Effect of Dillenia capsule on quality of sleep, anxiety, stress, and depression.

Phase 1

• Conditions: Healthy condition; Dillenia; Quality of sleep; Anxiety; Stress; Depression

• Registration Number: TCTR20230127006
• Lead Sponsor: Agricultural Research Development Agency (Public Organization)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-27
• Study Completion: 2024-01-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Aged between 30-65 years old who live in Northeastern of Thailand
2. Don't have menopause syndromes.

Exclusion Criteria

1. Volunteers who have been diagnosed with one of the following; heart disease, lung disease or allergies, diabetes, high blood pressure, hyperlipidemia, liver disease, kidney disease, cancer, autoimmune disease, hematological disorder, gout or high uric acid, head injury and mental disorder
2. Volunteers who were exposed to pesticides before the test
3. Hysterectomy and/or Oophorectomy
4. Volunteers who use hormones or any drug that effect on Hypothalamic Pituitary Gonadal axis
5. Volunteers who require supplements or any drug that affect the nervous system and bone before the start of the test
6. Volunteers who require supplements or any drug that affect the nervous system by order of the doctor before the start of the test
7. Drinking alcohol more than 5 times per day
8. Smoking more than 10 pieces per day
9. Volunteers who participate in other projects
10. During breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of sleep, Stress, anxiety, depression 2 months questionnaires; Depression Anxiety Stress Scale 21 Thai, Pittsburgh Sleep Quality Index (PSQI)

Secondary Outcome Measures

Name	Time	Method
Evaluation of Monoamine oxidase (MAO), Monoamine oxidase type A and type B, GABA transaminase (GABA-T) and Cortisol 2 months laboratory,Evaluation of Inflammatory markers; Interleukin-6 (IL-6) and C-reactive protein (CRP) 2 months laboratory,Mood evaluation using MOSAIC 2 months questionnaires,Beck Anxiety Inventory (BAI) 2 months questionnaires,Penn State Worrying Questionnaire (PSWQ) 2 months questionnaires