Pharmacognostical and Clinico-comparative Study to Evaluate the Efficacy Of Bala moola (Sida cordifolia Linn) and Shalmali (Bombax ceiba Linn) Kantaka lepa in Mukhadooshika .
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- By the Application of Shalmali Kantaka to the subjects of mukhadushika may be beneficial to reduce the number of pidaka and helps to enhance the colour and complexion in coparision with bala moola lepa.
研究概览
简要总结
METHODS OF COLLECTION OF DATA:
Research Design
1. Study Design: Pharmacognostical and open label, two-arm, randomized clinical trial.
2. Sample Size: 30 subjects of Mukhadooshika.
3. Selection Criteria: Diagnosed subjects of Mukhadooshika will be selected on the basis of simple randomized sampling procedure by preparing special case proforma.
4. **Duration:**21 days.
5. Time : Slight dry (10 -15 minutes)
6. Thickness : Ardhangula (0.97cm)
7. Grouping**:** 30 subjects will be allocated into two groups, consisting of 15 subjects in each group.
Trial Group 1- will be treated by using Paste of Bala moola churna with milk applied externally 1 time daily for 21 days
Control Group 11- will be treated by using Paste of Shalmali kantaka churna with milk applied externally 1 time daily for 21days
FOLLOW UP:
Treatment duration will be 21 days for each group
Follow up after treatment- 10thday for each group
Total duration of study will be 31 days.
INCLUSION CRITERIA:
- Subjects in the age group between 12-30 yrs.
2.Subjects fulfilling the diagnostic criteria of Mukhadooshika will be randomly selected irrespective of gender, religion, and occupation.
EXCLUSION CRITERIA:
1.Subjects aged less than 12 years and more than 30 years.
Subjects having other skin diseases like psoriasis, skin tuberculosis and other systemic diseases
History of allergy to topical applications.
ASSESSMENT CRITERIA:
The subjective and objective parameters of base line data during and after treatment will be compared for the assessment of the result**.**
PARAMETERS:
SUBJECTIVE PARAMETERS:
Signs and Symptoms of Mukhadooshika as well as Acne Vulgaris explained in ayurvedic and modern texts respectively such as: Pidaka, vedana, medogranthi, comedones, papules, pustules, nodules will be taken into consideration
1)Vedana (pain):
OBJECTIVE PARAMETERS:
Number of Pidaka (eruption):
Global Acne grading system.
Score of Pidaka on the basis of affected area.
**LOCAL SCORE (F XS):**After calculating local score for each location of the face, total of score will be done. Then on basis of Acne severity index, severity is calculated.
STATISTICAL ANALYSIS: Statistical evaluation of above parameters will be carried
out by using Student’s ‘t’ test. i.e. Paired (within the group ) , Unpaired (between the group).
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
- 12.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects in the age group between 12-30 yrs.
- •2.Subjects fulfilling the diagnostic criteria of Mukhadooshika will be randomly selected irrespective of gender, religion, and occupation.
排除标准
- •Subjects in the age group between 12-30 yrs.
- •2.Subjects fulfilling the diagnostic criteria of Mukhadooshika will be randomly selected irrespective of gender, religion, and occupation.
结局指标
主要结局
By the Application of Shalmali Kantaka to the subjects of mukhadushika may be beneficial to reduce the number of pidaka and helps to enhance the colour and complexion in coparision with bala moola lepa.
时间窗: 21 Days and follow-up will be on 31st day
次要结局
- Number of Pidaka (eruption)(Global Acne grading system.)
研究者
Dr Pallavi
N K Jabshetty Ayurvedic Medical College and PG center