| CTRI Number |
CTRI/2021/12/038901 [Registered on: 24/12/2021] Trial Registered Prospectively |
| Last Modified On: |
23/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Ayurvedic therapy for the children with autistic features. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
Autism spectrum disorder, Saraswata Ghrita, Nasya, Ayurveda |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Masooda |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room No. 406, Department of Kaumarabhritya, 4th floor Academic block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar
South West
DELHI
110076
India |
| Phone |
9968522196 |
| Fax |
|
| Email |
masu.noor543@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajagopala S |
| Designation |
Head of Department and Associate Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no. 404, Department of Kaumarabhritya, 4th floor Academic block, All India Institute of
Ayurveda, Gautampuri, Sarita Vihar.
South West
DELHI
110076
India |
| Phone |
7600902564 |
| Fax |
|
| Email |
srajagopala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Masooda |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room No. 406, Department of Kaumarabhritya, 4th floor Academic block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar
South West
DELHI
110076
India |
| Phone |
9968522196 |
| Fax |
|
| Email |
masu.noor543@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda, Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda,Gautam Puri, Sarita Vihar, Delhi-110076 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Masooda |
All India Institute of Ayurveda |
OPD 205, Kaumarabhritya Department, Hospital Block,
South West
DELHI |
9968522196
masu.noor543@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F840||Autistic disorder. Ayurveda Condition: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Charak Samhita, Sidhhi sthana, Chapter 9, Sutra 116-117, Procedure details: The procedure of administering medicines via the nasal route (trans-nasal medication), which is among the important routes of drug administration in the Ayurvedic medical system.)
(1) Medicine Name: Saraswata Ghrita, Reference: Ashtanga Hridya, Uttartantra, Chapter 1, Sutra 45, Route: Nasal, Dosage Form: Ghrita, Dose: 0.8(ml), Frequency: od, Duration: 3 Weeks | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sweta-Sankhpushpi (Clitoria ternatea)), Reference: Charak Samhita, Chikitsa Sthana, Chapter 1 / part 3, Sutra 30-31, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: -Madhu (Honey)), Additional Information: The Medicine will be procured from GMP certified pharmacy. | | 3 | Comparator Arm (Non Ayurveda) | | - | Behavioral Therapy | It is a scientifically structured strategy to teaching play, communication, social living skills, etc. as well as reducing harmful behaviors. It has been shown in numerous studies to improve results for children with autism. |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in cardinal features of Autism Spectrum Disorder assessed with ISAA
(Indian Scale for Assessment of Autism) test manual. |
0, 7th, 14th, 21st, 28th, 35th, 42nd, 49th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
|
0 day and 49th day |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/12/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="4"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |