A study to evaluate the effect of BlaQmax (Black cumin seed oil) on sleep quality, stress and anxiety

Completed

• Conditions: Subjects with Sleep Irregularities

• Registration Number: CTRI/2018/03/012391
• Lead Sponsor: Akay Flavours and Aromatics Private Limited

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

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Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-16
• Study Completion: 2017-09-30
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• 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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes from basline value in	Day 0, Day 15, Day 30
PSQI score	Day 0, Day 15, Day 30
Hamilton’s Anxiety rating scale score.	Day 0, Day 15, Day 30
DASS 21 Score	Day 0, Day 15, Day 30
Sleep EEG	Day 0, Day 15, Day 30

Secondary Outcome Measures

Name	Time	Method
Changes in Serum cortisol Level	Day0, Day 30

Trial Locations

Locations (1)

Aman Hospital and Research Centre; 🇮🇳 Vadodara, GUJARAT, India

Aman Hospital and Research Centre

🇮🇳Vadodara, GUJARAT, India

Dr Aman Khanna

Principal investigator

amankhanna11974@gmail.com