Ayurvedic therapy for the children with autistic features.
- Conditions
- Autistic disorder. Ayurveda Condition: UNMADAH,
- Registration Number
- CTRI/2021/12/038901
- Lead Sponsor
- All India Institute of Ayurveda
- Brief Summary
**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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 94
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in cardinal features of Autism Spectrum Disorder assessed with ISAA 0, 7th, 14th, 21st, 28th, 35th, 42nd, 49th day (Indian Scale for Assessment of Autism) test manual. 0, 7th, 14th, 21st, 28th, 35th, 42nd, 49th day
- Secondary Outcome Measures
Name Time Method 1.To assess the improvement in sleep disturbances. 2.To improve Quality of Life (QOL) of the children.
Trial Locations
- Locations (1)
All India Institute of Ayurveda
🇮🇳West, DELHI, India
All India Institute of Ayurveda🇮🇳West, DELHI, IndiaDr MasoodaPrincipal investigator9968522196masu.noor543@gmail.com