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

Not Applicable

Completed

• Conditions: Health Condition 1: null- Subjects with Sleep Irregularities

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-09-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• 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 Subjectsâ?? participation in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes from basline value in <br/ ><br>PSQI score <br/ ><br>Hamiltonâ??s Anxiety rating scale score. <br/ ><br>DASS 21 Score <br/ ><br>Sleep EEG <br/ ><br> <br/ ><br>Timepoint: <br/ ><br>Day 0, Day 15, Day 30

Secondary Outcome Measures

Name	Time	Method
Changes in Serum cortisol LevelTimepoint: Day0, Day 30