| 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
|
|
|
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
|
|
|
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. |