Clinical study of traditional recipe/Pom-leung fever in patient with insomnia

Phase 3

Completed

• Conditions: who have sleep problems, can' t sleep, can' t sleep well. and has been awake while sleeping for at least 1 month with a PSQI score of more than 5 points; insomnia, sleep problem, herbal, recipes, cannabis

• Registration Number: TCTR20240718004
• Lead Sponsor: Department of Thai Traditional and Alternative Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-05-08
• Study Start: 2024-07-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

1. male or female with 32-60 year
2. who have sleep problems, can't sleep, can't sleep well. and has been awake while sleeping for at least 1 month with a PSQI score of more than 5 points.
3. eGFR > 60 mL/min
AST < 105, ALT < 150
Hb > 10 g/dL
4. women with negative urine pregnancy test
5. Be voluntary and willing to participate in the project Along with signing the consent form to participate.

Exclusion Criteria

1. abnormal liver and kidnye
2. Patients with cardiovascular disease High blood pressure, GERD, taking anticoagulants/warfarin/aspirin/clopidogrel/and Blood pressure medicine
3. patient use Phenytoin, Propranolol, Theophylline or Rifampicin
4. Have a history of allergic reactions to herbal medicines People who have used during 2 weeks herbs that contain cannabis herbs or other herbs that affect sleep
5. Other procedures that affect sleep, such as acupuncture or other treatments.
6. People who drank alcohol in the 1 month before joining the project and while participating in the project
7. People with a history of drug use
8. Pregnant woman breastfeeding woman

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sleep quality at 1 months after end of the intervention Pittsburgh sleep Quality Index (PSQI)

Secondary Outcome Measures

Name	Time	Method
Quality of life at 1 months after end of the intervention Thai Pictorial Quality of lift: PTQL,stress at 1 months after end of the intervention ST-5: Stress Test Questionnaire,side effect at 1 months after end of the intervention labatory (CBC, Bun, Cr, LFT, Uric acid, Lipid profile, EKG))