Comparative clinical evaluation of Dadruvidravana Malahara with or without Laghu Manjisthadi Kwath Churna in the management of Dadru Kustha (cutaneous dermatophytosis)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Assessment will be done on both subjective and objective criteria of Dadru Kustha before & after the intervention
研究概览
简要总结
Title of the study: COMPARATIVE CLINICAL EVALUATION OF DADRUVIDRAAVANA MALAHARA WITH OR WITHOUT LAGHU MANJISTHAADI KWATHA CHURNA IN THE MANAGEMENT OF DADRU KUSTHA (CUTANEOUS DERMATOPHYTOSIS).
It is a randomised comparative clinical study which will be conducted with 100 diagnosed cases of Dadru kustha (cutaneous Dermatophytosis) for 30 days. Routine investigations like Hb%, DC, TLC, RBS, HbA1C (if required), LFT, and RFT need to be done to exclude the other systemic disorders. Microscopic examination of 10% potassium hydroxide (KOH) wet-mount preparations of skin scrapings from the active border of the lesions. Patients age ranging from 21 to 60 years will be included in the study. The trial drug Laghu manjisthadi kwath will be given orally at a dose of 48 ml twice daily for a period of 30 days with the external application of Dadruvidravana malahara. The detailed clinical record will be kept in a specified CRF before the initiation of treatment. Prior informed written consent will be taken from the patient to be included in the trial. the follow up and improvements will be recorded in the CRF on 15th day, the 30th day of treatment and 2weeks after completion of treatment. Any adverse reaction during the treatment will be reported to the Pharmacovigilance cell of CCRAS and rescue medication will be applicable as per institution norms. Ethical approval-The study has received IEC approval to be carried out.
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
- 21.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1- Patients with age group between 21 – 60 years of age.
- •2-Patients irrespective of gender, socio-economic and marital status.
- •Patients willing to participate in the study for a minimum period of 4 weeks.
排除标准
- •Patients below 21 and above 60 years of age.
- •Patients associated with other type of Kustha.
- •Patients presenting with Dadru Kustha suffering with any other systemic disorders.
- •Lesions with secondary infections.
- •Patients with severe renal or hepatic dysfunction.
- •Patients with Uncontrolled Diabetes Mellitus.
- •Pregnant women and lactating mother.
结局指标
主要结局
Assessment will be done on both subjective and objective criteria of Dadru Kustha before & after the intervention
时间窗: Assessment will be done on baseline, after 15 days and after 30days on completion of the treatment
次要结局
- To assess the effectiveness of Dadru vidravana malahara on Dadru kustha with or without Laghu Manjisthadi Kwath in the management of Dadru kustha(Assessment of the effectiveness of Dadru vidravana malahara & Laghu Manjisthadi Kwath in Dadru will be assessed on baseline, after 15days & after 30days of treatment)
研究者
Dr Itishree Bandana Rth
Central Ayurveda Research Institute