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

Effect of Pom-leung fever on Insomnia : A Double-blinded Randomized Controlled Trial.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240718004
Enrollment
100
Registered
2024-07-18
Start date
2023-08-09
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

who have sleep problems, can&#039

Interventions

4 capsule ac. (4 capsule Placebo) 4 capsule hs. (lorazepam (0.5) 1 capsule + 3 capsule placebo),4*2 ac. + hs. (500 mg/capsule)
Active Comparator Drug,Experimental Drug
lorazepam,Pom-lueng fever recipe

Sponsors

Department of Thai Traditional and Alternative Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
32 Years to 60 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
sleep quality at 1 months after end of the intervention Pittsburgh sleep Quality Index (PSQI)

Secondary

MeasureTime frame
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))

Countries

Thailand

Contacts

Public Contactsurasak imiam

Prapokklao hospital

surasak.alexx@gmail.com0894196695

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026