| CTRI Number |
CTRI/2018/03/012391 [Registered on: 07/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
07/03/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the effect of BlaQmax (Black cumin seed oil) on sleep quality, stress and anxiety |
|
Scientific Title of Study
|
An open label, Single arm clinical study to evaluate the efficacy and safety of BlaQmax (Black cumin seed oil) on sleep quality, stress and anxiety |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aman Khanna |
| Designation |
Principal investigator |
| Affiliation |
Aman Hospital and Research Centre |
| Address |
Room No:1,Department of general medicine,Aman Hospital and Research Centre Pvt Ltd. 15 Shaswat opposite ESI Hospital
Vadodara
GUJARAT
390021
India |
| Phone |
|
| Fax |
|
| Email |
amankhanna11974@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishnakumar I M |
| Designation |
General Manager R and D |
| Affiliation |
Akay Flavours and Aromatics Private Limited |
| Address |
Research and Development Division,1st Floor,Malaidamthuruthu P O
Ernakulam
KERALA
683561
India |
| Phone |
|
| Fax |
|
| Email |
Krishnakumar.IM@akay-group.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Private Limited |
| Address |
No 9 , Myhthri Legacy Ist Floor Chelekere Main Road Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Akay Flavours and Aromatics Private Limited ,Malaidamthuruthu P.O Ernakulam Kerala, India. |
|
|
Primary Sponsor
|
| Name |
Akay Flavours and Aromatics Private Limited |
| Address |
Malaidamthuruthu P.O Ernakulam Kerala, India. |
| Type of Sponsor |
Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients] |
|
|
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 Aman Khanna |
Aman Hospital and Research Centre |
Room No: 1, Department of General medicine, 15 Shaswat opposite ESI Hospital
Vadodara
GUJARAT |
990402122
amankhanna11974@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Aman Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Subjects with Sleep Irregularities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BlaQmax |
Single 200mg capsule every day after the dinner for 30 days. |
| Comparator Agent |
Nill |
Nill |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Age 25-65 Years ( Both Inclusive)
2) Male and Female Subjects
3) Patients suffering from any kind of sleep disorders including insomnia, nocturnal awakening etc.
4) Subject should be suffering from any kind of sleep irregularities for a minimum period of 1 month .
5) Subjects with a PSQI score Greater than 5.
6) Must agree to sign an Informed Consent Document. |
|
| ExclusionCriteria |
| Details |
1) Subject with history of cardiovascular, Type 2 Diabetes mellitus, pulmonary, hepatic and renal problems
2) Subjects who are currently under any kind of long term medication
3) Subjects with a known allergy to herbal products
4) Chronic drinkers
5) Subject with a habit of smoking
6) Subjects with abnormal biochemical or haematological values
7) Subjects with abnormal blood pressure
8) Pregnant or Lactating Women
9) Any condition that in Opinion of the Investigator, does not justify the Subjects’ participation in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes from basline value in
PSQI score
Hamilton’s Anxiety rating scale score.
DASS 21 Score
Sleep EEG
|
Day 0, Day 15, Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Serum cortisol Level |
Day0, Day 30 |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
Final Enrollment numbers achieved (Total)= "18"
Final Enrollment numbers achieved (India)="18" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2017 |
| Date of Study Completion (India) |
30/09/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a Single Centre, Open Label, Single arm Clinical study. The main purpose of the study is to prove the efficacy and benefits of BlaQmax as a health supplement for improving sleep quality .The study will also evaluated the benefits on stress and anxiety. Subjects diagnosed with sleep irregularities are enrolled to participate in the study. Informed consent is obtained before undertaking any study related procedures. Subjects with a PSQI score greater than 5 are enrolled in the study. The subjects visited their designated study site on following 4 different occasions: Screening Day 0 Visist 3 - Day 15 Visist 4- Day 30 §
|