A COMPARATIVE CLINICAL STUDY ON TUVARAK TAILA CREAM AND 2 PERCENT TOPICAL KETOCONAZOLE IN THE MANAGEMENT OF SIDHMA KUSHTHA (PITYRIASIS VERSICOLOR) IN CHILDREN- AN OPEN LABELLED RANDOMIZED CONTROLLED CLINICAL TRIAL
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1 Antifungal effect of Tuvarak taila cream by performing KOH test.
研究概览
简要总结
**RESEARCH TITLE- A comparative clinical study on Tuvarak Taila cream and 2% topical ketoconazole in the management of Sidhma kushtha (pityriasis versicolor) in children-**An open labelled randomised controlled trial
RESEARCH QUESTION: - What is the effect of local application of Tuvarak taila cream in comparison to 2% topical ketoconazole in the management of Sidhma kushtha (pityriasis versicolor) in adolescent children between 10 to 16 years of age.
HYPOTHESIS
Local application of Tuvarak taila cream will be more effective as compared to the localapplication of 2% ketoconazole cream in the management of Sidhma kushtha (pityriasis versicolor) in adolescent children between 10 to 16 years of age.
NULL HYPOTHESIS
Local application of Tuvarak taila cream is equally effective as compared to the local application of 2% ketoconazole cream in the management of Sidhma kushtha (pityriasis versicolor) in adolescent children between 10 to 16 years of age.
ALTERNATIVE HYPOTHESIS
Local application of Tuvarak taila cream is more effective as compared to the local application of 2% ketoconazole cream in the management of Sidhma kushtha (pityriasis versicolor) in adolescent children between 10 to 16 years of age
NEED OF THE STUDY-
This disease although does not have any serious effects but have a widespread affect on the mental health of the child. The patients of the skin diseases are prone to experience physical, emotional and socio- economic embarrassment in the society due to disfigured appearance
It significantly diminishes the confidence of adolescents, particularly given their heightened concern for appearance during this crucial developmental stage. Top of FormIt can affect the confidence and self esteem of the child,in turn hampering the academic performance and overall development of child.Child can become isolated and withdraw themselves from social interactions and may distance themselves from peers, family members, or others in their environment. Also, persistent recurrence of tinea versicolor poses a significant challenge, necessitating the formation of other formulations to effectively address this challenge. There are very limited studies on ayurvedic intervention in Sidhma kushtha in addition to that the palatability of ayurvedic drugs in children is an immensly challenging .Thus an attempt has been made on use of Tuvarak taila cream in management of Sidhma kushtha*.*
OBJECTIVES
PRIMARY OBJECTIVE
· a) To compare the efficacy of Tuvarak taila cream applied for 3 weeks and 2% topical ketoconazole cream applied for 2 weeks in the management of Sidhma Kushtha (pityriasis versicolor) based on KOH examination and to assess the improvement in clinical features of Sidhma Kushtha as per classical texts of Ayurveda.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 10.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients between 10 to 16 years of age irrespective of gender.
- •2.Patients with clinical signs of the disease Sidhma Kushtha (Pityriasis Versicolor)- Rajoghrishtma vimunchyati (Furferaceous scales) Tamra Varna (Reddish black,brown coloured macules) AlabupushpaVarna(Hypopigmentedmacules/hyperpigmented macules) Kandu (Itching) Urdhav kaye especially Uras (chest, trunk or neck) Tanu (thin plaques)
- •Patients found positive for KOH test
- •Willing to give assent/consent for the trial.
排除标准
- •1.Children with congenital anomalies, chronic ailments such as tuberculosis, malignancy, cardiac, and renal disorders, autoimmune disorder or any other systemic illness 2.Patient have received systemic antifungal therapy within 1 month or topical antifungal therapy within 1 week of the commensal of study.
- •3.Patients with vitiligo, leprosy, pityriasis rosea, psoriasis, pityriasis alba, tinea capitis, tinea cruris any other skin disease 4.Parents of the patient not willing to participate in the trial.
结局指标
主要结局
1 Antifungal effect of Tuvarak taila cream by performing KOH test.
时间窗: 1 Antifungal effect of Tuvarak taila cream by performing KOH test. | 2 Efficacy of Tuvarak taila cream in management of clinical features of Sidhma kushtha (pityriasis versicolor). i.e. Timeframe On 14th day/21st day (AT)and 42nd /49th day (FU). (Expected 90% improvement) and improvement in clinical features of Sidhma kushtha as per classical texts of Ayurveda
2 Efficacy of Tuvarak taila cream in management of clinical features of Sidhma kushtha (pityriasis versicolor). Timeframe On 14th day/21st day (AT)and 42nd /49th day (FU). (Expected 90% improvement) and improvement in clinical features of Sidhma kushtha as per classical texts of Ayurveda
时间窗: 1 Antifungal effect of Tuvarak taila cream by performing KOH test. | 2 Efficacy of Tuvarak taila cream in management of clinical features of Sidhma kushtha (pityriasis versicolor). i.e. Timeframe On 14th day/21st day (AT)and 42nd /49th day (FU). (Expected 90% improvement) and improvement in clinical features of Sidhma kushtha as per classical texts of Ayurveda
次要结局
- 1.Improvement in quality of life of the child as per Children’s Dermatological Life Quality Index (CDLQI) (Expected 90% improvement)(AT (3weeks for group 1) & (2weeks for group 2) Follow Up After 4 weeks for both groups i.e.(7weeks for group 1) & (6weeks for group 2))
研究者
Dr Akshita Thakur
ALL INDIA INSTITUTE OF AYURVEDA