scholarly journals Efficacy and safety of tetramethylpyrazine phosphate on pulmonary hypertension: study protocol for a randomized controlled study

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Yuqin Chen ◽  
Wenjun He ◽  
Haiping Ouyang ◽  
Chunli Liu ◽  
Cheng Hong ◽  
...  
Keyword(s):  
Pulmonary Hypertension ◽  
Treatment Group ◽  
Phase Iii ◽  
World Health ◽  
Controlled Study ◽  
Stable Phase ◽  
Control Group ◽  
Efficacy And Safety ◽  
Traditional Chinese Herbal Medicine ◽  
Health Organization

Abstract Background Tetramethylpyrazine (TMP), an active ingredient in the traditional Chinese herbal medicine Rhizoma Chuanxiong, has been used clinically for the prevention and treatment of cardiovascular disease. The benefits of TMP are largely attributed to its anti-oxidative and vasodilative properties. However, the efficacy of TMP in the treatment of pulmonary hypertension (PH) is unknown. We hypothesized that TMP may have a therapeutic effect in patients with PH. Methods/design A randomized, single-blinded, clinical study with a TMP treatment group and a control group will be conducted to evaluate the efficacy and safety of TMP intervention in patients with PH. The recruitment target is 120 subjects meeting the following criteria: (i) at rest and at sea level, mean pulmonary artery pressure above 20 mmHg and pulmonary capillary wedge pressure below 15 mmHg; (ii) type 1 or 4 PH in the stable phase; (iii) age 15–70 years; (iv) 6-min walk distance between 100 and 450 m; (v) World Health Organization (WHO) functional classification of pulmonary hypertension of II, III, or IV. Subjects will be assigned randomly into two groups at a ratio of 1:2 (control:TMP). Both groups will receive routine treatment, and the treatment group will also receive oral TMP (100 mg) three times a day for 16 weeks. All patients will be followed up for 4, 8, 12, and 16 weeks; symptoms and patient compliance will be recorded. Discussion We aimed to determine the efficacy and safety of TMP for the treatment of PH. Trial registration Chinese Clinical Trial Register, ChiCTR1800018664. Registered on 2 October 2018.

scholarly journals Efficacy and safety of Tetramethylpyrazine (TMP) Phosphate on Pulmonary Hypertension: study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Jian Wang ◽  
Yuqin Chen ◽  
Wenjun He ◽  
Haiping Ouyang ◽  
Chunli Liu ◽  
...  
Keyword(s):  
Pulmonary Hypertension ◽  
Treatment Group ◽  
Controlled Trial ◽  
Phase Iii ◽  
Stable Phase ◽  
Control Group ◽  
Efficacy And Safety ◽  
Traditional Chinese Herbal Medicine ◽  
Level Ii ◽  
Pulmonary Capillary

Abstract Background: Tetramethylpyrazine (TMP), an active ingredient in the traditional Chinese herbal medicine Rhizoma Chuanxiong, has been used clinically for the prevention and treatment of cardiovascular disease. The benefits of TMP are largely attributed to its anti-oxidative and vasodilative properties. However, the efficacy of TMP in the treatment of pulmonary hypertension (PH) is unknown. We hypothesized that TMP may have a therapeutic effect in patients with PH.Methods:A randomized, single-blinded, clinical study with a TMP treatment group and a control group will be conducted to evaluate the efficacy and safety of TMP intervention in patients with PH. The recruitment target is 120 subjects meeting the following criteria: (i) At rest and at sea level, mean pulmonary artery pressure above 20 mmHg and pulmonary capillary wedge pressure below 15 mmHg; (ii) Type 1 or 4 PH in the stable phase; (iii) age 15–70 years; (iv) 6-minute walk distance between 100 and 450 meters; (v) lung function at level II, III, or IV according to WHO classification. Subjects will be assigned randomly into two groups at a ratio of 1:2 (control:TMP). Both groups will receive routine treatment, and the treatment group will also receive oral TMP (100 mg) three times a day for 16 weeks. All patients will be followed up for 4, 8, 12, and 16 weeks, and symptoms and patient compliance will be recorded.Discussion:We aim to determine the efficacy and safety of TMP for the treatment of PH.Study registration:ChiCTR1800018664, http://www.chictr.org.cn/edit.aspx?pid=31565&htm=4 (registered on 2 October 2018).

scholarly journals Efficacy and Safety of Maxing Xianchang Su in the Treatment of Functional Constipation: A Randomized Controlled Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Mi Li ◽  
Lijuan Zhao ◽  
Li Ma ◽  
Wen Zhang ◽  
Hua Huang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Controlled Trial ◽  
Functional Constipation ◽  
Oral Solution ◽  
Controlled Study ◽  
Symptom Improvement ◽  
Control Group ◽  
Efficacy And Safety ◽  
Randomized Controlled

Background. Functional constipation (FC) is one of the prevalent gastrointestinal disorders that affect people of all ages. Long-term FC has significant effects on the quality of life of patients. Although commonly used drugs have reliable short-term effects, they are easily addictive and have side effects. Therefore, pursuing a convenient drug-food homogenous program is critical for FC patients. Maxing Xianchang Su is a functional food based on traditional Chinese medicine. To investigate the efficacy and safety of Maxing Xianchang Su in FC treatment, we conducted a randomized controlled trial. Methods. We carried out a prospective multicenter randomized parallel controlled study in three hospitals in Jiangsu Province, China, from January 2020 to March 2021, which included 206 FC patients. All patients were arbitrarily assigned into a treatment group and a control group at a ratio of 1 : 1; 103 cases in each group. The treatment group was given oral Maxing Xianchang Su, whereas the control group was treated with lactulose oral solution. The course of treatment was two weeks. The two groups of patients were evaluated after six weeks for symptom improvement before and after taking the drug. Furthermore, the safety of Maxing Xianchang Su was assessed. Results. Both groups of patients successfully completed the study without shedding cases. The effective rates of the treatment group and control group after two weeks were 90.6% and 67.0%, respectively. The treatment group had a better curative effect than the control group ( P < 0.05 ). The symptom score of the two groups improved compared with that before the treatment. The difference between the two groups was statistically significant ( P < 0.05 ). During the treatment process, neither group experienced abnormal changes in blood lipid, blood glucose, routine hematuria, or liver and kidney functions. There were no adverse reactions in both groups. Conclusion. Maxing Xianchang Su has a positive effect on FC treatment with reliable mid-term effect and a high level of safety.

Psychoeducation Group on Improving Quality of Life of Mild Cognitive Impaired Elderly

2017 ◽  
Vol 29 (3) ◽  
pp. 303-310 ◽  
Author(s):  
Daniel Kim-wan Young ◽  
Petrus Yat-nam Ng ◽  
Daphne Cheng
Keyword(s):  
Quality Of Life ◽  
Treatment Group ◽  
Controlled Trial ◽  
T Test ◽  
World Health ◽  
Control Group ◽  
World Health Organization Quality ◽  
Life Measure ◽  
Health Organization

Purpose: This research study aims to evaluate the effectiveness of a psychoeducation group, which is founded on an Eastern approach to health care, in improving the quality of life of Chinese people with mild cognitive impairment (PwMCI). Method: In a randomized controlled trial (RCT), 40 Chinese PwMCI were randomly assigned to either a 10-session psychoeducation group or the control group. Results: A paired sample t test indicated that the treatment group ( n = 18) showed significant improvement in their World Health Organization Quality of Life Measure (WHOQOL) score, while the control group ( n = 22) did not. Moreover, an independent t test showed that the treatment group was more effective than the control group to improve their WHOQOL score. A reduction in the depressive symptoms was related to the improvement in WHOQOL score. Conclusions: This RCT provides evidence to support the feasibility and effectiveness of psychoeducation groups for improving the overall quality of life of PwMCI.

scholarly journals Efficacy and safety of tetramethylpyrazine phosphate on pulmonary hypertension: study protocol for a randomized controlled study

2019 ◽  
Author(s):  
Jian Wang ◽  
Yuqin Chen ◽  
Wenjun He ◽  
Haiping Ouyang ◽  
Chunli Liu ◽  
...  
Keyword(s):  
Pulmonary Hypertension ◽  
Cardiovascular Diseases ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Traditional Chinese Herbal Medicine ◽  
Rhizoma Chuanxiong ◽  
Randomized Controlled ◽  
Chinese Herbal ◽  
Prevention And Treatment ◽  
Tetramethylpyrazine Phosphate

Abstract Introduction Tetramethylpyrazine (TMP), one of the active ingredients from the traditional Chinese herbal medicine Rhizoma Chuanxiong (Chuanxiong), has been clinically used for the prevention and treatment on cardiovascular diseases. The benefits of TMP are largely attributed to its anti-oxidize and vasodilative activities. However, the efficacy of TMP in the treatment of pulmonary hypertension(PH) is unknown, in this study, we hypothesized that TMP treatment has a therapeutic effect on PH patients.

scholarly journals A study to evaluate the impact of a 21-day school brushing intervention on the knowledge, behaviour and oral health of schoolchildren (Preprint)

2019 ◽  
Author(s):  
Paulo Melo ◽  
Sinead Malone ◽  
Arathi Rao ◽  
Charlotte Fine
Keyword(s):  
Oral Health ◽  
Oral Care ◽  
Cluster Randomized Trial ◽  
Day School ◽  
Phase Iii ◽  
World Health ◽  
Control Group ◽  
Fluoride Toothpaste ◽  
Health Organization ◽  
The Impact

BACKGROUND The World Health Organization reports that dental cavities affect 60-90% of children globally. FDI World Dental Federation and Unilever Oral Care have developed public health programmes to improve brushing habits over their 12-year partnership. The last of these (Phase III) named Brush Day & Night aimed to educate children in brushing twice daily with a fluoride toothpaste. OBJECTIVE In Phase IV of the partnership, we aim to evaluate the impact on the knowledge, behaviour and toothbrushing habits in schoolchildren aged 6-9 years old, after a 21-day school programme and compare with baseline and a control group. The enduring nature of the programme will be determined by the inclusion of 8 and 24-week time points. METHODS The study is a two-arm, parallel, stratified, cluster randomized trial. Clusters in this study are infant and junior schools in Indonesia and Nigeria. The study aims to recruit 20 schools in each country. At baseline, children in both intervention and control schools will complete questionnaires and have their oral health assessed via the Simplified Oral Hygiene Index (OHIs) and Decayed Missing and Filled Teeth (DMFT). Children in the intervention schools will then take part in a structured 21-day Brush Day & Night intervention. The Brush Day & Night programme is an intense education activity designed to establish the habit of brushing day and night with a fluoride toothpaste. The programme involves daily brushing instruction and includes free toothpaste and toothbrushes. Children in the control schools will be provided with free toothpaste and toothbrushes but will not receive the 21-day intervention. The questionnaires and OHIs assessment are repeated after 21 days and then again at 8 weeks and 24 weeks later for all participating children. Parents/Carers/Guardians of all children will complete questionnaires on their own experience and attitudes to oral health and toothbrushing routine at each of the four times points (baseline, 21-day, 8 weeks and 24 weeks). The study will be conducted by the National Dental Associations of Indonesia and Nigeria. RESULTS The study is ongoing. Recruitment of schools started in Indonesia in February 2018 and in Nigeria in April 2018 for the first part of the study. This concluded in Indonesia in September 2018 and in Nigeria in November 2018. The second part of the study (the second half of the schools) started in November 2018 in Indonesia and December 2018 in Nigeria. CONCLUSIONS We expect to publish findings from the study by March 2020.

IL-10-592 A/C Gene Polymorphism and Cytokine Levels are Associated with Susceptibility to Drug Resistance in Tuberculosis

2020 ◽  
Vol 8 (3) ◽  
pp. 103-112
Author(s):  
Atefeh SADEGHI SHERMEH ◽  
Majid KHOSHMIRSAFA ◽  
Ali-Akbar DELBANDI ◽  
Payam TABARSI ◽  
Esmaeil MORTAZ ◽  
...  
Keyword(s):  
Serum Levels ◽  
World Health ◽  
Control Group ◽  
Drug Resistant ◽  
Nucleotide Polymorphisms ◽  
Genotype Frequencies ◽  
Cytokine Levels ◽  
Ifn Γ ◽  
Health Organization ◽  
And Function

Introduction: Tuberculosis (TB) and especially resistant forms of it have a substantial economic burden on the community health system for diagnosis and treatment each year. Thus, investigation of this field is a priority for the world health organization (WHO). Cytokines play important roles in the relationship between the immune system and tuberculosis. Genetic variations especially single nucleotide polymorphisms (SNPs) impact cytokine levels and function against TB. Material and Methods: In this research SNPs in IFN-γ (+874 T/A) and IL-10 (-592 A/C) genes, and the effects of these SNPs on cytokine levels in a total of 87 tuberculosis patients and 100 healthy controls (HCs) were studied. TB patients divided into two groups: 1) 67 drug-sensitive (DS-TB) and 2) 20 drug-resistant (DR-TB) according to drug sensitivity test using polymerase chain reaction (PCR). For the genotyping of two SNPs, the PCR-based method was used and IFN-γ and IL-10 levels were measured by ELISA in pulmonary tuberculosis (PTB) and control group. Results: In -592A/C SNP, only two genotypes (AA, AC) were observed and both genotypes showed statistically significant differences between DR-TB and HCs (p=0.011). IL-10 serum levels in PTB patients were higher than HCs (p=0.02). The serum levels of IFN-γ were significantly higher in DS-TB patients than that of the other two groups (p<0.001); however, no significant differences were observed for allele and genotype frequencies in IFN-γ +874. Conclusions: Our results suggest that the SNP at -592 position of IL-10 gene may be associated with the susceptibility to DR-TB. However, further investigation is necessary. Keywords: Polymorphism, IFN-γ, IL-10, tuberculosis, drug-resistant tuberculosis

Hypoxic Pulmonary Vasoconstriction and Chronic Lung Disease

2013 ◽  
Vol 12 (3) ◽  
pp. 135-144 ◽  
Author(s):  
Erik R. Swenson
Keyword(s):  
Pulmonary Hypertension ◽  
Lung Disease ◽  
Hypoxic Pulmonary Vasoconstriction ◽  
World Health ◽  
Disease States ◽  
Pulmonary Vasoconstriction ◽  
Local Ventilation ◽  
Pulmonary Vascular Endothelium ◽  
Health And Disease ◽  
Health Organization

Hypoxic vasoconstriction in the lung is a unique and fundamental characteristic of the pulmonary circulation. It functions in health and disease states to better preserve ventilation-perfusion matching by diverting blood flow to better ventilated regions when local ventilation is compromised. As more areas of lung become hypoxic either with high altitude or global lung disease, then hypoxic pulmonary vasoconstriction (HPV) becomes less effective in ventilation-perfusion matching and can lead to pulmonary hypertension. HPV is intrinsic to the vascular smooth muscle and its mechanisms remain poorly understood. In addition, the pulmonary vascular endothelium, red cells, lung innervation, and numerous circulating vasoactive agents also affect the strength of HPV. This review will discuss the pathophysiology of HPV and address its role in pulmonary hypertension associated with World Health Organization Group 3 diseases. When sustained beyond many hours, HPV may initiate pulmonary vascular remodeling and lead to more fixed and less oxygen-responsive pulmonary hypertension if the hypoxic stimulus is maintained.

Clinical Study of Qingpeng Ointment Treatment of Shoulder-Hand Syndrome After Cerebral Hemorrhage During the Rehabilitation Period

2020 ◽  
Vol 23 ◽  
Author(s):  
Ruihuan Pan ◽  
Shanshan Ling ◽  
Haodong Yang ◽  
Yan Huang ◽  
Lechang Zhan ◽  
...  
Keyword(s):  
Treatment Group ◽  
Cerebral Hemorrhage ◽  
Clinical Medicine ◽  
External Rotation ◽  
Statistical Significance ◽  
Hand Function ◽  
Tibetan Medicine ◽  
Controlled Study ◽  
Control Group ◽  
The Difference

Background: Shoulder-hand syndrome (SHS) refers to a syndrome causing sudden edema, shoulder pain and limited hand function. Qingpeng ointment, a kind of Tibetan medicine, can reduce swelling, relieve pain, tonify stagnation and clear the meridians, which is consistent with the pathological mechanism of SHS after stroke. Therefore, if clinical trials can be used to explore the effectiveness of Qingpeng ointment for treatment of poststroke SHS and promote its application in clinical medicine, this is of specific significance for the treatment of poststroke SHS. Objective: To investigate the clinical efficacy and safety of Qingpeng ointment in the treatment of poststroke SHS. To provide an objective basis for a better therapeutic treatment for poststroke SHS． Method: A prospective, randomized, controlled study was conducted. This study recruited 120 patients with poststroke SHS who met the inclusion criteria. They were randomized into the treatment group and the control group, with 60 patients allocated to each group. The treatment group received routine medical treatment and rehabilitative care after using the Qingpeng ointment, while the patients in the control group received only routine treatment without the ointment. All patients received clinical assessment with the Visual Analogue Scale (VAS), measurement of the range of motion (ROM) of the upper-limb joints, the Fugl-Meyer Assessment of Upper Extremity (FMA-U) and the Modified Barthel Index Score (MBI) before and after the whole treatment. Results: After 4 weeks of treatment, the VAS scores of both groups were decreased significantly (P＜0.05), and the difference between the two groups was statistically significant (P < 0.05). There is no statistical significance for the difference between the treatment group and control group in terms of the FMA-U and MBI scores and the forward bend, backward, outstretch, external rotation and pronation angles after treatment. The increases in the values of VAS, FMA-M and MBI in the treatment group were greater than those in the control group, and the difference was statistically significant (P < 0.05). The increases in the values of the forward bend, outreach and external rotation angles in the treatment group were greater than those in the control group, and the difference was statistically significant (P < 0.05). Conclusion: The treatment group showed better results than the control group in terms of the relief of pain symptoms, the improvement of motor function and the improvement of the activities of daily living for patients with shoulder-hand syndrome after cerebral hemorrhage. Qingpeng ointment is effective and safe in treating poststroke SHS.

scholarly journals Quality of life in patients with narcolepsy: a WHOQOL-bref study

2008 ◽  
Vol 66 (2a) ◽  
pp. 163-167 ◽  
Author(s):  
Heloísa Rovere ◽  
Sueli Rossini ◽  
Rubens Reimão
Keyword(s):  
Quality Of Life ◽  
Patient Group ◽  
World Health ◽  
Control Group ◽  
World Health Organization Quality ◽  
Severe Impairment ◽  
Perception Of Quality ◽  
Social Domains ◽  
Health Organization

OBJECTIVE: To evaluate the perception of Quality of Life (QL) in Brazilian patients with narcolepsy. METHOD: 40 adult patients aged between 20 and 72 years (mean=41.55; SD=14.50); (28 F; 12M), with the diagnosis of chronic narcolepsy were followed up at the outpatient clinic (Patient Group). The Control Group was composed of 40 adults. The instrument utilized was the World Health Organization Quality of Life (WHOQOL-BREF). RESULTS: The two groups were homogeneous and no difference was found with regards to age, sex, and demographic characteristics. The perception of QL in physical, psychological and social domains showed lower scores in those patients with narcolepsy than in the control group (p<0.05). Concerning physical domain, all the aspects evaluated were significantly impaired, in patient group, including sleep satisfaction (p<0.001); energy for daily activities (p=0.039); capacity to perform activities (p=0.001); and capacity to work (p=0.001). CONCLUSION: The perception of QL showed severe impairment in patients with narcolepsy for physical, psychological and social domains.

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