OBJECTIVES: In this study, Chromolaena odorata gel and quercetin gel (bioactive flavonoid compound) were successfully formulated and compared with placebo and conventional wound aid gel. The chromatographic profilling was conducted to screen the presence of phytoconstituents. Subsequently, all formulated gels were subjected to physical characteristic and stability study.
METHODS: Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) of C.odorata methanolic leaves extract shows a distinct compound separation at retention time 8.4min to 34.8 min at 254nm. All gels were characterised by evaluating their rheological properties including storage modulus, loss modulus and plastic viscosity. Besides, texture analysis was performed to measure the gels' firmness, consistency, cohesiveness, and viscosity index.
RESULTS: From the observation, C. odorata gel demonstrated better spreadability as compared to the other gels, which acquired less work and favourable to be applied onto the skin. Moreover, C. odorata gel showed no changes in organoleptic properties and proven to be stable after 30 days of accelerated stability study at 40°C ± 2°C with relative humidity (RH) of 75%± 5%.
CONCLUSION: C. odorata gel has shown to be stable, reflecting the combination of materials used in the formulation, which did not degrade throughout the study. This work suggests the potential of this gel as a vehicle to deliver the active ingredients of C. odorata to the skin, which can be further explored as a topical application in antimicrobial wound management or other skin diseases study.
METHOD: We enrolled 95 women (≥ 36 weeks gestation) on their attendance for planned ECV. All participants received terbutaline tocolysis. Regional anaesthesia was not used. ECV was performed in the standard fashion after the application of the allocated aid. If the first round (maximum of 2 attempts) of ECV failed, crossover to the opposing aid was permitted.
RESULTS: 48 women were randomised to powder and 47 to gel. Self-reported procedure related median [interquartile range] pain scores (using a 10-point visual numerical rating scale VNRS; low score more pain) were 6 [5-9] vs. 8 [7-9] P = 0.03 in favor of gel. ECV was successful in 21/48 (43.8%) vs. 26/47 (55.3%) RR 0.6 95% CI 0.3-1.4 P = 0.3 for powder and gel arms respectively. Crossover to the opposing aid and a second round of ECV was performed in 13/27 (48.1%) following initial failure with powder and 4/21 (19%) after failure with gel (RR 3.9 95% CI 1.0-15 P = 0.07). ECV success rate was 5/13 (38.5%) vs. 1/4 (25%) P = 0.99 after crossover use of gel or powder respectively. Operators reported higher satisfaction score with the use of gel (high score, greater satisfaction) VNRS scores 6 [4.25-8] vs 8 [7-9] P = 0.01.
CONCLUSION: Women find gel use to be associated with less pain. The ECV success rate is not significantly different.
TRIAL REGISTRATION: The trial is registered with ISRCTN (identifier ISRCTN87231556).