Single arm clinical study to assess the efficacy of Amruta Kwathpan and Tulasi Swaras Lep in the management of Sheetpitta with special reference to Chronic Urticaria
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To study the effect of Amruta kwathapan and tulasi swaras lep in the management of sheetpitta
研究概览
简要总结
Aims- to assess the efficacy of Amruta kwathpan and Tulasi swaras lep in the management of Sheetpitta
1.Primary objective -To Study the effect of Amruta Kwathpan and Tulasi Swaras Lepa in the management of Sheetpitta
2.Secondary objective
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To study Sheetpitta in Ayurvedic perspective.
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To study Amruta Kwath and Tulasi Swaras lep in detail in Sheetpitta
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To study the efficacy of Amruta Kwath and Tulasi Swaras Lepa in Sheetpitta
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To Study chronic Urticarial in detail
Type of Study Design: Single Arm Clinical Study.
Study Settings
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All the clinical studies will be carried at our Ayurveda hospital OPD Age group between 6 to 12 year
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Pathological investigation will be done at Ayurveda hospital, department of Pathology CBC abcolute eosinophil count and LFT as per Required.
Study Population
All the diagnosed cases of Shittapitta attending in our Ayurved hospital OPD and IPD.
Study Duration
Duration of entire study :- 18 months
Duration of treatment :- 15 days
Follow up:- 5th ,10th ,15th day
Diagnostic criteria:-
Patient will be diagnosed on the basis of clinical sign
ssessment criteria-
Subjective parameter are based on symptomatic relief i.e. mandala, kandu, toda,daha
The data obtained will be analyzed statistically.
Observation and Results: The observed Clinical Efficacy of treatment will be observed and recorded.
Discussion: Results will have discussed on the basis of collected data and statistical analysis.
Conclusion: It will be drawn strictly on the basis of statistical analysis.
Summary: The research study will be summarized in brief.
Ethical Consideration: The study will be conducted in accordance with ethical guidelines and inform consent from participant.
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
- 6.00 Year(s) 至 12.00 Year(s)（—）
入选标准
- •1.Patient diagnosed as sheetpitta as per sign and symptoms.
- •2.Gender as-irrespective of gender and socioeconomic status 3.age- above 6 to 12 years school age.
排除标准
- •Age above 12 yrs patients.
- •Patients who are not taking proper follow up.
- •3.Patients who have history of any other illness 4.Patients suffering from carcinoma, DM, HIV, HBSAg positive 5.Allergic contact dermatitis, psoriasis, fungal infection,Angioedema 6.Drug induced Urticaria.
- •7.Patients having history of or k/c/o- any chronic diseases .e.g. Heart diseases, Paraplegia, diabetes mellitus, hypertensive, Chronic kidney disease, liver disease, HIV 8.Hypersensitivity reactions to any drug.
- •9.Patients not willing for the treatment and not giving written consent.
结局指标
主要结局
To study the effect of Amruta kwathapan and tulasi swaras lep in the management of sheetpitta
时间窗: 7 days
次要结局
- 1.To study the sheetpitta in ayurvedic perspective(2. study amruta kwathpan and tulasi swaras lep in sheetpitta)
研究者
DrTejaswini Vitthalrao Patil
LRP Ayurvedic medical college and hospital, PG Institute and Research center