The Efficacy of CALPXT96™in Improving Sleep Quality in Patients With Chronic Non-cancer Pain
Status:
Withdrawn
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
California Poppy has been traditionally used in Herbal Medicine as an analgesic, mild
sedative and/or sleep aid. However there are no human clinical trial data to support its use.
Sleep disturbances are a well-recognized component of chronic pain, and lead to additional
social withdrawal, greater pain and worsening depression. Most hypnotics available either
place the patient at further risk (e.g. benzodiazepines combined with opioids increase the
risk of central or obstructive sleep apnea), increase adverse events (dry mouth, daytime
somnolence, etc.) or induce sleep but do not improve the quality of sleep (no increase in
Rapid Eye Movement or curative sleep). This study intends to use California Poppy to avoid
adverse effects while improving sleep. An open-label clinical trial was performed to obtain
preliminary safety and efficacy information of California poppy. This trial was approved by a
central ethics review board. The study results showed that California poppy, can be used as a
co-analgesic to provide additional analgesia and/or sleep improvement to the patient.
Patients who are referred to the clinic will be asked to complete a few short questionnaires
at every visit and on monthly basis respectively. This data, in addition to the usual
follow-up questionnaires used by the clinics' physicians (McGill Pain Intensity, Pain
Disability Index, Short-form Health Survey-12v2) and general demographic and medical
information will be used to assess California Poppy's effectiveness on patients