Pharmaceutico-clinical study of Siddarthaka Yoga Taila and ointment and their efficacy in the management of Dadru
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in the size of lesion, Number of Pidikas accounted and observed,Reduction in the frequency of Kandu, Reduction in the redness of the lesions, Photomicrographs taken before and after treatment in selective cases.
研究概览
简要总结
Clinical study:
Setting: Patients suffering from Dadru, will be selected from O.P.D. of All India Institute of Ayurveda, Sarita Vihar, New Delhi – 110076. i
i. Inclusion Criteria: • Patient between the age group of 16 to 60 years. • Patients of both genders. • Patients having classical clinical features of Dadru Kustha. • Positive for fungal dermatophytes(by 10% of KOH,microscopic examination) • Duration of the disease: Chronicity for more than 3 months, recurrent in nature and or not responding to conventional therapy.
iii. Exclusion Criteria: • Patients suffering from Diabetes,Hypertension and other metabolic disorder,Autoimmune disorder. • Pregnant and lactating women. • Chronicity more than 5 years. • Lesions with secondary infections. • Patients taking immunosuppressive medicines.
iii. Method of Data Collection: The data of the selected patients (those who comply with the inclusion criteria) will be enrolled. The selected patients shall undergo the series of events before the treatment, which include Informed Consent on the study, their demographic details and a detailed history.
iv. Grouping : 60 patients will be randomly assigned in three groups
Group 1 – Patient will be given orally Siddharthaka Kashaya (20 ml twice a day before meals) along with local application of Siddharthaka Yoga Taila (Quantity Sufficient).
Group 2 - Patient will be given orally Siddharthaka Kashaya (20 ml twice a day before meals) along with local application of Siddharthaka Yoga Ointment (Quantity Sufficient).
Group 3 – Patient will be given orally Siddharthaka Kashaya(20 ml twice a day before meals)along with local application of ointment base.
v. Duration of study: 28 days. Patients would be provided drugs for every 7 days for four weeks. Routine blood investigations (CBC, ESR, BSL, LFT, KFT) will be done , if required.
vi. Assessment Criteria: a. Changes in the size of lesions. b. Number of Pidikas accounted and observed. c. Reduction in the frequency of Kandu. d. Reduction in the redness of the lesions. e. Photomicrographs taken before and after treatment in selective cases.
Follow Up Follow up will be done on 14th day after the completion of treatment.
i. Parameters of Assessments of Study outcomes:
Overall assessment of the results will be made by considering the collective effect on all the parameters and scoring criteria.
ii. Statistical method for analysis:The parameters of base line data will be compared with the follow up status for assessment of the results.
All the results analysis will be done by using SPSS ver.20 software, and obtained results will be interpreted statistically for ‘p’ value. Repeated measures Anova test
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
- 16.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient between the age group of 16 to 60 years.
- •Patients of both genders.
- •Patients having classical clinical features of Dadru Kustha.
- •Positive for fungal dermatophytes(by 10% of KOH,microscopic examination)
- •Duration of the disease: Chronicity for more than 3 months, recurrent in nature and or not responding to conventional therapy.
排除标准
- •Patients suffering from Diabetes,Hypertension and other metabolic disorder,Autoimmune disorder.
- •Pregnant and lactating women.
- •Chronicity more than 5 years.
- •Lesions with secondary infections.
- •Patients taking immunosuppressive medicines.
结局指标
主要结局
Changes in the size of lesion, Number of Pidikas accounted and observed,Reduction in the frequency of Kandu, Reduction in the redness of the lesions, Photomicrographs taken before and after treatment in selective cases.
时间窗: 28 days
次要结局
- No recurrence of signs and symptoms(14 days)