Efficacy and Safety of Samran Nithra, a Thai Traditional Medicine Formula, for the Relief of Insomnia

Abstract

Introduction and Objective: Currently, around 19 million people in Thailand suffer from insomnia, leading to the efforts to encourage the use of Thai herbal formula as a choice to help with sleep problems. “Samran Nithra” is a TTM formula, listed in the classical TTM textbook called “Veja Suksa of Phraya Phitsanu Prasartvej” Volume 1, containing cannabis inflorescence as one of 19 herbal ingredients. It has been prescribed for the relief of insomnia, wind-related problems, and loss of appetite at Thai Traditional and Complementary Medicine Hospital (TTCMH). However, no clinical study on this herbal formula has yet been reported. This study was therefore conducted to evaluate the efficacy and safety of Samran Nithra formula in patients with insomnia who are being treated at the TTCMH.

Methods: This study was a quasi-experimental, single-group pretest-posttest design. Forty-five participants were purposively selected from patients seeking treatment for insomnia at TTCMH between May 15 to August 15, 2024. Prior to receiving the investigational drug (Day 0), the researcher collected: 1) demographic data, 2) sleep data, and 3) sleep quality data (using the Thai version of the Pittsburgh Sleep Quality Index: PSQI). Subsequently, study participants received 250 mg capsules of Samran Nithra formulation, to be taken at the dose of one capsule, once daily at bedtime, for 4 weeks. On Day 14, participants were followed up for any adverse events (if any) via telephone. Following drug administration (Day 29), participants were followed-up and evaluated for: sleep data, sleep quality data (using the Thai PSQI), safety data in case of adverse events during drug use, utilizing Adverse Event Reporting Form for Health Products of Thai FDA. The causality of adverse drug reactions was assessed using the Naranjo's algorithm. Medication adherence was evaluated by pill counting. Statistical data analysis was performed using descriptive statistics or paired t-test, statistical significance level was set at p < 0.05.

Results: Demographic data showed that the participants were mostly female (62.22%), had an average age of 57.58 ± 9.91 years, with hypertension and hyperlipidemia as the most common underlying conditions (both at 29.63%). Insomnia was present for a duration of 1 week to 1 month and more than 1 year in 53.33% and 35.56% of the participants, respectively. Sleep data indicated that before receiving the Samran Nithra formulation, most patients (82.22%) had a sleep latency (time from going to bed to actually falling asleep) of 30–60 minutes. After receiving the drug, this group decreased to 37.78%, with most patients (55.56%) reporting a sleep latency of less than 30 minutes. In terms of sleep quality as measured by PSQI, the mean total PSQI score before receiving the Samran Nithra formulation was 16.16 + 4.42, after 4 weeks of treatment, the mean total PSQI score was significantly lower to 4.09 + 3.48 (p < 0.001). All seven components of the PSQI also showed a statistically significant reduction (p < 0.001). For safety, no adverse events were observed during 4-week administration of the Samran Nithra formulation.

Discussion: Samran Nithra formulation demonstrated efficacy in promoting sleep or alleviating symptoms of insomnia. Every component of sleep quality improved, most notably, a reduction in sleep latency, an increase in total sleep duration, a decrease in sleep disturbances, and an improvement in sleep efficiency. Our findings are consistent with previous studies, including, the study on Ajarn Decha's cannabis oil formula conducted by Kanyapak Silarak at Phra Arjarn Phan Arjaro Hospital, the research on cannabis extract by Suwanna Arunpongpaisal, the study by Sarunya Khongying on a traditional formula with components similar to the Samran Nithra formulation, and the research by Sasipong Tipratchadaporn on the Suk Sai-Yad formulation.

Conclusion and Recommendations: This study found that Samran Nithra formulation demonstrated efficacy in promoting sleep. However, as this was a quasi-experimental study utilizing a single-group design, a Randomized Controlled Trial (RCT) is recommended for future research to confirm the efficacy and safety of Samran Nithra formula which may then serve as a new therapeutic option for the treatment of insomnia.