| CTRI Number |
CTRI/2024/08/071895 [Registered on: 05/08/2024] Trial Registered Prospectively |
| Last Modified On: |
03/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of Saraswata Churna with Panchbhautika taila nasya in the management of Autism in children |
|
Scientific Title of Study
|
Evaluation of Saraswata churna with Panchbhautika taila nasya in the management of autism in children- a randomized controlled clinical trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suman Devenda |
| Designation |
MD Scholar |
| Affiliation |
National institute of ayurveda, jaipur |
| Address |
PG Department of Kaumarbhritya
National Institute of Ayurveda
jaipur - 302002
Jaipur RAJASTHAN 302002 India |
| Phone |
9351593040 |
| Fax |
|
| Email |
sumdevanda108@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr Nisha Kumari Ojha |
| Designation |
MD, Ph.D. (AY.) PDCR, B.Sc., Dean(Ph.D) HOD Dept of Kaumarbhritya |
| Affiliation |
National institute of ayurveda, jaipur |
| Address |
PG Department of Kaumarbhritya
National Institute of Ayurveda
jaipur - 302002
Jaipur RAJASTHAN 302002 India |
| Phone |
8890072697 |
| Fax |
|
| Email |
drnishaojha@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prof Dr Nisha Kumari Ojha |
| Designation |
MD, Ph.D. (AY.) PDCR, B.Sc., Dean(Ph.D) HOD Dept of Kaumarbhritya |
| Affiliation |
National institute of ayurveda, jaipur |
| Address |
PG Department of Kaumarbhritya
National Institute of Ayurveda
jaipur - 302002
Jaipur RAJASTHAN 302002 India |
| Phone |
8890072697 |
| Fax |
|
| Email |
drnishaojha@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda
Jaipur - 302002
Rajasthan India |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
National Institute of Ayurveda, jaipur - 302002
Rajasthan India |
| Type of Sponsor |
Government medical college |
|
|
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 Suman Devenda |
Hospital National Institute of Ayurveda, Jaipur |
OPD No. 5
dept of Kaumarbhritya
National Institute of Ayurveda, Jaipur
Rajasthan Jaipur RAJASTHAN |
9351593040
sumdevanda108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA |
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: kashyap samhita kalpasthan , Procedure details: Pratimarsah nasyam 2 drops in each nostril at morning ) (1) Medicine Name: Panchbhautika taila, Reference: kashyap samhita,kalpasthan, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 3 Months | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Saraswata Churna , Reference: Bhaishjya Ratnavali Unmada Rogadhikara Adhyaya 19(26-29), Route: Oral, Dosage Form: Churna/ Powder, Dose: 600(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -madhu and ghrita), Additional Information: - | | 3 | Comparator Arm (Non Ayurveda) | | - | Roasted Wheat Flour | dose-375-600 mg with madhu and ghrita
sevan kala pragbhakta for 3 months |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 03 to 09 years.
2. Diagnosed cases of Autism satisfying DSM 5/ AIIMS Modified INCLEN criteria (INDT- ASD) of either sex
3. Patients with score above 70 in Indian Scale for assessment of Autism (ISAA).
|
|
| ExclusionCriteria |
| Details |
1. ASD medications from any other system
2. Mental retardation, Cerebral palsy
3. Presence of other organic or psychotic neurological disorder
4. Pervasive developmental disorder
5. Hearing and visual impairment
6. Patients with acute and chronic systemic illness such as renal diseases, Hepatic dysfunction, Juvenile diabetes mellitus etc
7. Congenial disorders, Genetic syndromes like Fragile X syndrome, Turner syndrome etc
8. Progressive and non-progressive neuromuscular disorders
9. Endocrinal disorders, Protein Energy Malnutrition (PEM), Inborn error of metabolism
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Change in ISAA score |
baseline, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.-Change in DSM V criteria |
baseline, 3 months |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
01/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="5" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Autism is a complex neuro-developmental disorder that tremendously affects the normal functioning of brain which challenges the child’s development. Autism is characterized by impaired communication (both verbal and nonverbal), impaired interpersonal social interaction and repetitive, restricted and stereotype mannerism of behavior or presence of unusually strong narrow interest. The presentation of these impairments is variable in range and severity and varies with the acquisition of other developmental skills. According to WHO report, it is estimated that worldwide about 1 in 100 children have autismi. In India according to a report by ET Health World, about 18 million people in India are diagnosed with autism. About 1 to 1.5 percent of children aged 2 to 9 years are diagnosed with ASDii. Autism affects more male than female individuals. Etiology of autism is not yet known, but both genetic and environmental factors appear to play role. Environmental factors that may contribute to the etiology of ASD include pre or postnatal exposure to certain environmental chemicals and drugs, stress, maternal infection and dietary factors. Along with this, alteration in gut microbiota (gut dysbiosis) and other GI disorders are found in autistic children. That is derangement in digestive and metabolic system. Autism has close similarities to the features of that Unmada which is described in Ayurveda. The condition due to Dushta Dosha caused by the Mithyahara or Vihara consumption by an Alpa Satva person, which gets lodged in the Sthana of Buddhi, that is Hridaya and later does Margavarana of Manovaha Srotas leading to different lakshanas (manifestations). Looking to the manifestations of Unmada, some of them can be seen in autism spectrum disorders. These include involve impairments of - Manas vibhramam – total or partial loss of sensory perception. Buddhi vibhramam - intellect-partially affected –could be irregular as shown in savant skill. Samjanajana vibhramam- impaired consciousness. Smriti vibhramam –impaired memory. Bhakti vibhramam- impaired desire, loss of innate quality of self-realization. Seela vibhramam- socially inappropriate outbursts and adherence to strict rigid routines. Chesta vibhramam- activities motor stereotype that are improper and compulsive. Achara vibhramam- poor socialization skills, failure to obey orders, loss of healthy habits. |