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CTRI Number  CTRI/2020/10/028474 [Registered on: 20/10/2020] Trial Registered Prospectively
Last Modified On: 16/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Placebo]  
Study Design  Randomized, Crossover Trial 
Public Title of Study   Quantifying placebo effect on psychomotor and cognitive functions in adult healthy human volunteers: an open-label, assessor-blind, cross-over randomized control study 
Scientific Title of Study   Quantifying placebo effect on psychomotor and cognitive functions in adult healthy human volunteers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Archana 
Designation  Senior Resident 
Affiliation  AIIMS 
Address  Room No. 4022, 4th Floor, Teaching Block, Department of Pharmacology

South
DELHI
110029
India 
Phone  09650482430  
Fax    
Email  archanapmv@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr KH Reeta 
Designation  Professor 
Affiliation  AIIMS 
Address  Room No. 4008, 4th Floor, Teaching Block, Department of Pharmacology

South
DELHI
110029
India 
Phone  9711204141  
Fax    
Email  reetakh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr KH Reeta 
Designation  Professor 
Affiliation  AIIMS 
Address  Room No. 4008, 4th Floor, Teaching Block, Department of Pharmacology


DELHI
110029
India 
Phone  9711204141  
Fax    
Email  reetakh@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Ansari Nagar, New Delhi, Pin-110029 
 
Primary Sponsor  
Name  Archana 
Address  All India Institute of Medical Sciences, New Delhi 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Archana  All India Institute of Medical Sciences  Room No. 5005, Convergence block, Department of Pharmacology, Ansari Nagar, New Delhi, Pin - 110029
South
DELHI 
9650482430

archanapmv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  No treatment  No intervention 
Intervention  Placebo  Participants will be told placebo is an stimulant. Placebo softgel capsule (300mg) containing only capsular material will be given single dose. 
Intervention  Placebo  Participants will be told this may be stimulant or inert substance. Placebo softgel capsule (300 mg)containing only capsular material will be given single dose. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Healthy Participants of either gender with age 20-45 years
Education qualification of at least graduation
Participants free from any disease requiring treatment
Participants willing to give informed consent
 
 
ExclusionCriteria 
Details  Participants taken any medicine in the last 7 days
History of clinical anxiety, depressive state or any other psychiatric illness
History of visual or auditory impairment
Pregnant and lactating women
Inability to understand the given instructions
Substance abuse disorders including excessive intake of alcohol, tobacco (more than 10 cigarettes / day), coffee, tea or drinks containing caffeine (equivalent to more than 4 cups per day)

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of single dose placebo, on psychomotor function in healthy human volunteers when compared with no-treatment group  Day 4,5,6 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the effect of single dose placebo, on memory of healthy human volunteers when compared with no-treatment group.  Day 4,5,6 
2. To evaluate the effect of single dose placebo, on executive function of healthy human volunteers when compared with no-treatment group  Day 4,5,6 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
Final Enrollment numbers achieved (Total)= "54"
Final Enrollment numbers achieved (India)="54" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/11/2020 
Date of Study Completion (India) 31/08/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Manuscript Accepted; not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Placebo has been found to have beneficial effects in many psychoneurological conditions like pain, depression, Parkinson’s disease and many others. It can be conceptualized as healing power of mind. The effect has been seen in clinical trial as well as clinical practice settings. Alternative therapies with elaborate rituals and distinct environmental cues can have pronounced and clinically significant placebo effect. It is imperative to study the placebo phenomenon from basic science, clinical trial and ethical perspectives to better understand how placebo operate in clinical settings. Neurobiologically, they have been found to be due to release of endogenous opioids and dopamine. Dopamine has also been studied to be central to mechanism of attention and working memory in human beings. It has been imperative that intact consciousness, preserved mental faculties and moderate pathological dysfunction are needed for demonstration of pathological effect. However, a negative interaction has been studied between drug and placebo and in some cases effect of active drug decreases with increasing placebo effect. This indicates that effects of placebo and active intervention may not be simply additive, and we need to quantify placebo effect which can be best done when compared to no-treatment. It would be unethical to recruit no-treatment group in diseased conditions. It has been evidenced earlier that deceptive administration of placebo simulated clinical situations in that subjects were led to believe that they were receiving an active drug. In contrast, subjects in double-blind conditions were aware that they might receive a placebo. Double-blind and deceptive administration of the placebo produced different results in studies of mood, blood pressure and heart rate. However, placebo compared to no-treatment has not been studied.  Moreover, response to reward mechanisms of placebo effect may be different in healthy and diseased states. Thus, this study has been planned to study and measure the true effects of placebo in healthy human volunteers.

 
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