A clinical trial to Evaluate Efficacy and Safety of Traditional Indian Medicine (TIM) of Siddha formulations in Children with Autism.
- Conditions
- Health Condition 1: F01-F99- Mental, Behavioral and Neurodevelopmental disordersHealth Condition 2: F989- Unspecified behavioral and emotional disorders with onset usually occurring in childhood and adolescence
- Registration Number
- CTRI/2020/09/028149
- Lead Sponsor
- Manushyaa Blossom Private limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
1. Patients with DSM-V diagnosis of Autistic Disorder
2. Male or female patients Ã?Æ? 5 years and Ã?â?? 17 years of age
3. Patients with weight Ã?Æ? 15 kg
4. Patients on anticonvulsants used for treatment of seizure disorder with the dosage has been stable for 4 weeks and patient seizure free for at least 6 months
5. Clinical Global Impression Severity score of at least 4
6. Patients living with parents or caretaker
7. Patients whose parents are willing to give free written consent
8. Patients with language, hearing and vision compatible with the study measurements as judged by the investigator
9. No allergies to any of the ingredients of the study drug
10. Patients having no allergy to sulpha drugs 11. Patient are willing to follow the protocols requirements
1. Patients below the age Ã?â?? 5 years and Ã?Æ? 17 years of age
2. Patients who is not willing to participate in the study
3. Patients with IQ below 18 months
4. Patients with an evidence of hypersensitivity to any of study product components
5. Patients with history of neuroleptic malignant syndrome
6. Patents with DSM-V diagnosis of Pervasive Developmental Disorder other than Autistic Disorder
7. Patients with a significant concomitant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, or unstable seizure disorder
8. Patients with weight less than 15 kg
9. Patients requiring initiation of a major change in psychosocial intervention (including investigational) within 4 weeks prior to screening
10. Patients with a risk of suicidal behavior 11. Patients with medical history of alcohol or substance abuse/dependence
12. Patient has participated in another clinical study involving another investigational agent within 4 weeks of the start of this trial, or is planning participation in another clinical trial during the current study duration
13. Patient with known hypersensitivity to individual ingredients of the study drug
14. Patients with presence of any symptom indicating serious or malignant disease
15. Patient having a Medical or social condition that would, in the opinion of the investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method