Effectiveness and safety of hemp seed drink in stress or anxiety patients: a randomized double-blinded controlled trial

Phase 2

• Conditions: stressanxious; stress; anxiety

• Registration Number: TCTR20230425003
• Lead Sponsor: SCISEEIT Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-25
• Study Completion: 2023-10-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Male or female with age from 18 to 60 years
2. Participants who diagnosed mild to moderate stress or anxious
3. Participants who willing to participate the study

Exclusion Criteria

1. Pregnant or breastfeeding woman.
2. Participants with elevated liver enzymes more than two times of normal upper limit.
3. Participants with chronic kidney disease or acute kidney injury.
4.Participants with chronic liver disease or acute liver injury.
5. Participants with severe psychosis disease.
6. Participants who experienced allergy to any ingredient of Hemp seed.
7. Participant who misused drugs.
8. Participants with other underlying diseases or medical problems that would interfere with the study.
9. Participants who undergo other treatments for stress or anxiety.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anxiety score measured by Thai HADS Week 4 Anxiety score measured by Thai HADS

Secondary Outcome Measures

Name	Time	Method
Stress score measured by Thai Perceived Stress Scale-10 Week 4 Stress score measured by Thai Perceived Stress Scale-10,Sleep quality measured by Thai Pittsburgh Sleep Quality Index (Thai PSQI) Week 4 Sleep quality measured by Thai Pittsburgh Sleep Quality Index (Thai PSQI),Serum cortisol level Week 4 Serum cortisol level,Safety outcome Week 4 Liver kidney function test