Pharmaceutical standardization of Tiktashatpalaka Ghrita and its comparative clinical efficacy administered internally with its external application (ointment) and only external application in the management of Vicharchika (Eczema)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Comparative evaluation of efficacy of Tiktashatpalaka Ghrita internally and its
研究概览
简要总结
INTRODUCTION
The drug proposed for evaluation of comparative efficacy in the present research work is Tiktashatpalaka Ghrita, and its ointment is effective in the management of Vicharchika (eczema). But no previous scientific research work has been carried out to prove the comparative efficacy of Tiktashatpalaka Ghrita and its ointment in the management of eczema. Therefore, the present work is an attempt to test pharmaceutical variants in the management of Vicharchika (eczema*)*.
Modern medical science has medicines for symptomatic relief for diseases like eczema, along with side effects for steroids, which are the specific treatment for eczema. So the study is planned to find out the alternative effective management of Vicharchika from ancient texts, which is cheap and effective.
Patients fulfilling the inclusion criteria will be selected from OPD & IPD ITRA, Jamnagar. Patients will be selected from the age group of 18-60 years of either sex, irrespective of religion or caste.
Details of trial procedure and drugs:Both the trial drug (Tiktashatpalaka Ghrita and its ointment) will be prepared in the Dept. of RSBK by classical methods. A minimum of 60 patients (30 in each group) fulfilling the inclusion criteria (details mentioned in the synopsis) will be selected from the OPD & IPD of ITRA, Jamnagar, and randomly divided into 2 groups. Diagnosis will be done on the basis of signs & symptoms and investigations (if needed). A patient information sheet will be prepared, and written consent will be taken. CTRI registration will be done before starting the clinical trial.
Posology, duration of administration, and follow-up:In Group A, each patient will receive Tiktashatpalaka Ghrita internally (6 g twice a day, early morning empty stomach and 2 hrs before dinner) and its ointment externally in sufficient quantity for even application (morning and evening) and In Group B, ointment of Tiktashatpalaka Ghrita externally in sufficient quantity for even application (morning and evening) will be given, and there will be a follow-up for 4 weeks.
Status of ongoing medicines and treatment:Ongoing management of Vicharchika (Shamana, Rasayana Chikitsa) and modern treatment of eczema-like moisturizers, topical antibiotics, antihistamines, topical calcineurin inhibitors, and topical corticosteroids will be held 7 days before the commencement of treatment; systemic steroids shall be tapered off gradually, and no additional medicaments will be given. If a patient has an exacerbation of their condition in both groups during the treatment period or follow-up period, they shall be withdrawn from the study and shall be managed accordingly or referred to a concerned physician.
Dietary restrictions/advice: Patients will be advised to avoid aggravating factors mentioned in ancient literature.
Results and Statistical Analysis: Results will be assessed on the basis of improvement in subjective parameters like cardinal symptoms and objective criteria before and after treatment and at the end of the follow-up period. TLC, DLC, ESR, and Absolute Eosinophil Count (AEC) will be conducted before and after treatment and at the end of the follow-up period. The information gathered on the basis of observations made about various parameters will be subjected to statistical analysis with parameters like mean, SD, and CV. For quantitative data, paired and unpaired t-tests, and for qualitative data, the Wilcoxon signed rank test will be applied. Regression analysis will be applied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient having classical signs and symptoms of Vicharchika like Kandu, Vaivarnyata, Rukshata, and Srava.
- •Uncomplicated cases with classical signs and symptoms of Vicharchika will be selected irrespective of gender, religion, and profession.
排除标准
- •Age less than 18 years and more than 60 years.
- •Pregnant and lactating women.
- •Uncontrolled Diabetes Mellitus & Hypertension.
- •Any other serious systemic illness.
- •Patients who are not willing for inclusion in the study.
结局指标
主要结局
1. Comparative evaluation of efficacy of Tiktashatpalaka Ghrita internally and its
时间窗: 1.5 years
ointment externally as that of only external application of its ointment in the
时间窗: 1.5 years
management of Vicharchika (eczema).
时间窗: 1.5 years
次要结局
- 1. Study shall generate data of evidence to evaluate add on effect of(internal administration of Tiktashatpalaka Ghrita in the patients with external)