Effect of AYUSHMANAS a coded drug in Cognitive deficit

Phase 2

• Conditions: Health Condition 1: F70- Mild intellectual disabilities

• Registration Number: CTRI/2019/07/020324
• Lead Sponsor: CCRAS MINISTRY OF AYUSH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Children of either sex aged in between 8 to 13 years.

2. Children with Intelligence Quotient 63 â?? 80 as per BKT

3. Willing and able to participate for 6 months

(Consent to be obtained from Parent(s) / Guardian(s)/ Assent from children wherever possible).

Exclusion Criteria

1.Children with a history of peptic ulcer disease, any gastric or duodenal surgery, gastrointestinal (GI) bleeding or other GI disorders.

2.Children with severe infection and/or clinically significant hepatic, respiratory, renal, cardiac or hematological disorders.

3.Children with abnormal laboratory values at admission in to the study: serum creatinine 1.2 > mg/dl, SGOT, SGPT >3times upper limit of normal; serum Bilirubin or Alkaline phosphatase >1.5 times upper limit of normal

4.Patientâ??s guardian who cannot be relied upon to comply with the test procedures or are unwilling to give informed consent.

5.The Children had any intramuscular, intra-articular or intravenous carticosteroids within 4 weeks prior to study entry.

6.The Children with a history of recent and clinically significant drug abuse.

7.The Children with pre-existing blood dyscrasias, eg., bone marrow hypoplasia, leukopenia, thrombocytopenia etc.

8.The Children is unlikely to comply with protocol, eg., un cooperative attitude, inability to return for follow-up visits, and unlikelihood of complete study.

9.Children in whom another investigational drug was used with in 3 months prior to entry in this study.

10.Children with poorly controlled epilepsy

(H/o attack in last 3 months).

11.Children to whom BKT canâ??t be administered for any reason

Study & Design

• Study Type: Interventional
• Study Design: Not specified