatophytosis) NRS below 6 points(moderate) and CDLQI below 10 score(moderate)will be included.
排除标准
- •Known cases of Skin diseases like contact dermatitis,vitiligo,psoriasis,atopic dermatitis.
- •Other diseases or medications that might directly interfere in the study Diabetes mellitus -Type 1 in participants.
结局指标
主要结局
Reduction of signs and symptoms of Dermatophytosis by NRS 0 point (no itching) and CDLQI 0 score (no effects on participant’s life) after treatment is expected in study participants.
时间窗: Reduction of signs and symptoms of Dermatophytosis will be assessed after the period of 48 days
次要结局
未报告次要终点
