Therapeutic efficacy and safety of traditional Thai herbal medicines for insomnia: a double-blind randomized controlled trial

Phase 2

Completed

• Conditions: insomnia; Yahom-Navakot; Suk-Sai-Yat

• Registration Number: TCTR20240528004
• Lead Sponsor: Faculty of Traditional Thai Medicine

Brief Summary

Yahom-Navakot was significantly effective in improving sleep quality including sleep quality, sleep latency, sleep duration, sleep efficiency, and daytime dysfunction, compared to Suk-Sai-Yat.

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-08-28
• Study Start: 2024-05-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

1. aged 18-60 years
2. patients had PSQI score more than or equal 5, indicating poor sleep quality
3. patients voluntarily participated in the study and signed the informed consent form

Exclusion Criteria

1. patients with uncontrolled systemic illness or life-threatening infection
2. patients who had already undergoing treatment for any chronic disease, substance abuse and/or dependence, pregnant or lactating women
3. patients with psychiatric diseases and self-reported immune-compromised states
4. patients who had allergic history to any Thai herbal medicines.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sleep quality, daytime sleepiness, and quality of life 4 weeks Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and Health-Related Quality of Life Measure (EQ-5D)

Secondary Outcome Measures

Name	Time	Method
adverse drug reactions 4 weeks adverse drug reactions form