scholarly journals A homoeopathic drug proving of Carcharhinus leucas 30CH and a subsequent comparison with that of Galeocerdo cuvier hepar 30CH

2018 ◽  
Author(s):  
◽  
Nalini Naidoo
Keyword(s):  
Controlled Trial ◽  
Controlled Study ◽  
Double Blind ◽  
Materia Medica ◽  
Double Blind Placebo ◽  
Galeocerdo Cuvier ◽  
Carcharhinus Leucas ◽  
Before And After ◽  
History Of ◽  
The Mind

Introduction The aim of this study was to conduct a homoeopathic proving of Carcharhinus leucas in the thirtieth centesimal potency (30CH) and to subsequently establish and describe the symptomatology in standard materia medica format and then compare this symptomatology to Galeocerdo cuvier hepar 30CH. Methodology The homoeopathic proving of Carcharhinus leucas 30CH was conducted at the Durban University of Technology and was accomplished by means of a randomised, double blind, placebo controlled trial. Carcharhinus leucas 30CH was manufactured by the researchers according to Method 6, Method 8a and 10 of the German Homoeopathic Pharmacopoeia (Benyunes, 2005: 36-39). The homoeopathic proving was conducted in the form of a double blind placebo controlled study of Carcharhinus leucas 30CH with a total of 30 healthy provers. The prover sample was divided into two groups by a process of randomisation. Twenty four provers (80%) comprised the verum group and the remaining 6 provers (20%) comprised the placebo group. The identity of the proving substance and the potency used was not disclosed to provers. Provers documented their physical, mental and emotional status for one week preceding the administration of the proving remedy. A comprehensive physical examination and case history of every prover was taken before and after the proving period. Provers were instructed to ingest one powder three times a day for two days but were told to discontinue the powders once symptoms arose. The duration of the proving spanned 6 weeks and throughout the proving process, researchers were in constant communication with all the participants. Upon completion of the proving process, journals were collected and the information therein was translated into materia medica and repertory format. This was done in order to acquire the remedy picture of Carcharhinus leucas 30CH. Thereafter, the symptomatology of Carcharhinus leucas 30CH was compared to the symptomatology of Galeocerdo cuvier hepar 30CH. Results The proving of Carcharhinus leucas 30CH produced a total of 590 already existing rubrics and 43 new rubrics. The majority of these rubrics were located in the MIND (127), GENERALS (64), HEAD (55), EXTREMITIES (50), and EYE (34). In regard to the mind, prominent features were apparent such as anger, anxiety, cheerfulness, an aversion or amelioration within company, difficulty concentrating or increased focus, varying delusions and fears and irritability. Pertaining to the head, headaches were evident with varying concomitants and modalities, with headaches predominantly affecting the forehead and sides. Sensations included dryness, heat, heaviness, perspiration and shaking. The extremities displayed symptoms primarily in the forearms, legs and thighs and sensations included paralysis, shaking, swelling and weakness. In regard to the eye, eye pain with multiple modalities were apparent, with symptoms related to the canthi and eyelids. Sensations included heat, heaviness, inflammation, itching and photophobia as well as a visible discolouration of the eye. Analysis of the results presented an understanding of the similarities and differences between Carcharhinus leucas 30CH and Galeocerdo cuvier hepar 30CH. Conclusion As hypothesised, it was evident that administering Carcharhinus leucas 30CH to healthy individuals did yield observable symptomatology. Additionally, it was apparent that various correlations between Carcharhinus leucas 30CH and Galeocerdo cuvier hepar 30CH existed

scholarly journals Morinda citrifolia(Noni) as an Anti-Inflammatory Treatment in Women with Primary Dysmenorrhoea: A Randomised Double-Blind Placebo-Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
H. M. Fletcher ◽  
J. Dawkins ◽  
C. Rattray ◽  
G. Wharfe ◽  
M. Reid ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Morinda Citrifolia ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Menstrual Cycles ◽  
Primary Dysmenorrhoea ◽  
Before And After ◽  
Laboratory Variables ◽  
Anti Inflammatory ◽  
Bleeding Score

Introduction. Noni (Morinda citrifolia) has been used for many years as an anti-inflammatory agent. We tested the efficacy of Noni in women with dysmenorrhea.Method. We did a prospective randomized double-blind placebo-controlled trial in 100 university students of 18 years and older over three menstrual cycles. Patients were invited to participate and randomly assigned to receive 400 mg Noni capsules or placebo. They were assessed for baseline demographic variables such as age, parity, and BMI. They were also assessed before and after treatment, for pain, menstrual blood loss, and laboratory variables: ESR, hemoglobin, and packed cell volume.Results. Of the 1027 women screened, 100 eligible women were randomized. Of the women completing the study, 42 women were randomized to Noni and 38 to placebo. There were no significant differences in any of the variables at randomization. There were also no significant differences in mean bleeding score or pain score at randomization. Both bleeding and pain scores gradually improved in both groups as the women were observed over three menstrual cycles; however, the improvement was not significantly different in the Noni group when compared to the controls.Conclusion. Noni did not show a reduction in menstrual pain or bleeding when compared to placebo.

Oral Desensitization in Papular Urticaria in Children

2002 ◽  
Vol 32 (3) ◽  
pp. 142-145 ◽  
Author(s):  
Susana Giraldi ◽  
Ramón Ruiz-Maldonado ◽  
Lourdes Tamayo ◽  
Cristina Sosa-de-Martínez
Keyword(s):  
Vaccine Efficacy ◽  
Oral Vaccine ◽  
Effective Means ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Before And After ◽  
Insect Bites ◽  
Oral Desensitization

Papular urticaria (PU) is among the commonest skin ailments in children. Induced specific desensitization to insect bites is theoretically an effective means of prevention of PU. In this double blind placebo controlled study, an oral vaccine prepared from insect saliva was compared with placebo (stable vaccine solvent). Vaccine and placebo effectiveness were tested by counting active PU lesions, serum eosinophils, and IgE, before and after 4 months of treatment. Statistically significant differences between oral vaccine and placebo were not found in the clinical or the immunological variables tested. We conclude that, although a lack of oral vaccine efficacy was suspected, larger study samples are needed to strengthen our conclusion.

scholarly journals Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study

Gut ◽  
2018 ◽  
Vol 67 (12) ◽  
pp. 2107-2115 ◽  
Author(s):  
Sofie Ingdam Halkjær ◽  
Alice Højer Christensen ◽  
Bobby Zhao Sheng Lo ◽  
Patrick Denis Browne ◽  
Stig Günther ◽  
...  
Keyword(s):  
Gut Microbiota ◽  
Controlled Trial ◽  
Symptom Relief ◽  
Controlled Study ◽  
Faecal Microbiota ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Faecal Microbiota Transplantation ◽  
Faecal Samples ◽  
Significant Difference

ObjectiveIBS is associated with an intestinal dysbiosis and faecal microbiota transplantation (FMT) has been hypothesised to have a positive effect in patients with IBS. We performed a randomised, double-blind placebo-controlled trial to investigate if FMT resulted in an altered gut microbiota and improvement in clinical outcome in patients with IBS.DesignWe performed this study in 52 adult patients with moderate-to-severe IBS. At the screening visit, clinical history and symptoms were assessed and faecal samples were collected. Patients were randomised to FMT or placebo capsules for 12 days and followed for 6 months. Study visits were performed at baseline, 1, 3 and 6 months, where patients were asked to register their symptoms using the IBS-severity scoring system (IBS-SSS) and IBS-specific quality of life (IBS-QoL). Prior to each visit, faecal samples were collected.ResultsA significant difference in improvement in IBS-SSS score was observed 3 months after treatment (p=0.012) favouring placebo. This was similar for IBS-QoL data after 3 months (p=0.003) favouring placebo. Patients receiving FMT capsules had an increase in faecal microbial biodiversity while placebos did not.ConclusionIn this randomised double-blinded placebo-controlled study, we found that FMT changed gut microbiota in patients with IBS. But patients in the placebo group experienced greater symptom relief compared with the FMT group after 3 months. Altering the gut microbiota is not enough to obtain clinical improvement in IBS. However, different study designs and larger studies are required to examine the role of FMT in IBS.Trial registration numberNCT02788071.

scholarly journals Oral Intake of Hydrangea serrata (Thunb.) Ser. Leaves Extract Improves Wrinkles, Hydration, Elasticity, Texture, and Roughness in Human Skin: A Randomized, Double-Blind, Placebo-Controlled Study

Nutrients ◽  
2020 ◽  
Vol 12 (6) ◽  
pp. 1588
Author(s):  
Da-Bin Myung ◽  
Jeong-Hun Lee ◽  
Hee-Soo Han ◽  
Kwang-Young Lee ◽  
Hye Shin Ahn ◽  
...  
Keyword(s):  
Human Skin ◽  
Elastic Recovery ◽  
Controlled Trial ◽  
Water Extract ◽  
Hot Water ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Skin Wrinkles

Previously, we reported that the hot water extract of Hydrangea serrata leaves (WHS) and its active component, hydrangenol, possess in vitro and in vivo effects on skin wrinkles and moisturization. We conducted a randomized, double-blind, placebo-controlled trial to clinically evaluate the effect of WHS on human skin. Participants (n = 151) were randomly assigned to receive either WHS 300 mg, WHS 600 mg, or placebo, once daily for 12 weeks. Skin wrinkle, hydration, elasticity, texture, and roughness parameters were assessed at baseline and after 4, 8, and 12 weeks. Compared to the placebo, skin wrinkles were significantly reduced in both WHS groups after 8 and 12 weeks. In both WHS groups, five parameters (R1–R5) of skin wrinkles significantly improved and skin hydration was significantly enhanced when compared to the placebo group after 12 weeks. Compared with the placebo, three parameters of skin elasticity, including overall elasticity (R2), net elasticity (R5), and ratio of elastic recovery to total deformation (R7), improved after 12 weeks of oral WHS (600 mg) administration. Changes in skin texture and roughness were significantly reduced in both WHS groups. No WHS-related adverse reactions were reported. Hence, WHS could be used as a health supplement for skin anti-aging.

Studies of Carbamazepine Extended-Release Capsules in Bipolar Disorder

CNS Spectrums ◽  
2005 ◽  
Vol 10 (6) ◽  
pp. 3-5
Author(s):  
Richard H. Weisler
Keyword(s):  
Extended Release ◽  
Rating Scale ◽  
Controlled Trial ◽  
Controlled Study ◽  
Mixed States ◽  
Open Label ◽  
Young Mania ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Bipolar Patients

This discussion reviews data from two 3-week, double-blind, placebo-controlled pivotal trials of carbamazepine extended release capsules (CBZ ERC; SPD417.301 and SPD417.304); pooled results from these trials; data from a 3-week, double-blind, placebo-controlled trial in lithium non-responders or non-tolerators (SPD417.302); and additional supportive data from a 6-month, open-label, extension trial (SPD417.303). In addition, information on a retrospective chart review of 600 adolescent and adult bipolar patients on CBZ ERC is presented.In the first large double-blind, placebo-controlled study assessing CBZ ERC in acute mania, manic and mixed bipolar patients from multiple centers were hospitalized and all medications were discontinued. After reaching a stable baseline 2–5 days later, the patients were randomized to CBZ ERC (n=101; 59% with mixed states) or placebo (n=103; 47% with mixed states) for 3 weeks. An aggressive initial titration schedule was implemented, beginning with 200 mg BID and increased by 200 mg/day until good clinical response was achieved or the patient could not tolerate the dosage. Many patients were taking 1,200–1,600 mg/day by the end of week 1. Efficacy was assessed using the Young Mania Rating Scale (YMRS). The Clinical Global Impressions (CGI) scale and the Hamilton Rating Scale for Depression (HAM-D) were also followed.

Studies of Carbamazepine Extended-Release Capsules in Bipolar Disorder

CNS Spectrums ◽  
2005 ◽  
Vol 10 (S1) ◽  
pp. 3-5
Author(s):  
Richard H. Weisler
Keyword(s):  
Extended Release ◽  
Rating Scale ◽  
Controlled Trial ◽  
Controlled Study ◽  
Mixed States ◽  
Open Label ◽  
Young Mania ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Bipolar Patients

This discussion reviews data from two 3-week, double-blind, placebo-controlled pivotal trials of carbamazepine extended release capsules (CBZ ERC; SPD417.301 and SPD417.304); pooled results from these trials; data from a 3-week, double-blind, placebo-controlled trial in lithium non-responders or non-tolerators (SPD417.302); and additional supportive data from a 6-month, open-label, extension trial (SPD417.303). In addition, information on a retrospective chart review of 600 adolescent and adult bipolar patients on CBZ ERC is presented.In the first large double-blind, placebo-controlled study assessing CBZ ERC in acute mania, manic and mixed bipolar patients from multiple centers were hospitalized and all medications were discontinued. After reaching a stable baseline 2–5 days later, the patients were randomized to CBZ ERC (n=101; 59% with mixed states) or placebo (n=103; 47% with mixed states) for 3 weeks. An aggressive initial titration schedule was implemented, beginning with 200 mg BID and increased by 200 mg/day until good clinical response was achieved or the patient could not tolerate the dosage. Many patients were taking 1,200–1,600 mg/day by the end of week 1. Efficacy was assessed using the Young Mania Rating Scale (YMRS). The Clinical Global Impressions (CGI) scale and the Hamilton Rating Scale for Depression (HAM-D) were also followed.

scholarly journals Efficacy and Safety of Yokukansan in Treatment-Resistant Schizophrenia: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-11 ◽  
Author(s):  
Tsuyoshi Miyaoka ◽  
Motohide Furuya ◽  
Jun Horiguchi ◽  
Rei Wake ◽  
Sadayuki Hashioka ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Treatment Resistant ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Intention To Treat ◽  
The Difference ◽  
The Individual

Objectives. We aimed at evaluating both the efficacy and safety of TJ-54 (Yokukansan) in patients with treatment-resistant schizophrenia. This randomized, multicenter, double-blind, placebo-controlled study was conducted.Methods. One hundred and twenty antipsychotic-treated inpatients were included. Patients were randomized to adjuvant treatment with TJ-54 or placebo. During a 4-week follow-up, psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS).Results. TJ-54 showed a tendency of being superior to placebo in reduction total, positive, and general PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant in both per-protocol set (PPS) and intention-to-treat (ITT). However, in PPS analysis, compared to the placebo group, the TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores for lack of spontaneity and flow of conversation (TJ-54:−0.23±0.08; placebo:−0.03±0.08,P<0.018), tension (TJ-54:−0.42±0.09; placebo:−0.18±0.09,P<0.045), and poor impulse control (TJ-54:−0.39±0.10; placebo:−0.07±0.10,P<0.037).Conclusions. The results of the present study indicate that TJ-54 showed a tendency of being superior to placebo in reduction PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant. However, compared to the placebo group, TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores.

scholarly journals Effects of Bushen-Jiangya granules on blood pressure and pharmacogenomic evaluation in low-to-medium risk hypertension: study protocol for a randomized double-blind controlled trial

2021 ◽  
Author(s):  
xiaochen Yang ◽  
Xingjiang Xiong ◽  
Yun Zhang ◽  
Yongmei Liu ◽  
Hongzheng Li ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Inflammatory Responses ◽  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Medium Risk ◽  
Tcm Syndrome ◽  
And Control

Abstract IntroductionHypertension is one of the most important risk factors for cardiovascular disease, and its treatment and control rates are still low worldwide. The most effective strategy is that patients with hypertension should be diagnosed and treated early. Preliminary studies showed that the Bushen Jiangya granule (BSJY) may suppress ventricular hypertrophy and inflammatory responses, lower blood pressure and protect the target organs of hypertension. We designed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of BSJY in patients with low-to-medium risk hypertension.Methods and analysisThis trial is a one-center, randomized, double-blind, placebo-controlled study. A total of 260 participants will be randomized in a 1:1 ratio to an experiment group (BSJY plus amlodipine) and a control group (placebo plus amlodipine). The trial cycle will last 8 weeks. The primary outcome is blood pressure, which is reduced to a threshold set out in Guiding Principles for Clinical Research of New Chinese Medicines. The secondary outcomes include the change in 24-h average systolic and diastolic blood pressure, heart rate variability, pharmacogenomic Evaluation, improvement in TCM Syndrome, serum pro-inflammatory/anti-inflammatory cytokines, etc. between the two groups. Safety in medication will also be evaluated. All the data will be recorded in electronic case report forms and analyzed by SPSS V.22.0.Ethics and dissemination This study has been approved by Research Ethics Committee of Guang’anmen Hospital,China Academy of Chinese Medical Sciences in Beijing, China (No. 2019-186-KY-01). The participants are volunteers, understand the process of this trial and sign an informed consent. The results of this study will be disseminated to the public through peer-reviewed journals and academic conferences. DiscussionWe hypothesize that patients with low-to-medium risk hypertension will benefit from BSJY. If successful, this study will provide evidence-based recommendations for clinicians.

Nasal Immunotherapy is Effective in the Treatment of Rhinitis Due to Mite Allergy. A Double Blind Placebo-Controlled Study with Rhinological Evaluations

2002 ◽  
Vol 15 (2) ◽  
pp. 141-147 ◽  
Author(s):  
D. Passàli ◽  
L. Bellussi ◽  
G.C. Passàli ◽  
F. M. Passàli
Keyword(s):  
Allergic Rhinitis ◽  
Mucociliary Clearance ◽  
Controlled Trial ◽  
Controlled Study ◽  
Perennial Allergic Rhinitis ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Nasal Provocation ◽  
Mite Allergy ◽  
Perennial Rhinitis

The aim of this paper is to evaluate the efficacy of intranasal hyposensitizing therapy in perennial rhinitis. 36 patients suffering from perennial allergic rhinitis (Dermatophagoides-sensitive) underwent a double blind placebo-controlled trial for a period of 8 months. The efficacy of nasal immunotherapy was evaluated by collecting symptoms score and evaluating objective rhinological parameters (nasal resistance, cross areas and volumes, mucociliary clearance times, specific nasal provocation threshold). A significant improvement (p0,01) of symptom score of active against placebo group was observed after treatment. Also objective nasal parameters (total nasal resistances, mucociliary clearance, C-notch area, and provocative threshold) significantly (p0,01) improved after treatment. Adverse local reactions were rare and did not interfere with the protocol. The results underline the efficacy and quickness of local nasal immunotherapy in the treatment of perennial allergic rhinitis documented by the improvement of subjective and objective parameters.

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