Improved participants' understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials.

PURPOSE: This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. METHODS: A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test. RESULTS: The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p < 0.001). CONCLUSIONS: The present study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.

Effects of Continuous Yoga on Body Composition in Obese Adolescents.

Overweight/obesity is a pressing international health concern, and conventional treatments demonstrate poor long-term efficacy. Several studies have shown that yoga can control risk factors for cardiovascular disease, obesity, and psychosocial stress. The present study aimed to assess the effect of continuous yoga (asanas, pranayama, and Surya Namaskar yoga) on body composition in overweight participants. Forty adolescents with obesity were enrolled in this study. The study was conceived as a prospective, single-center, single-blinded randomized controlled trial. The participants were divided into 2 groups: the intervention group (n = 20), which undertook a continuous yoga practice, and the control group (n = 20). Body composition, including body weight (BW), body mass index (BMI), body fat mass (BFM), and muscle mass, was evaluated using tetrapolar bioelectrical impedance (BIA). Our results showed that the mean BMI and BFM of the yoga intervention group were significantly decreased at week 8 and week 12. The muscle mass of the yoga group continued to improve at a rate of 0.515 per week, which was statistically significant. In conclusion, a continuous yoga practice had a tendency to decrease BMI and BFM and increase muscle mass. These findings demonstrate intervention effectiveness similar to that observed in other clinical research and indicate that continuous yoga practice may be used as an alternative therapy for obesity prevention and health promotion in adolescents with obesity.

Ginger extract versus Loratadine in the treatment of allergic rhinitis: a randomized controlled trial.

BACKGROUND: Allergic rhinitis (AR) is a non-infectious immune disease and incidents of the disease has continuously increased in Thailand. Ginger, a Thai herb, is used in food and Thai traditional medicine. This study was designed to assess efficacy and safety of ginger extract in comparison with loratadine for AR treatment. METHODS: AR patients were treated with ginger extract 500 mg (n = 40) against those treated with loratadine 10 mg (n = 40) in a randomized, double-blind, controlled trial for 3 and 6 weeks. The efficacy was evaluated from clinical examinations i.e. total nasal symptom scores (TNSS), cross-sectional area of the nasal cavity with acoustic rhinometry (ARM) and rhinoconjunctivitis quality of life questionnaire (RQLQ). The safety of treatment was measured by blood pressure, blood analysis and history-taking for side effects. RESULTS: The results showed both ginger extract and loratadine treated groups significantly decreased TNSS scores but there was no significant difference between the two groups. In acoustic rhinometry measurement, the ginger treated group significantly gradually increased the estimated volume of the nasal cavity and decreased distances from the nostril, but the loratadine treated group did not cause a change. Both groups gave significantly improvement in every aspect of the RQLQ at third weeks. The treatment with ginger extract was as safe as loratadine as shown by renal and liver function results obtained from blood analysis. Both treatments had no effect on blood pressure of the patients. CONCLUSIONS: The ginger extract is as good as loratadine in improving nasal symptoms and quality of life in AR patients. However, ginger extract caused less side effects especially, drowsiness, fatigue, dizziness and constipation. Therefore, the ginger extract could be used as alternative treatment for patients with AR. TRIAL REGISTRATION: Registered with ClinicalTrials.gov (Registration number: NCT02576808) on 15 October 2015.