| CTRI Number |
CTRI/2017/09/009834 [Registered on: 19/09/2017] Trial Registered Prospectively |
| Last Modified On: |
31/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [oral Spray] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to compare the efficay and safety of Instavit oral spray for the Occassional Sleeplessness |
|
Scientific Title of Study
|
“A Prospective, interventional, single center, randomised, parallel, double blind, and Placebo controlled clinical study to evaluate the efficacy & safety of Instavit® Sweet Dreams oral spray in the treatment of occasional sleeplessness. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No: ICBio/CR/INS/0207/70 Version 01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bindumathi PL |
| Designation |
HOD and Professor of General Medicine |
| Affiliation |
Sapthagiri Institute of Medical Science & Research Centre |
| Address |
#15 Chikkasandra Hesargatta Main road
Bangalore
KARNATAKA
560090
India |
| Phone |
9738877298 |
| Fax |
|
| Email |
drinduraghu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harisha s |
| Designation |
Director operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16 & 18 ICBio Tower,
Yelahanka Main Road,
Chikkabettahalli, Vidyaranyapura
Bangalore
KARNATAKA
560 097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harisha s |
| Designation |
Director operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16 & 18 ICBio Tower,
Yelahanka Main Road,
Chikkabettahalli, Vidyaranyapura
KARNATAKA
560 097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| Instavit Ltd
2-4 Devonshire Street
London
W1W 5DT
united kingdom
|
|
|
Primary Sponsor
|
| Name |
Instavit Ltd |
| Address |
2-4 Devonshire Street London W1W 5DT |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 |
| Dr Bindumathi PL |
Sapthagiri Institute of Medical Science & Research Centre |
General medicine Department #15 Chikkasandra Hesargatta Main road
Bangalore
KARNATAKA |
9738877298
drinduraghu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri Institute of Medical Science & Research Centre, Instiutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F99||Mental disorder, not otherwise specified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Instavit® Sweet Dreams 7ml/0.24 Fl OZ
Sleep Aid Supplement with Melatonin & Chamomile
|
Spray 1-2 times into your mouth 30 minutes before sleep for 28 days |
| Comparator Agent |
Placebo without active Ingredient |
Spray 1-2 times into your mouth 30 minutes before sleep for 28 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects who works in shifts and who travels regularly facing problems of jetlag and occasional sleeplessness.
2. Subjects Meet Criteria for Insomnia Disorder as per Epworth sleepiness scale.
3. Subjects who scores less than 21 of Insomnia Severity Index.
4. Mentally, physically and legally eligible to give informed consent.
5. Subjects willing and able to provide informed consent voluntarily
6. Subject is willing and able to comply with all trial requirements
|
|
| ExclusionCriteria |
| Details |
1. Significant medical or psychiatric illness
2. Diagnosed or occult sleep disorders (evident on screening polysomnography) other than Primary Insomnia
3. Subjects with high severity of Insomnia scoring more than 21 of Insomnia Severity Index.
4. Hearing or memory impairments
5. Subjects having history of drug or alcohol abuse
6. Previous receipt of Study Drug
7. History of HIV, HAV, HBs Ag
8. Volunteers who have participated in any drug research study within past 3 months.
9. Presence or history of hypersensitivity to any of the active or inactive ingredients
10. Pregnant or lactating women |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Improvement in overall condition by assessing the changes in sleep quality using sleep logs and sleep dairy from baseline to EOT. |
Baseline to End of Treatment (28 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Incidence and Rate of adverse events
2. Changes in insomnia severity from baseline to EOT by using insomnia severity index
3. Assessment of sleep quality by using Pittsburgh insomnia rating scale
|
Baseline to End of Treatment (28 days) |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/10/2017 |
| Date of Study Completion (India) |
17/01/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="7" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A prospective interventional single center Randomised Double Blind Placebo controlled clinical study to evaluate the Efficacy and Safety of Instavit Sweet dreams oral spray in the treatment of Occassional sleeplessness
Total of 50 subjects
Duration of the study will not exceed 37 days
The primary and secondary outcome is to compare the efficacy and safety of Instavit sweet dreams oral spray .
|