The Effect of Dietary Supplementation of Crocetin for Myopia Control in Children: A Randomized Clinical Trial

The prevalence of myopia has been increasing in recent years. The natural carotenoid crocetin has been reported to suppress experimental myopia in mice. We evaluated the effects of crocetin on myopia suppression in children. A multicenter randomized double-blind placebo-controlled clinical trial was performed with 69 participants aged 6 to 12 years, whose cycloplegic spherical equivalent refractions (SER) were between −1.5 and −4.5 diopter (D). The participants were randomized to receive either a placebo or crocetin and followed up for 24 weeks. Axial length (AL) elongation and changes in SER were evaluated for 24 weeks. Both written informed assent from the participants and written informed consent from legal guardians were obtained in this study because the selection criteria of this trial included children aged between 6 and 12 years old. This trial was approved by the institutional review boards. A mixed-effects model was used for analysis, using both eyes. Two participants dropped out and 67 children completed this trial. The change in SER in the placebo group, −0.41 ± 0.05 D (mean ± standard deviation), was significantly more myopic compared to that in the crocetin group, −0.33 ± 0.05 D (p = 0.049). The AL elongation in the placebo group, 0.21 ± 0.02 mm, was significantly bigger than that in the crocetin group, 0.18 ± 0.02 mm (p = 0.046). In conclusion, dietary crocetin may have a suppressive effect on myopia progression in children, but large-scale studies are required in order to confirm this effect.

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The Effects of Clomipramine Hydrochloride in Cats With Psychogenic Alopecia: A Prospective Study

Journal of the American Animal Hospital Association ◽

10.5326/0420336 ◽

2006 ◽

Vol 42 (5) ◽

pp. 336-343 ◽

Cited By ~ 7

Author(s):

Petra A. Mertens ◽

Sheila Torres ◽

Carl Jessen

Keyword(s):

Clinical Trial ◽

Prospective Study ◽

Treatment Duration ◽

Drug Efficacy ◽

Controlled Clinical Trial ◽

Double Blind ◽

Double Blind Placebo ◽

A Prospective Study ◽

To Receive ◽

Insufficient Number

A double-blind, placebo-controlled clinical trial was conducted to determine the efficacy of clomipramine hydrochloride in cats with psychogenic alopecia. Twenty-five cats were randomly assigned to receive clomipramine hydrochloride (0.5 mg/kg orally q 24 hours) or placebo for 56 days. Eleven cats in each group completed the trial. The results of this study showed that clomipramine hydrochloride failed to demonstrate significant changes in the number of grooming bouts, hair regrowth, and the area of alopecia in cats with psychogenic alopecia when compared to a placebo. It was uncertain whether these results reflected a lack of drug efficacy, insufficient treatment duration, or an insufficient number of cases enrolled.

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OscillococcinumR in patients with influenza-like syndromes: A placebo-controlled double-blind evaluation

British Homeopathic Journal ◽

10.1054/homp.1999.0208 ◽

1998 ◽

Vol 87 (02) ◽

pp. 69-76 ◽

Cited By ~ 39

Author(s):

Rosemarie Papp ◽

Gert Schuback ◽

Elmar Beck ◽

Georg Burkard ◽

Jürgen Bengel ◽

...

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Rectal Temperature ◽

Muscle Pain ◽

Rating Scale ◽

Controlled Clinical Trial ◽

Double Blind ◽

Duration Of Symptoms ◽

Number Of Patients ◽

Positive Effect

AbstractA controlled clinical trial was conducted to assess the effectiveness of OscillococcinumR in the treatment of patients with influenza-like syndromes. 188 patients received the test drug and 184 patients were assigned to the placebo. Data were recorded by the participating physicians at the beginning of the treatment, after 48 hours and after 7–10 days. During the first few days, the patients recorded their rectal temperature twice a day (mornings and evenings), 9 symptoms on a rating scale (cough, catarrh, sore throat, muscle pain, etc.), and use of medication. Recovery was defined as follows: ‘rectal temperature < 37.5°C and no headache or muscle pain’. Effectiveness was defined as a statistically significant greater decrease in symptoms after 48 hours in the verum group or a shorter duration of symptoms in comparison to the placebo group. After 48 hours the symptoms of the patients in the verum group were significantly milder (P=0.023) than in the placebo group. The number of patients with no symptoms was significantly higher in the verum group from the second day onwards (verum: 17.4%, placebo: 6.6%) until the end of the patients’ recording (day 5 in the evening: verum: 73.7%, placebo: 67.7%). The biggest group difference was recorded for the time between the evening of the second day (10.6% more patients with no symptoms) and the morning of the fourth day (10.2% more patients with no symptoms). The clinical trial showed that treatment of influenza-like syndromes with OscillococcinumR has a positive effect on the decline of symptoms and on the duration of the disease.

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Efficacy of Matricaria chamomilla L. in Infantile Colic: A Double Blind, Placebo Controlled Randomized Trial

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2019/v31i630385 ◽

2020 ◽

pp. 1-11

Author(s):

Fatemeh Mohamadi Sorme ◽

Malihe Tabarra ◽

Hosein Alimadady ◽

Roja Rahimi ◽

Mahdi Sepidarkish ◽

...

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Infantile Colic ◽

Matricaria Chamomilla ◽

Double Blind ◽

Serious Adverse Event ◽

Double Blind Placebo ◽

Common Problems ◽

To Receive ◽

Delivery Type

Objective: Infantile colic is one of the most common problems in neonatal and early infancy, the prevalence of which has been reported as 10-20%. The present clinical trial was conducted to investigate whether topical use of chamomile oil reduces crying and fussing in breastfed colicky infants. Methods: A total of 102 breastfed colicky infants were divided into two groups to receive topical chamomile or placebo oil 6 times a day for 7 days. Both groups also received 5 mg of Simethicone syrup 4 times a day. Parents reported on crying and fussing duration, exertion times and side effects using a questionnaire. Results: 90 babies could complete the trial including 47 patients in chamomile group and 43 patients in the placebo group. Babies in both groups were the same in terms of gestational age, birth weight, birth order, gender, delivery type, crying and fussing on the day before the treatment. At the end of the study, crying and fussing was found to be lower in chamomile group than the placebo group (p <0.001). Also, 39 and 27 patients responded to the treatment in chamomile and placebo groups respectively. The effect of chamomile oil on crying (p<0.01) and fussing (p< 0.001) was significant. No serious adverse event was reported. Conclusion: Results revealed that chamomile oil reduced symptoms in breastfed colicky infants compared to the infants in the placebo group. This suggests that topical use of chamomile oil may be effective in the treatment of colic.

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Safety and immunogenicity of anti-SARS CoV-2 conjugate vaccine SOBERANA 02 in a two-dose or three-dose heterologous scheme in adults: Phase IIb Clinical Trial

10.1101/2022.01.01.21268271 ◽

2022 ◽

Author(s):

Maria Eugenia-Toledo-Romani ◽

Mayra Garcia-Carmenate ◽

Leslyhana Verdecia-Sanchez ◽

Suzel Perez-Rodriguez ◽

Meybis Rodriguez-Gonzalez ◽

...

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Neutralizing Antibodies ◽

Seroconversion Rate ◽

Serious Adverse Events ◽

Double Blind ◽

The Third ◽

Functional Antibodies ◽

Dose Trial ◽

To Receive

Background: We report results of immunogenicity, safety and reactogenicity of SOBERANA 02 in a two-dose or three-dose heterologous scheme in adults in a phase IIb clinical trial. Method: This phase IIb trial was designed as parallel, multicentre, adaptive, double blind, randomized and placebo-controlled. Subjects (N=810) aged 19-80 years were randomized to receive two doses of the recombinant SARS CoV-2 receptor binding domain (RBD) conjugated to tetanus toxoid (SOBERANA 02) and a third dose of dimeric RBD (SOBERANA Plus) 28 days apart; two production batches of active ingredient of SOBERANA 02 were evaluated. Primary outcome was the percentage of seroconverted subjects with ≥4-fold the anti-RBD IgG concentration. Secondary outcomes were safety, reactogenicity and neutralizing antibodies. Results: Seroconversion rate in vaccinees was respectively 76.3 and 96.8% after two or three doses, compared with 7.3% in placebo group. Anti-RBD IgG increased significantly after first and second dose of SOBERANA 02 respect to placebo group; and the third dose with SOBERANA Plus boosts the response compared to the second dose. Neutralizing IgG antibodies were detected against D614G and VOCs α, β and δ. Specific and functional antibodies were detected until 7-8 months after the third dose. The frequency of serious adverse events (AEs) associated with vaccination was very low (0.1%); with only one serious AE consistent with vaccination. Local pain was the most frequent AE. Conclusions: Two doses of SOBERANA 02 were well tolerated, safe an immunogenic in adults aged 19-80 years old. The heterologous combination with a third dose of SOBERANA Plus increased neutralizing antibodies, detectable 7-8 months after the third dose. Trial registry: https://rpcec.sld.cu/trials/RPCEC00000347

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Ingestion of a THC-Rich Cannabis Oil in People with Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Pain Medicine ◽

10.1093/pm/pnaa303 ◽

2020 ◽

Vol 21 (10) ◽

pp. 2212-2218

Author(s):

Carolina Chaves ◽

Paulo Cesar T Bittencourt ◽

Andreia Pelegrini

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Placebo Group ◽

Low Cost ◽

Fibromyalgia Impact Questionnaire ◽

Health Condition ◽

Depression Score ◽

Controlled Clinical Trial ◽

Double Blind

Abstract Objective To determine the benefit of a tetrahydrocannabinol (THC)-rich cannabis oil on symptoms and quality of life of fibromyalgia patients. Methods A double-blind, randomized, placebo-controlled clinical trial was conducted for eight weeks to determine the benefit of a THC-rich cannabis oil (24.44 mg/mL of THC and 0.51 mg/mL of cannabidiol [CBD]) on symptoms and quality of life of 17 women with fibromyalgia, residents of a neighborhood with a low socioeconomic profile and a high incidence of violence in the city of Florianopolis, Brazil. The initial dose was one drop (∼1.22 mg of THC and 0.02 mg of CBD) a day with subsequent increases according to symptoms. The Fibromyalgia Impact Questionnaire (FIQ) was applied at pre- and postintervention moments and in five visits over eight weeks. Results There were no significant differences on baseline FIQ score between groups. However, after the intervention, the cannabis group presented a significant decrease in FIQ score in comparison with the placebo group (P = 0.005) and in comparison with cannabis group baseline score. (P < 0.001). Analyzing isolated items on the FIQ, the cannabis group presented significant improvement on the “feel good,” “pain,” “do work,” and “fatigue” scores. The placebo group presented significant improvement on the “depression” score after intervention. There were no intolerable adverse effects. Conclusions Phytocannabinoids can be a low-cost and well-tolerated therapy to reduce symptoms and increase the quality of life of patients with fibromyalgia. Future studies are still needed to assess long-term benefits, and studies with different varieties of cannabinoids associated with a washout period must be done to enhance our knowledge of cannabis action in this health condition.

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Evaluation of a nutritional supplement for the alleviation of pain associated with feline degenerative joint disease: a prospective, randomized, stratified, double-blind, placebo-controlled clinical trial

Journal of Feline Medicine and Surgery ◽

10.1177/1098612x211053484 ◽

2021 ◽

pp. 1098612X2110534

Author(s):

Rachael Cunningham ◽

Margaret E Gruen ◽

Andrea Thomson ◽

B Duncan X Lascelles

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Chondroitin Sulfate ◽

Outcome Measures ◽

Nutritional Supplement ◽

Degenerative Joint Disease ◽

Joint Disease ◽

Controlled Clinical Trial ◽

Double Blind ◽

Double Blind Placebo

Objectives The purpose of this study was to evaluate the pain-alleviating and activity-enhancing effects of glucosamine/chondroitin sulfate (Dasuquin) in cats that had degenerative joint disease (DJD) and owner-noted mobility/activity impairment. We hypothesized that the nutritional supplement would produce pain-relieving and activity-enhancing effects in cats with painful DJD. Methods In this prospective, randomized, stratified, double-blind, placebo-controlled clinical trial, 59 cats with DJD pain were assigned to receive a placebo (n = 30) or supplement (n = 29) for 6 weeks after 2 weeks of placebo. Outcome measures (at-home accelerometry and client-specific outcome measures [feline (CSOMf); Feline Musculoskeletal Pain Index (FMPI); quality of life (QoL)]; and veterinarian examination) were collected at days 14, 28, 42 and 56. Results Twenty-seven cats in the treatment group and 30 in the placebo group completed the trial. Within the first 2 weeks (placebo administration to all cats), 78% of all cats had an improvement in CSOMf scores. Both groups showed significant improvement at most time points in CSOMf, FMPI, QoL and pain scores, with the placebo group showing greater improvement than the supplement group (significant for CSOMf [ P = 0.01]). Overall, no differences in activity were seen between the groups. Cumulative distribution function analysis indicated that for most levels of activity, the placebo-treated cats were more active; however, the least active cats were more active on the supplement ( P = 0.013). Conclusions and relevance This study showed a strong placebo effect. The glucosamine/chondroitin sulfate supplement did not show pain-relieving effects when compared with placebo.

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A Clinical Trial to Investigate the Effect of Cynatine HNS on Hair and Nail Parameters

The Scientific World JOURNAL ◽

10.1155/2014/641723 ◽

2014 ◽

Vol 2014 ◽

pp. 1-6 ◽

Cited By ~ 3

Author(s):

Christina Beer ◽

Simon Wood ◽

Robert H. Veghte

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Amino Acid ◽

Hair Loss ◽

Hair Growth ◽

Controlled Clinical Trial ◽

Double Blind ◽

End Points ◽

Double Blind Placebo ◽

New Novel

Objective. A new, novel product, Cynatine HNS, was evaluated for its effects as a supplement for improving various aspects of hair and nails in a randomized, double-blind, placebo-controlled clinical trial.Methods. A total of 50 females were included and randomized into two groups. The active group (n=25) received 2 capsules containing Cynatine HNS, comprised of Cynatine brand keratin (500 mg) plus vitamins and minerals, per day, and the placebo group (n=25) received 2 identical capsules of maltodextrin per day for 90 days. End points for hair loss, hair growth, hair strength, amino acid composition, and hair luster were measured. End points were also measured for nail strength and the appearance of nails.Results. The results show that subjects taking Cynatine HNS showed statistically significant improvements in their hair and nails when compared to placebo.Conclusion. Cynatine HNS is an effective supplement for improving hair and nails in 90 days or less. EudraCT number is 2014-002645-22.

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Effectiveness and Safety of Panax ginseng Extract on Hepatic Dysfunction: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/2689565 ◽

2020 ◽

Vol 2020 ◽

pp. 1-8

Author(s):

Lei Shen ◽

Si Ra Gwak ◽

Jong Cheon Joo ◽

Bong Keun Song ◽

Seon Woo Cha ◽

...

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Panax Ginseng ◽

Hepatic Dysfunction ◽

Controlled Clinical Trial ◽

Gamma Glutamyl Transferase ◽

Double Blind ◽

Ginseng Extract ◽

Double Blind Placebo ◽

Glutamyl Transferase

Background. The purpose of this study was to evaluate the efficacy and safety of Panax ginseng extract (GS-KG9) in the treatment of hepatic dysfunction. Methods. A randomized, double-blind, placebo-controlled clinical trial was conducted from December 2017 to January 2019. The trial included 60 subjects between the ages of 19 and 70 who had higher alanine transaminase (ALT) levels than the normal upper limit. The subjects were randomly divided into two groups: GS-KG9 (n = 30) and placebo (n = 30). The former was administered three GS-KG9 capsules (3 g/day) and the latter three placebo capsules (3 g/day) twice each day orally after meals in the morning and evening for 12 weeks. The primary goal was to observe the changes in ALT and gamma-glutamyl transferase (GGT) levels. The safety of the treatment was assessed and adverse events (AEs) were recorded. Results. Out of 60 subjects, nine were excluded from the efficacy analysis because they met the exclusion criteria. Therefore, a total of 51 subjects were evaluated for the effectiveness of the treatment (26 in the GS-KG9 group and 25 in the placebo group). After 12 weeks of treatment, the ALT levels were significantly reduced in the GS-KG9 group compared to the placebo group (p=0.009). The GGT level of the GS-KG9 group was significantly lower than that of the placebo group (p=0.036). Mild AEs, such as diarrhea, occurred during the study. There were no significant differences between the two groups. Conclusion. The results of this trial suggest that GS-KG9 might be an effective and safe option for mild hepatic dysfunction. This trial is registered with KCT0004080.

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Evaluation of the Effectiveness of the Iralvex Gel on the Recurrent Aphthous Stomatitis Management

International Scholarly Research Notices ◽

10.1155/2014/175378 ◽

2014 ◽

Vol 2014 ◽

pp. 1-5 ◽

Cited By ~ 2

Author(s):

Heidar Khademi ◽

Pedram Iranmanesh ◽

Ali Moeini ◽

Atefeh Tavangar

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Complete Healing ◽

Recurrent Aphthous Stomatitis ◽

Aphthous Stomatitis ◽

The Other ◽

Definitive Treatment ◽

Controlled Clinical Trial ◽

Double Blind ◽

Pain Duration

Introduction. As there is no definitive treatment for the recurrent aphthous stomatitis (RAS), most of the available therapies aim at decreasing pain and discomfort. The aim of this study was to investigate the effectiveness of the Iralvex gel on the RAS management. Material and Methods. In this double-blind and placebo-controlled clinical trial study, twenty patients were treated with the Iralvex gel and the other twenty patients were treated with placebo. In every participant complete healing of lesions, pain duration, and intensity were evaluated. Data were analyzed by independent t-test and analysis of variance. Results. Pain was relieved after 6.10 ± 0.29 days in the Iralvex group in comparison to 8.00 ± 0.33 days in the placebo group (P value ≤0.001). Complete remission in the Iralvex group was after 6.80 ± 0.27 days and 10.20 ± 0.42 days in the placebo group (P value ≤ 0.001). Furthermore, significant differences in the pain intensity between Iralvex and placebo group measured on days 1, 3, and 5 were obtained (P value ≤ 0.01). Conclusion. The results of this study show that Iralvex gel is effective and cheap remedy for treatment of RAS without side effects. This trial is registered with IRCT201207253251N3.

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Pengaruh suplementasi zink (Zn) terhadap diare pada penderita umur 6-36 bulan yang dirawat di RSUD Dr. Soedarso Pontianak, Kalimantan Barat

Jurnal Gizi Klinik Indonesia ◽

10.22146/ijcn.17427 ◽

2005 ◽

Vol 1 (3) ◽

pp. 113

Author(s):

Jurianto Gambir ◽

Madarina Julia ◽

Muhammad Jufrrie

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Zinc Supplementation ◽

Watery Diarrhea ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Double Blind ◽

Randomized Controlled ◽

Acute Watery Diarrhea ◽

Childhood Death

Background: Diarrhoea is one of the major causes of infants and childhood death in Indonesia. Malnutrition and zinc deficiency in diarrhoea may lead to impaired immunity.Objective: To assess the influence of zinc supplementation on the duration of diarrhoea and the frequency of watery stools in under-three-year-old childrenMethod: This was a double-blind randomized controlled clinical trial, with 31 children in the supplemented group and 33 children in the placebo group. All children had acute watery diarrhea and were given supplementation within 24 hours of admission. Daily supplementation of 20 mg zinc was given to the experimental group.Results: The supplemented group had a shorter hospitalization compared to the placebo. Beginning from the second day of supplementation, the frequency of watery stools in the supplemented group was significantly less than in the placebo group (p<0.001). While there was a significant decrease in the concentration of zinc in the serum of the placebo group, there was a slight increase in the supplemented group.Conclusion: Zinc supplementation can shorten hospitalization and reduce the frequency of watery stools in children with diarrhoea.

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