| CTRI Number |
CTRI/2020/03/023779 [Registered on: 05/03/2020] Trial Registered Prospectively |
| Last Modified On: |
03/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [FLAXSEED SUPPLEMENTATION ] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of cognitive behavior therapy versus flaxseed on sleep |
|
Scientific Title of Study
|
Role of cognitive behavior therapy and flaxseed supplementation for promoting healthy sleep in College students |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shweta Kanchan |
| Designation |
Post MD PHD |
| Affiliation |
King Georges Medical University Lucknow |
| Address |
Department of Physiology
King Georges Medical University Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8808390589 |
| Fax |
|
| Email |
drshwetakanchan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shweta Kanchan |
| Designation |
Post MD PHD |
| Affiliation |
King Georges Medical University Lucknow |
| Address |
Department of Physiology
King Georges Medical University Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
|
| Fax |
|
| Email |
drshwetakanchan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shweta Kanchan |
| Designation |
Post MD PHD |
| Affiliation |
King Georges Medical University Lucknow |
| Address |
Department of Physiology
King Georges Medical University Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
|
| Fax |
|
| Email |
drshwetakanchan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sleep Lab Department of Physiology King Georges MedicalUniversity Chowk Lucknow Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Department of Physiology |
| Address |
King Georges Medical University Chowk Lucknow |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Sunita Tiwari |
King george medical university |
Sleep Lab
Department of Physiology
Lucknow
UTTAR PRADESH |
9838999817
sunita_kgmu@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
College students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
cognitive behaviour therapy |
cognitive behaviour therapy CBT for 4 -5 session of 45 min each the module of CBT according to suggestion by clinical psychologist for sleep improvement in medical students |
| Intervention |
flaxseed supplementation |
Roasted flaxseed to be given orally for 1 month every day 1 hrs before bed time |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Undergraduate college students from Lucknow, who have a poor sleep quality or decreased quantity of sleep orhave symptoms of sleep deprivation |
|
| ExclusionCriteria |
| Details |
1 Subjects should not be having any sleep disorder previously
2 Subjects should not be taking any hypnotics
3 Subjects should not be having any Acute or Chronic comorbidity which interferes with sleep.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of CBT and flaxseed on the objective sleep quality of college students as accessed by polysmnography |
1 month after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of salivary melatonin before and after the CBT and flaxseed internventions |
10 months |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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
|
N/A |
|
Date of First Enrollment (India)
|
06/03/2020 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study has been designed to evaluate weather interventions like cognitive behavior therapy and nutritional interventions by giving flaxseed will improve the sleep quality and quantity in undergraduate college students , as accessed by polysomnographic parameters of sleep as well as other parameters which indicate the circadian sleep /wake rythm of these students
|