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The Clinical Efficacy And Safety Of Thai Traditional Medicine Remedy Call Kae Lom Kae Sen For Upper Back Pain Reliving Compared With Diclofenac And Placebo.

The Clinical efficacy and safety of Thai traditional medicine remedy call Kae Lom Kae Sen for upper back pain reliving compared with diclofenac and placebo

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250618001
Enrollment
90
Registered
2025-06-18
Start date
2024-01-15
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

Upper Back Pain Upper Back Pain

Interventions

Participants will take 2 capsules per dose, twice a day (in the morning and evening), before meals.,Participants will take 1 capsule per dose, three times a day (morning, noon, and evening), after mea
Kae Lom Kae Sen,Diclofenac ,Placebo

Sponsors

Department of Thai Traditional and Alternative Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Male and female participants aged between 25 and 60 years. 2. Have undergone history taking, physical examination, and been diagnosed with unilateral or bilateral shoulder or neck muscle pain lasting continuously for 2 to 30 days (acute upper back pain) by a Thai traditional medicine practitioner and/or a conventional medical doctor. 3. Have a pain score of 3 or higher measured by the Numerical Rating Scale (NRS). 4. Are fully conscious and oriented, able to read, write, and communicate in Thai. 5. Are able to follow the research procedures and attend appointments at the Thai Traditional and Integrative Medicine Hospital, Department of Thai Traditional and Alternative Medicine, on their own. 6. Are willing to follow instructions and voluntarily consent to participate in the research study.

Exclusion criteria

Exclusion criteria: 1. Have shoulder and neck pain accompanied by other conditions such as shoulder joint inflammation, frozen shoulder, cervical spondylosis, or herniated disc with nerve compression. 2. Have restricted movement due to joint deformities or scoliosis. 3. Have contagious diseases such as active tuberculosis, contagious skin conditions, or are currently under treatment for or infected with COVID-19. 4. Have undergone surgery for cervical spondylosis or herniated disc conditions within the past 6 months. 5. Have high blood pressure exceeding 140/90 mmHg. 6. Have a fever (body temperature over 38 C). 7. Are pregnant, breastfeeding, or planning to conceive. 8. Are currently menstruating. 9. Have a history of allergy to cannabis, pepper, or non-steroidal anti-inflammatory drugs (NSAIDs). 10. Have laboratory results, medical history, or chronic conditions that may be dangerous or lead to serious adverse effects from the medication, including liver disease, kidney disease, peptic ulcer gastric/ulcer, heart disease, or psychiatric disorders. 11. Are currently using other pain medications, cannabis products, receiving therapeutic massage, physical therapy, acupuncture, or other treatments these must be stopped at least 5 days prior to participation. 12. Are currently participating in another research study.

Design outcomes

Primary

MeasureTime frame
measuring pain level days 0, 3 and 7 Numeric Rating Scale (NRS)

Secondary

MeasureTime frame
complete blood count (CBC) days 0 and 7 Complete blood count,renal function days 0 and 7 Serum Creatinine,liver function days 0 and 7 liver function test,cervical range of motion (CROM) of the shoulder and neck muscles days 0, 3 and 7 Cervical Range of Motion Instrument,pressure pain threshold (PPT) using an algometer days 0, 3 and 7 Algometer,serum Substance P levels days 0 and 7 Blood test

Countries

Thailand

Contacts

Public ContactPiyatas Jaiyen

Thai Traditional and Integrative Medicine Hospital

smerosd@gmail.com0835776234

Outcome results

None listed

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