Kuppusamy Meera; Taib Tarita binti; Asmah Johar; Abdul Manan bin Mat Jais
Volume 19, Issue 3 , 2016, , Pages 67-72
Abstract
Background: Channa striatus or better known as the haruan fish is an indigenous, snakehead, striped, air breathing freshwater fish of Malaysia and has long been consumed traditionally during post-operative and post-partum period to speed recovery. Most medical properties of the haruan are contributed ...
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Background: Channa striatus or better known as the haruan fish is an indigenous, snakehead, striped, air breathing freshwater fish of Malaysia and has long been consumed traditionally during post-operative and post-partum period to speed recovery. Most medical properties of the haruan are contributed to its high content of essential fatty and amino acids. This was a phase I clinical trial to examine the safety of Channa striatus (CS) 5% cream with patch testing and cumulative dosing for up to 4 weeks on the healthy skin. Methods: This double-blind randomized controlled trial was conducted in two stages. Eighty-three participants who fulfilled the inclusion criteria underwent patch testing. The allergens, aqueous and CS 5% cream, were patch tested simultaneously but separately on each arm of the same participant. The participants with a negative patch test started stage 2, whereby they applied randomly assigned creams on both forearms for a duration of 1 month. Results: A total of 83 participants were screened successfully and underwent patch testing. One participant in the cohort developed a positive patch test to CS 5% and was excluded from stage 2. Two participants experienced mild side effects that resolved with mild topical steroid. The incidence of allergic contact dermatitis and irritant contact dermatitis was 1.2% and 2.4% in the participants, respectively. Conclusion: The uniquely Malaysian Channa striatus 5% cream has a good safety profile. Information on the safety and tolerability obtained from this study can be used to design larger phase II studies in patients with inflammatory skin conditions.
Nasrollahi Saman Ahmad; Hasanzadeh Hournaz; Ajami Marjan; Ameri Setareh; Variji Zeinab; Komeili Ali; Firooz Alireza
Volume 18, Issue 4 , 2015, , Pages 145-150
Abstract
Background: Cellulite is a common disease whose exact mechanism is unknown. This study was aimed to assess the safety and efficacy of an anti-cellulite preparation compared with placebo in a randomized double-blind, right-left comparison clinical trial.Methods: Twelve healthy women aged 22 to 58 years ...
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Background: Cellulite is a common disease whose exact mechanism is unknown. This study was aimed to assess the safety and efficacy of an anti-cellulite preparation compared with placebo in a randomized double-blind, right-left comparison clinical trial.Methods: Twelve healthy women aged 22 to 58 years with mild to moderate cellulite on their thighs and buttocks participated in this trial. The anti-cellulite preparation (Three O cream, Pouya Varzan Tejarat Sepahan Co., Iran) and an identical placebo were randomly applied on the right or left thigh and buttock twice a day for 2 months. The mentioned areas were photographed and the circumference, subcutaneous fat thickness, and dermis density and thickness were measured before and after treatment. A satisfaction questionnaire was completed by all volunteers to assess their satisfaction with the efficacy of treatment on each side.Results: There was no significant difference between active and placebo treatment sides in any of measurements. About 90% of participants had an overall satisfaction of 5 and more than 5 based on a 0 to 10 visual analogue scale on the side of anti-cellulite cream. This score was similar on the sides treated with placebo and the active product.Conclusion: Although Three O cream provided more satisfaction in volunteers than placebo, the objective measurements did not show any difference between them.