Clinical Trial to Evaluate the Efficacy of Ksheeridruvalkadi Lepa in the Management of Padadari
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- • To determine the efficacy of Ksheeridruvalkadi Lepa in reducing the pain associated with Padadari.
研究概览
简要总结
Clinical Trial to Evaluate the Efficacy of Ksheeridruvalkadi Lepa in The Management of Padadari.
Padadari is a common skin disease which is described in Kshudra Roga Adhikarana. It is caused due to vitiation of Vata dosha. It affects the people irrespective of age and gender. It is caused due to Atichankramana and aggravates by Vataprakopaka Ahara and Vihara. It is characterised by cracks/fissures in the feet with pain and dryness of feet. It mainly affects the heel of foot. It can be correlated to cracked foot or heel fissures. Ksheeridruvalkadi Lepa is a yoga from Arogyakalpadrumam, 16th chapter and is indicated in conditions like Vipadika, Padavadaranam (Crack foot), and Padadaha (burning sensation of foot). Ksheeridruvalkadi Lepa has Vatapittahara, Vranaropaka, Twakdoshahara properties which helps in Samprapti Vighatana of Padadari. The study is an attempt to clinically analyse the efficacy of Ksheeridruvalkadi Lepa in Padadari.
The present study is an interventional study with pre- and post- test without control group. Consecutive subjects with signs and symptoms of Padadari belonging to age group 18 to 60 years, irrespective of gender, registered in OP Department of Kayachikitsa, Pankajakasthuri Ayurveda Medical College Hospital, satisfying the inclusion criteria will be recruited until attaining the sample size. After collecting baseline data, detailed history and examinations will be done using case record form. The selected 30 subjects will be given external application of Ksheeridruvalkadi Lepa twice daily for 45 minutes after cleaning the area with lukewarm water for a period of 14 days. Subjective parameters and objective parameters will be assessed on 0th day, 8th day, 15th day and 30th day. The results obtained will be analysed statistically and conclusion will be drawn.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects having cracks/fissures in the feet with or without pain and/or itching will be selected.
- •Subjects between the age of 18 and 60 years irrespective of gender and socio-economic status.
- •Subjects who are willing to sign the consent form and agreeing to follow the protocol of the study.
排除标准
- •Subjects with Skin diseases as secondary manifestations to systemic illness.
- •Subjects suffering from psoriasis, eczema, allergic conditions.
- •Subjects having Cellulitis or ulcers in the foot, discharge from cracks and suppurative infections
- •Pregnant women and lactating mothers.
结局指标
主要结局
• To determine the efficacy of Ksheeridruvalkadi Lepa in reducing the pain associated with Padadari.
时间窗: Subjective parameters: | • Pain | • Itching | • Dryness | Objective parameters: | • Number of fissures | • Average length of fissures | • Average depth of fissures | Assessment will be done on 0th day, 8th day, 15th day and 30th day | Investigations: | Laboratory tests will be performed on 0th day which includes: | • Fasting Blood Sugar | • Blood Routine Examination with Erythrocyte Sedimentation Rate
• To determine the efficacy of Ksheeridruvalkadi Lepa in reducing the number of cracks.
时间窗: Subjective parameters: | • Pain | • Itching | • Dryness | Objective parameters: | • Number of fissures | • Average length of fissures | • Average depth of fissures | Assessment will be done on 0th day, 8th day, 15th day and 30th day | Investigations: | Laboratory tests will be performed on 0th day which includes: | • Fasting Blood Sugar | • Blood Routine Examination with Erythrocyte Sedimentation Rate
次要结局
- To assess the safety of Ksheeridruvalkadi Lepa in Subjects(• Absolute Eosinophil Count)
研究者
Dr Arun Pratap MD Ay
Pankajakasthuri Ayurveda Medical College & Post Graduate Centre, Kattakada, Thiruvananthapuram.