A RANDOMIZED DOUBLE ARM COMPARATIVE CLINICAL STUDY TO ASSESS THE EFFICACY OF SWAYAMBHUVA GUGGULU AND SAPTAAMRITA LAUHA ALONG WITH NIMBA TAILA PRATIMARSHA NASYA IN AKALA PALITYA VIS-A-VIS PREMATURE CANITIES
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- SUBJECTIVE PARAMETERS
研究概览
简要总结
Present study is a double arm clinical study with Pre-test and Post-test assessment. Minimum of 50 subjects diagnosed with Akala Palitya fulfilling the diagnostic and inclusion criteria will be incidentally selected and randomly categorized into two groups as Group A and Group B each consisting of 25 Subjects for the clinical study excluding the dropouts.
Sample Size: 50
Group A:
| Sample Size Minimum of 25 Subjects. | |
| Amapachana Shunti Choorna with Ushnaambu. 5gram Twice a Day, Before Food - Till Nirama Lakshana are seen. | |
| Nasya Nimba Taila, Pratimarsha nasya (2 drops each nostrils) for 30 days. | |
| Shamana Aushadhi Swayambhuva Guggulu with Milk as Anupana. | |
| Matra 500 mg, Twice a day, after food for 60 days. |
GROUP B:
| Sample Size Minimum of 25 Subjects. | |
| Amapachana Shunti Choorna with Ushnaambu. 5gram Twice a Day, Before Food - Till Nirama Lakshana are seen. | |
| Nasya Nimba Taila, Pratimarsha nasya (2 drops each nostrils) for 30 days. | |
| Shamana Aushadhi Saptaamrita Lauha with Milk as Anupana. | |
| Matra 500 mg, Twice a day, after food for 60 days. |
Follow up:
- Follow up during the intervention: a. On 0th Day.
b. On 30th Day.
c. On 60th day
- Follow up on completion of the intervention: On 75th day post treatment.
PATHYAPATHYA: Subjects of both Groups will be advised Pathya Apathya.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
入选标准
- •Subjects having classical Signs and Symptoms of Akala Palitya like Kesha Varna(Colour of hair), Rooksha Sphutita(dry split hair), Snigdha Sthoola(unctuous thick hair), Daha (burning sensation).
- •Subjects within age group of 18-30 years irrespective of Gender and Occupation.
- •Subjects indicated for Nasya.
排除标准
- •Subjects with Premature Canities as a part of other conditions such as Vitiligo, Cutaneous disease involving the scalp and any of the Pre-diagnosed systemic diseases.
- •Subjects with Pernicious Anaemia and any other Autoimmune diseases.
- •Subjects with Hormonal diseases and Hereditary disorders.
- •Pregnant and lactating women.
结局指标
主要结局
SUBJECTIVE PARAMETERS
时间窗: Total duration - 60 Days
Premature change in the color of hair with one of the below symptoms
时间窗: Total duration - 60 Days
Dry splitted hair
时间窗: Total duration - 60 Days
Oilyness of hair
时间窗: Total duration - 60 Days
Burning sensation of scalp
时间窗: Total duration - 60 Days
OBJECTIVE PARAMETERS
时间窗: Total duration - 60 Days
Graying Severity Score11: The entire Scalp Surface is divided in 5 zones (Frontal, Vertex, Right
时间窗: Total duration - 60 Days
and Left Temporal Regions, Occipital). A 1cm2 area showing maximum graying is identified
时间窗: Total duration - 60 Days
and marked to count the number of white hair
时间窗: Total duration - 60 Days
To check the parameters as follows
时间窗: Total duration - 60 Days
次要结局
- To check the parameters as follows(SUBJECTIVE PARAMETERS)
研究者
Dr Tejashwini D Sathale
Ayurveda Mahavidyalaya and Hospital, Hubballi