Effects of Ayurved Siriraj Recipe YaHom No. 20 (AVS020) on sleep quality in healthy volunteer compare to placebo and lorazepam.
Phase 3
Completed
- Conditions
- Sleep qualityYahom20, Sleep quality
- Registration Number
- TCTR20240704003
- Lead Sponsor
- The Agricultural Research Development Agency (Public Organization)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Healthy volunteer
Exclusion Criteria
1. Diseases that result in decreased sleep quality, 2. People who have psychiatric symptoms or diagnoses, 3. People who have history of using drugs that affect sleep quality, 4. People who have history of ADR to lorazepam or ingredients of AVS20 or pollen allergy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method sleep efficiency everyday self-reported using sleep diary,sleep onset latency everyday self-reported using sleep diary,number of awakening everyday self-reported using sleep diary,sleep duration everyday self-reported using sleep diary,sleep quality everyday self-reported using sleep diary, Pittsburgh sleep Quality Index (Thai ver.) after 14 days questionnaire
- Secondary Outcome Measures
Name Time Method liver function 14 days Siriraj's Clinical Pathology Laboratory ,kidney function 14 days Siriraj's Clinical Pathology Laboratory ,The World Health Organization Quality of Life (WHOQOL) -BREF 14 days questionnaire,Data consistency between sleep diary and wrist actigraph 14 days trend