CTRI/2020/09/028149已完成4 期
A Prospective, Open Label, Double Arm, Parallel Designed, Multicentric Study to Evaluate and Compare the Efficacy and Safety of Traditional Indian Medicine (TIM) of Siddha formulations (Saraswathy Thailam, Amirtha Sanjeevini Chooranam & Kunjari Mezhugu and Saraswathy Thailam, Amirtha Sanjeevini Chooranam & Rasa Senthuram) on Social and Cognitive Behavior of Children with Autism Spectrum Disorder
Manushyaa Blossom Private limited0 个研究点目标入组 32 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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
研究者
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