A clinical trial to evaluate the efficacy of oral administration of Clitoria ternatea Linn. powder and Saraswata Ghrita Nasya in the management of Autism Spectrum Disorder in paediatric population.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Improvement in cardinal features of Autism Spectrum Disorder assessed with ISAA
研究概览
简要总结
INTRODUCTION:
Autism spectrum disorders, a cluster of syndromes that share marked abnormalities in the development of social and communicative skills. Data from developed countries suggest that 1 in 150 children are affected by such disorders. As per DSM-5, people with ASD have difficulty with communication and interaction with other people, restricted interests and repetitive behaviours, Symptoms that affect the person’s ability to function in school, work, and other areas of life. Recent estimated prevalence of ASD in India ranges from 0.15% to 1.01% in various studies, depending on the screening method used and area surveyed. Based on typical clinical features, ASD can be correlated with Unmada in Ayurveda.
OBJECTIVES OF THE RESEARCH PROJECT:
PRIMARY:
1. To assess the clinical efficacy of oral administration of Clitoria ternatea Linn. powder and Saraswata Ghrita Nasya on cardinal features of Autism Spectrum Disorder in paediatric population.
SECONDARY:
1. To assess the improvement in sleep disturbances.
2. To improve Quality of Life (QOL) of the children.
3. To reduce the stress level of Parent/Caregiver.
METHODOLOGY:
TYPE OF STUDY DESIGN: A Randomized, Open Label Controlled, Double Arm, Comparative Clinical Study.
SETTING: OPD, Department of Kaumarabhritya, AIIA, Sarita Vihar
SAMPLE SIZE: 47 (in each group)
AGE RANGE: 2-12 years (Either of gender)
GROUPING AND DRUG REGIMEN:
GROUP: 2
GROUP A:
Poorva Karma: (1st-7th Day)
➢ Deepana-Pachana with Chitrakadi vati 250 mg X 1-2 TABX TID X 3days
➢ Mridu virechana with Abhyadi Modaka 1-2 TAB on 4th day
➢ Nasya with Anu Taila X 4-8 drops X OD X 3 days
Main Course (8th-49th day):
➢ Clitoria ternatea Linn. powder with Madhu- Orally
➢ Saraswata Ghrita- Nasya (3 intermittent cycle of 7 days with 7 days of interval)
➢ Behavioural Interventions
| S.No |
Age
(Yrs)
Dose
(Clitoria ternatea)
|1.
2-5
2-3 gm in two divided doses
|2.
6-9
~= 4.5 gm in two divided doses
|3.
10-12
~= 6 gm in two divided doses
| Age (yrs) |
Saraswata Ghrita (in each nostril)
|2-5
4 drops
|6-9
6 drops
|10-12
8 drops
GROUP B:
➢ Placebo- (Wheat powder capsules 250mg)X 1-2 tablets twice a day
➢ Behavioural Interventions
DURATION OF STUDY: 49 days
FOLLOW UP: 49 days
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
- 2.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children between 2-12 years of age, either of gender, fulfilling the screening criteria of Autism Spectrum Disorder and Parents/Guardian are willing to give informed written consent to participate, will be included in the study.
排除标准
- •Children with chronic systemic illnesses or taking anti-epileptic or anti-psychotic drugs or Parents/Guardian not willing to give informed written consent to participate, will be excluded from the study.
结局指标
主要结局
Improvement in cardinal features of Autism Spectrum Disorder assessed with ISAA
时间窗: 0, 7th, 14th, 21st, 28th, 35th, 42nd, 49th day
(Indian Scale for Assessment of Autism) test manual.
时间窗: 0, 7th, 14th, 21st, 28th, 35th, 42nd, 49th day
次要结局
- 1.To assess the improvement in sleep disturbances.(2.To improve Quality of Life (QOL) of the children.)