The Study of Effectiveness of Zingiber cassumunar Roxb.(Plai) Mixed Cannabis sativa L. Leaf Oil for Chronic Pain in Elderly.Randomized controlled trial

Effectiveness of Plai mixed Cannabis Leaf Oil for the treatment of chronic pain in elderly patients. : a double-blind randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20231014005

Enrollment

Registered

2023-10-14

Start date

2022-06-15

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Chronic pain in the elderly Cannabis sativa Zingiber cassumunar Cannabis leaf Elderly Randomized controlled trial Non-inferiority trial

Interventions

SPRAY DICLOFENAC DIETHYLAMMONIUM 1.16 G Reg No 1A 76/47,Zingiber cassumunar Roxb.(Plai) Mixed Cannabis sativa L. Leaf Oil.Extemporaneous preparation manufactured by Thai traditional medicine in Wanon

Active Comparator Drug,Experimental Drug

Control group,Treatment group

Eligibility

Sex/Gender

All

Age

60 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Who signed the consent form and were pleased to cooperate with this research. 2.60 to 75 years old. 3.Who have neck and shoulder pain or back pain duration of pain for 3 months or over. 4.Numerical pain rating scale (NPRS) score of 4 or more. 5.Do not receive NSAIDs 48 hours before and did not use them during the study. 6.Do not receive cannabis drugs the 1 week before and did not use them during the study. 7.Do not receive the topical anesthetics 48 hours before and did not use them during the study. 8.No other treatment for pain relief 24 hours before and not to receive other treatment except as received by the investigator. 9.No underlying disease causes chronic pain such as cancer, rheumatoid arthritis, etc. No cannabis allergy, plai, and coconut oil. 10. No Diclofenac allergy or serious allergic reactions to NSAIDs. 11.No asthma disease, gastrointestinal (GI) bleeding, hepatic or renal insufficiency. 12. Do not receive warfarin.

Exclusion criteria

Exclusion criteria: 1.Can not follow up on treatment at least once. 2.Patients do not want to continue taking the drug or want to receive other treatments. 3.Patients have adverse drug reactions.

Design outcomes

Primary

Measure	Time frame
numeric pain rating scale (NPRS) 0, 30 mins, 1 days, 3 days, 7 days and 14 days numeric pain rating scale (NPRS)	—

Secondary

Measure	Time frame
Do not have Secondary Outcome Do not have Secondary Outcome Do not have Secondary Outcome	—

Countries

Thailand

Contacts

Public ContactMathawee Luplipon

Faculty of Public Health, Kasetsart University Chalermphrakiat Sakon Nakhon Province Campus

Mathawee.l@ku.th0645196997

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026