Randomized controlled clinical study to evaluate efficacy of brihatyadi taila nasya madhukadi taila nasya in management of khalitya with special reference to baldness Androgenic alopecia
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- 1.Visible improvement in sign and symptoms of Khalitya. 2.Assessment of the scalp with the help of Dermatoscope.
研究概览
简要总结
Hair is one of Hair is one of the defining characterises mammals, human have around more than 2 million hair follicles which have both positive as well as negative effect on skin health. It is one of the vital 2 parts of our body which is derived from the ectoderm of the skin, it is work as a protective appendage for the body. Hair loss is silent but devasting problem which may occur to a healthy person also .khalitya or baldness according to great Aacharya Sushruta is a state of falling hair due to vitiated and increased state of Pitta assorted with Vayu, after that the Kapha mixed with Rakta also joins in this event.AcharyaCharak and Ashtang Hridayakar" have included Khalitya in Shiroroga on the basis of Rogasthana and etiopathogenesis of disease which is similar to that of Shiroroga Sushruta Samhita, Ashtanga Sangrah, Madhav Nidana and Yog Ratnakar has included Khalitya under Kshudrarog on basis of less severity and mildness of disease According to Acharya charak and. Sushrut and vagbbhat Nasya is indicated in shiroroga,, According to Ashtang Hridya Bruhatyadi taila is usefull in Khalitya
Proper Authentication and standardization of raw Material and finished product will be done
For Active controll Bruhtyadi Tail Nasya is used. The Study is divided into two arms
Intervention arm - Marsha Nasya with Brihtyadi Tail
comparator Arm - Marsha Nasya with Madhukadi Tail
The Study is single Blind (Participant Blinded) Randomization will be done by using Computer Software 42 Sample Size is taken for each arm making it 84
The volunteers will ask for Marsh Nasya with 8/8 drops of taila for 7 days
seven Days gap will be observed this will be repeated for 3 cycles Assessment of Khalitya will be done by reduction in signs and symptoms and images taken by Dermatoscope
follow will be on 8th,15th,28th and 42nd Days in both groups.
Statistical analysis and appropriate conclusion will be drawn
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient fit For Nasya.
- •2.Both male and female of age group between 15 to 40 years.
排除标准
- •1.Patients whose age is less than 15 and above 40 years.
- •2.Patient with symptoms of asadhya khalitya.
- •3.Patient suffering from any severe systemic disease.
- •4.Any prolonged debilitation associated Hair fall.
- •5.Necessary steps are taken to exclude other conditions as per facilities available in the institute.
结局指标
主要结局
1.Visible improvement in sign and symptoms of Khalitya. 2.Assessment of the scalp with the help of Dermatoscope.
时间窗: 5 to 6 weeks
次要结局
未报告次要终点
研究者
Kavita Hilal Shirsath
R.A. Podar Medical (ayu) College Worli ,Mumbai.