Effect of a novel herbal and nutritional supplement for pain management in chronic pai

Not Applicable

Completed

• Conditions: chronic non-cancer pain; Neurological - Other neurological disorders; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12621000228886
• Lead Sponsor: Integria Healthcare (Australia) Pty Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-04
• Study Completion: 2022-05-18
• Last Update Posted: 27 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Participants meeting the following criteria to be included in the study:
- Adults with chronic pain – defined as persistent pain for 12 weeks or more.
- Average pain score of 4 or >4 on the visual analogue scale (0-10) for related pain intensity in 3-day diary.

Exclusion Criteria

Participants meeting the following criteria to be excluded from the study:
- Diagnosed with any of the following medical conditions: neurological disease, gallstones or bile duct obstruction, cancer, currently unwell with acute infection or fever.
- Cause of chronic pain is related to a hormonal condition such as menstrual pain or endometriosis, or is autoimmune in nature.
- Currently experiencing acute pain unrelated to chronic pain.
- In poor general health or baseline blood tests shows abnormal results that require further investigation (as evaluated by PI).
- Taking any of the following medications: anti-platelet or anti-coagulant medication, steroids, turmeric or curcumin or PEA supplements, within previous four weeks.
- Taking any herbal or nutritional supplements, unless consistently taking for four weeks or more and planning to continue with them throughout the study. Patients with inconsistent use may choose to stop taking the supplements and be re-evaluated for study entry after one week.
- Pregnancy, planned pregnancy, or currently breastfeeding.
- Planned surgery within two months.
- Allergy/sensitivity to study drugs or their formulations.
- Individuals that have participated in another clinical trial in the last 30 days.
- Inability or unwillingness of subject or legally acceptable representative to give written informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference between treatment groups in average weekly pain intensity, measured on a visual analogue scale[From baseline to 8 weeks post intervention commencement, assessed daily through pain management app. ]