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CTRI Number  CTRI/2023/12/060745 [Registered on: 26/12/2023] Trial Registered Prospectively
Last Modified On: 22/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study of the effect of Alpha lipoic acid in addition to the usual treatment drug in schizophrenia patients 
Scientific Title of Study   A Randomized Double Blind Placebo Controlled trial Evaluating the Efficacy of Alpha Lipoic Acid as Add-On Therapy on Cognitive Impairment in Schizophrenia Patients of a Tertiary Care Hospital  
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 Ramya R 
Designation  Post graduate 
Affiliation  SRM medical college 
Address  Depertment of Pharmacology SRM MCH and RC Kattankulathur
Depertment of Pharmacology SRM MCH and RC Kattankulathur
Chennai
TAMIL NADU
603203
India 
Phone  8072866218  
Fax    
Email  rp9521@srmist.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr V Sathyanarayanan 
Designation  Professor  
Affiliation  SRM medical college 
Address  Depertment of Pharmacology SRM MCH and RC Kattankulathur
Depertment of Pharmacology SRM MCH and RC Kattankulathur

TAMIL NADU
603203
India 
Phone  9384633405  
Fax    
Email  sathyanv@srmist.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr V Sathyanarayanan 
Designation  Professor  
Affiliation  SRM medical college 
Address  Depertment of Pharmacology SRM MCH and RC Kattankulathur
Depertment of Pharmacology SRM MCH and RC Kattankulathur
Chennai
TAMIL NADU
603203
India 
Phone  9384633405  
Fax    
Email  sathyanv@srmist.edu.in  
 
Source of Monetary or Material Support  
SRM Medical College Hospital and Research Centre SRM Nagar Kattankulathur Chengalpattu district Tamilnadu 603203 
 
Primary Sponsor  
Name  Dr Ramya R 
Address  Department of Pharmacology SRM MCH and RC Kattankulathur 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramya  SRM MCH and RC  Department of Pharmacology SRM MCH and RC Kattankulathur chennai 603203
Kancheepuram
TAMIL NADU 		 8072866218

rp9521@srmist.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM INSTITUITIONAL ETHICS COMMITTEE BMHR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F209||Schizophrenia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Alpha lipoic acid  Alpha lipoic acid Administration of ALA 300 mg oral once daily for 3 months as an adjunct to antipsychotic medication 
Comparator Agent  Placebo  Placebo once daily, Oral Tablet, as an adjunct to antipsychotic medication for 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Schizophrenia diagnosis made by research psychiatrists using the Structured Clinical Interview, SCID-5, for Diagnostic and Statistical Manual of Mental Disorders of more than 2 years duration and on treatment
2)Cognitive symptoms despite adequate antipsychotic treatment assessed by MOCA scored < 26
3)Age 18-60 years of either gender
4)Willing to participate
 
 
ExclusionCriteria 
Details  1)6-months history of any drug or alcohol abuse or dependence
2)Changes in psychotropic medications within the last 4 weeks and patients on valproate use (potential interaction with ALA)
3)Women who are planning to become pregnant, are pregnant, or are breastfeeding
4)Known chronic infections such as HIV or hepatitis C, and liver or renal failure that could adversely impact on patient outcome
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
1) Effect of alpha lipoic acid on executive functioning-attention, inhibition, working memory, Orientation through Montreal Cognition Assessment scale  Baseline to 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1)Effect of alpha lipoic acid on improving cognition and disability
2) Effect of alpha lipoic acid on quality of life  		 Baseline to 12 weeks 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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/ Phase 4 
Date of First Enrollment (India)   30/12/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be available in the publications

  6. For how long will this data be available start date provided 05-01-2024 and end date provided 05-07-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Study hypothesis is to show that Alpha lipoic acid as an adjuvant along with the routine treatment is more efficacious than placebo in improving cognitive impairment among schizophrenia patients

 
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