Efficacy and Safety of the Thamlai-Phra-Su-Men Formulation as an Adjunct to Thai Traditional Rehabilitation for Subacute Stroke: A Double-Blind Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260516004

Enrollment

Registered

2026-05-16

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

subacute stroke (within 3 months of onset) activities of daily living herbal medicine quality of life stroke rehabilitation Thai traditional medicine

Interventions

All participants received standard Thai traditional rehabilitation, consisting of royal-style Thai massage and herbal compress therapy, administered twice weekly for 10 weeks (21 sessions), with each

Experimental Drug,Placebo Comparator Drug

Tham lai Phra Su Men ,Placebo

Eligibility

Sex/Gender

All

Age

20 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients aged 20-70 years with motor weakness due to stroke and a motor power grade within the predefined range.

Exclusion criteria

Exclusion criteria: 1. Severe comorbid conditions 2. Unstable medical status 3. contraindications to herbal medicine or Thai traditional therapies

Design outcomes

Primary

Measure	Time frame
Motor function Session 1,11,21 motor power grading ,Neurological function Session 1,11,21 National Institutes of Health Stroke Scale (NIHSS)	—

Secondary

Measure	Time frame
Functional status Session 1,11,21 Barthel Activities of Daily Living (ADL) index,Health-related quality of life Session 1,11,21 EQ-5D-5L instrument,Participants overall perception Session 1,11,21 Patient Global Assessment	—

Countries

Thailand

Contacts

Public ContactNinnart Intharit

Naresuan University

ninnarti@nu.ac.th0956408744

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026