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“Suk Sai-Yad” is the fourty-fourth traditional medicine recipe recorded in “the Royal Scripture of King
Narai’s Medicines”. This recipe contains 78 parts of 12 herbal ingredients, of which 12 parts are cannabis leaves as the main ingredient. Suk Sai-Yad was used as a panacea, analeptic, tonic, and sedative hypnotic. The objective of this study is aimed to evaluate the efficacy and safety of Suk Sai-Yad Recipe in OPD patients with insomnia who visited Hang-Ka-Rok medical cannabis clinic in Phra Arjarn Fhan Arjaro Hospital. This study is a prospective observational study conducted during June-December 2020 in 60 outpatients who were presented and diagnosed with insomnia, by a medical doctor and a Thai traditional medicine doctor, and were prescribed Suk Sai-Yad remedy for their treatment. The patients received Suk Sai-Yad powder (2 g) in aluminum foil packets to be taken by suspending ½-1 packet in water first or by mixing with a small amount of honey and taking as pill(s), once at bedtime for 4 weeks. Before taking the prescribed medication and on days 7, 14, 21, and 28 of the treatment, the insomnia condition, sleep quality, quality of life and health state of the patients were determined upon follow-ups using Thai version of the Pittsburgh Sleep Quality Index (T-PSQI) and EQ-5D-5L questionnaire, and any adverse drug reactions occurred after taking medication were recorded. It was found that 96.67% of the patients had improved insomnia condition after taking Suk Sai-Yad for 3-4 weeks. The average Pittsburgh Sleep Quality Index (PSQI) global score after taking Suk Sai-Yad (6.47 ± 1.90) was significantly lower than that before the treatment (14.13 ± 2.29) (p < 0.05). The top three PSQI component scores that decreased the most were 1) component 2 - sleep latency, 2) component 3 - sleep duration, and 3) component 4 – habitual sleep efficiency. The five dimensions (5D) quality of life and health state mean scores of the study group before taking the medicine were 0.821 ± 0.19 and 83.43 ± 14.07, respectively. After receiving four-week Suk Sai-Yad remedy, the 5D quality of life and health state mean scores significantly increased to 0.903 ± 0.11 (p = 0.036) and 89.27 ± 11.45 (p = 0.028), respectively. Three most commonly found non-serious adverse drug reactions were heartburn (21.67%), dizziness (5%) and dry mouth and throat (5%). In conclusion, the study showed that Suk Sai-Yad traditional medicine remedy at the dosage regimen used in this study was effective and safe to solve insomnia problem and helped improve the quality of life and health state of insomnia patients.
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