scholarly journals Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial

2020 ◽  
Author(s):  
Congcong Zeng ◽  
Xi Liu ◽  
Lufeng Hu ◽  
Yuan Feng ◽  
Nengzhi Xia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Outcome Measures ◽  
Study Protocol ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Resonance Spectroscopy ◽  
Double Blind ◽  
Drug Intervention ◽  
Double Blind Placebo ◽  
Insomnia Symptoms

Abstract Background: Insomnia seriously affects people’s normal lives and work. However, effective treatment strategies are scarce. The purpose of this study is to explore the efficacy and safety of Jiao-tai-wan (JTW) for ameliorating insomnia symptoms caused by disharmony of the heart and kidney. Design: This is a randomized, double-blind, placebo-controlled pilot clinical trial. One hundred twenty-four participants suffering from insomnia symptoms will randomly assigned to the JTW or placebo group in an equal ratio. The participants will be asked to take JTW or placebo granules twice a day for 1 week. All data will be gathered at baseline and at the end of drug intervention. The primary outcome measures will be the mean change in the Pittsburgh sleep quality index (PSQI) from baseline to the end of drug intervention. Secondary outcome measures will include the the altered sleep parameters in polysomnography, 1H-magnetic resonance spectroscopy (1H-MRS) evalution, the Disharmony of Heart and Kidney Scoring System score and blood tests, including the levels of serum adenosine and melatonin. A laboratory test will be taken before and after treatment to assess the safety of JTW. Discussion: The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms, and will also be used to monitor the safety of JTW. Trial registration: Chinese Clinical Trial Registry, ChiCTR1800019239.Registered on 1st November 2018- Retrospectively registered, http://www.chictr.org.cn/. Keywords: Jiao-tai-wan, Insomnia, Traditional herbal medicine, Randomized controlled trial, Study protocol, Pattern identification Protocol version: Manuscript based on study protocol version 1.3, 1 November 2018.

scholarly journals Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial

2019 ◽  
Author(s):  
Congcong Zeng ◽  
Xi Liu ◽  
Lufeng Hu ◽  
Yuan Feng ◽  
Nengzhi Xia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Outcome Measures ◽  
Study Protocol ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Resonance Spectroscopy ◽  
Double Blind ◽  
Drug Intervention ◽  
Double Blind Placebo ◽  
Insomnia Symptoms

Abstract Background: Insomnia seriously affects people’s normal lives and work. However, effective treatment strategies are scarce. The purpose of this study is to explore the efficacy and safety of Jiao-tai-wan (JTW) for ameliorating insomnia symptoms caused by disharmony of the heart and kidney. Design: This is a randomized, double-blind, placebo-controlled pilot clinical trial. One hundred twenty-eight participants suffering from insomnia symptoms will randomly assigned to the JTW or placebo group in an equal ratio. The participants will be asked to take JTW or placebo granules twice a day for 1 week. All data will be gathered at baseline and at the end of drug intervention. The primary outcome measures will be the mean change in the Pittsburgh sleep quality index (PSQI) from baseline to the end of drug intervention. Secondary outcome measures will include the the altered sleep parameters in polysomnography, 1H-magnetic resonance spectroscopy (1H-MRS) evalution, the Disharmony of Heart and Kidney Scoring System score and blood tests, including the levels of serum adenosine and melatonin. A laboratory test will be taken before and after treatment to assess the safety of JTW. Discussion: The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms, and will also be used to monitor the safety of JTW. Trial registration: Chinese Clinical Trial Registry, ChiCTR1800019239.Registered on 1st November 2018- Retrospectively registered, http://www.chictr.org.cn/. Keywords: Jiao-tai-wan, Insomnia, Traditional herbal medicine, Randomized controlled trial, Study protocol, Pattern identification

scholarly journals Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Congcong Zeng ◽  
Xi Liu ◽  
Lufeng Hu ◽  
Yuan Feng ◽  
Nengzhi Xia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Resonance Spectroscopy ◽  
Double Blind ◽  
Drug Intervention ◽  
Double Blind Placebo ◽  
Link Type ◽  
Insomnia Symptoms

Abstract Background Insomnia seriously affects people’s normal lives and work. However, effective treatment strategies are scarce. The purpose of this study is to explore the efficacy and safety of Jiao-tai-wan (JTW) for ameliorating insomnia symptoms caused by disharmony of the heart and kidney. Design This is a randomized, double-blind, placebo-controlled pilot clinical trial. A total of 124 participants suffering from insomnia symptoms will be randomly assigned to the JTW or placebo group in an equal ratio. The participants will be asked to take JTW or placebo granules twice a day for 1 week. All data will be gathered at baseline and at the end of the drug intervention. The primary outcome measures will be the mean change in the Pittsburgh Sleep Quality Index (PSQI) from baseline to the end of the drug intervention. Secondary outcome measures will include the altered sleep parameters in polysomnography, 1H-magnetic resonance spectroscopy (1H-MRS) evaluation, the Disharmony of Heart and Kidney Scoring System score, and blood tests, including the levels of serum adenosine and melatonin. A laboratory test will be taken before and after treatment to assess the safety of JTW. Discussion The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms and will also be used to monitor the safety of JTW. Trial registration Chinese Clinical Trial Registry, ChiCTR1800019239. Registered on 1st November 2018.

scholarly journals Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial

2020 ◽  
Author(s):  
Congcong Zeng ◽  
Xi Liu ◽  
Lufeng Hu ◽  
Yuan Feng ◽  
Nengzhi Xia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Resonance Spectroscopy ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Drug Intervention ◽  
Double Blind Placebo ◽  
Insomnia Symptoms

Abstract Background: Insomnia seriously affects people’s normal lives and work. However, effective treatment strategies are scarce. The purpose of this study is to explore the efficacy and safety of Jiao-tai-wan (JTW) for ameliorating insomnia symptoms caused by disharmony of the heart and kidney. Design: This is a randomized, double-blind, placebo-controlled pilot clinical trial. One hundred twenty- four participants suffering from insomnia symptoms will randomly assigned to the JTW or placebo group in an equal ratio. The participants will be asked to take JTW or placebo granules twice a day for 1 week. All data will be gathered at baseline and at the end of drug intervention. The primary outcome measures will be the mean change in the Pittsburgh sleep quality index (PSQI) from baseline to the end of drug intervention. Secondary outcome measures will include the the altered sleep parameters in polysomnography, 1 H-magnetic resonance spectroscopy ( 1 H-MRS) evalution, the Disharmony of Heart and Kidney Scoring System score and blood tests, including the levels of serum adenosine and melatonin . A laboratory test will be taken before and after treatment to assess the safety of JTW. Discussion: The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms, and will also be used to monitor the safety of JTW. Trial registration : Chinese Clinical Trial Registry, ChiCTR1 800019239.Registered on 1 st November 2018- Retrospectively registered, http://www.chictr.org.cn/.

scholarly journals Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial

2019 ◽  
Author(s):  
Congcong Zeng ◽  
Xi Liu ◽  
Lufeng Hu ◽  
Yuan Feng ◽  
Nengzhi Xia ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Resonance Spectroscopy ◽  
Random Allocation ◽  
1H Mrs ◽  
Double Blind ◽  
Drug Intervention ◽  
Double Blind Placebo ◽  
Insomnia Symptoms

Abstract Background Insomnia seriously affects people’s normal lives and work. However, effective treatment strategies are scarce. The purpose of this study is to explore the efficacy and safety of Jiao-tai-wan (JTW) for ameliorating insomnia symptoms caused by disharmony of the heart and kidney. Design This is a randomized, double-blind, placebo-controlled pilot clinical trial. One hundred twenty-eight participants suffering from insomnia symptoms will randomly assigned to the JTW or placebo group in an equal ratio. The participants will be asked to take JTW or placebo granules twice a day for 1 week. All data will be gathered at baseline and at the end of the drug intervention after random allocation. The primary outcome measures will be the mean change in the Pittsburgh sleep quality index (PSQI) from baseline to the end of the drug intervention. Secondary outcome measures will include the altered sleep parameters in polysomnography, 1H-magnetic resonance spectroscopy (1H-MRS) evaluation, the Disharmony of Heart and Kidney Scoring System score and blood tests, including the levels of serum adenosine and melatonin. A laboratory test will be taken before and after treatment to assess the safety of JTW. Discussion The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms and will also be used to monitor the safety of JTW.

scholarly journals Herbs of rich-Iodine for Graves’ Hyperthyroidism Trial (the HIGHT trial): a study protocol for a randomized, double-blind, placebo-controlled, multicentre clinical trial

2021 ◽  
Author(s):  
Chenghan Gao ◽  
Xiaowei Liu ◽  
Xuefeng Guan ◽  
Qingyang Liu ◽  
Yiwen Lai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Outcome Measures ◽  
Thyroid Stimulating Hormone ◽  
Secondary Outcome ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Multicentre Clinical Trial ◽  
Chinese Herbal ◽  
Stimulating Hormone

Abstract BackgroundGraves' hyperthyroidism is one of the refractory diseases in endocrinology. Thionamides are known to be effective and its common side-effects are markedly reduced when starting with low dose. Iodine-rich Chinese herbal decoction (IRH) is a frequently prescribed Chinese herbal medicine in patients with Graves' hyperthyroidism. However, high quality clinical evidence is still very scarce, which made the Traditional Chinese Medical (TCM) management of Graves' hyperthyroidism remains controversial. The objective of this study is to prove that IRH might get faster and longer lasting remission and improved quality of life (QoL) in Graves' hyperthyroidism patients compared with methimazole (MMI) .Methods/designThis study is a randomized, double-blind, placebo-controlled and multicentre clinical trial. We will recruit a total of 240 participants with Graves' hyperthyroidism who have any common ATD-associated side-effects. They will be randomized (1:1:1) to receive (ⅰ) IRH plus MMI placebo, (ⅱ) IRH placebo plus MMI and (ⅲ) IRH plus MMI for 12 weeks. The primary outcome measures will be the serum free triiodothyronine (FT3), free thyroxine (FT4) levels and serum thyroid-stimulating hormone (TSH) level. Secondary outcome measures will include the level of thyroid stimulating hormone-receptor antibodies (TRAb), thyroid ultrasound (US) and Thyroid-specific Patient Reported Outcome(ThyPRO39).DiscussionThe outcomes of this study will provide new evidence for the efficacy and safety of IRH for the treatment of Graves' hyperthyroidism and will also guide physicians at clinics more clearly in prescribing IRH.Trial registration number:ChiCTR, ChiCTR2000032706. Registered 7 May 2020, http://www.chictr.org.cn

scholarly journals A Herbal Medicine,Gongjindan, in Subjects with Chronic Dizziness (GOODNESS Study): Study Protocol for a Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial for Effectiveness, Safety, and Cost-Effectiveness

2017 ◽  
Vol 2017 ◽  
pp. 1-10 ◽  
Author(s):  
Seungwon Shin ◽  
Jinyoung Kim ◽  
Ami Yu ◽  
Hyung-Sik Seo ◽  
Mi-Ran Shin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cost Effectiveness ◽  
Study Protocol ◽  
Secondary Outcome ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Parallel Group ◽  
Life Years ◽  
Laboratory Test Results ◽  
Chronic Dizziness

This study protocol aims to explore the effectiveness, safety, and cost-effectiveness of a herbal medication,Gongjindan(GJD), in patients with chronic dizziness. This will be a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, clinical trial. Seventy-eight patients diagnosed with Meniere’s disease, psychogenic dizziness, or dizziness of unknown cause will be randomized and allocated to either a GJD or a placebo group in a 1 : 1 ratio. Participants will be orally given 3.75 g GJD or placebo in pill form once a day for 56 days. The primary outcome measure will be the Dizziness Handicap Inventory score. Secondary outcome measures will be as follows: severity (mean vertigo scale and visual analogue scale) and frequency of dizziness, balance function (Berg Balance Scale), fatigue (Fatigue Severity Scale) and deficiency pattern/syndrome (qi blood yin yang-deficiency questionnaire) levels, and depression (Korean version of Beck’s Depression Inventory) and anxiety (State-Trait Anxiety Inventory) levels. To assess safety, adverse events, including laboratory test results, will be monitored. Further, the incremental cost-effectiveness ratio will be calculated based on quality-adjusted life years (from the EuroQoL five dimensions’ questionnaire) and medical expenses. Data will be statistically analyzed at a significance level of 0.05 (two-sided). This trial is registered with ClinicalTrials.govNCT03219515, in July 2017.

scholarly journals Golden plaster for pain therapy in patients with knee osteoarthritis: study protocol for a multicenter randomized, double-blind, placebo-controlled trial

Trials ◽  
2013 ◽  
Vol 14 (1) ◽  
pp. 383 ◽  
Author(s):  
Jin-Tao Liu ◽  
De-Zhi Tang ◽  
Xiao-Feng Li ◽  
Zhi-Gang Zhang ◽  
Wan-Bo Ji ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Study Protocol ◽  
Pain Therapy ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals Methotrimeprazine versus haloperidol in palliative care patients with cancer-related nausea: a randomised, double-blind controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e029942 ◽  
Author(s):  
Janet Rea Hardy ◽  
Helen Skerman ◽  
Jennifer Philip ◽  
Phillip Good ◽  
David C Currow ◽  
...  
Keyword(s):  
Palliative Care ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Response Rates ◽  
Complete Response ◽  
Response To Treatment ◽  
Secondary Outcome ◽  
Double Blind ◽  
Intention To Treat ◽  
Point Reduction

ObjectivesMethotrimeprazine is commonly used for the management of nausea but never tested formally against other drugs used in this setting. The aim was to demonstrate superior antiemetic efficacy.DesignDouble-blind, randomised, controlled trial of methotrimeprazine versus haloperidol.Setting11 palliative care sites in Australia.ParticipantsParticipants were >18 years, had cancer, an average nausea score of ≥3/10 and able to tolerate oral medications. Ineligible patients had acute nausea related to treatment, nausea for which a specific antiemetic was indicated, were about to undergo a procedure or had received either of the study drugs or a change in glucocorticoid dose within the previous 48 hours.InterventionsBased on previous studies, haloperidol was used as the control. Participants were randomised to encapsulated methotrimeprazine 6·25 mg or haloperidol 1·5 mg one time or two times per day and assessed every 24 hours for 72 hours.Main outcome measuresA ≥two-point reduction in nausea score at 72 hours from baseline. Secondary outcome measures were as follows: complete response at 72 hours (end nausea score less than 3), response at 24 and 48 hours, vomiting episodes, use of rescue antiemetics, harms and global impression of change.ResultsResponse to treatment at 72 hours was 75% (44/59) in the haloperidol (H) arm and 63% (36/57) in the methotrimeprazine (M) arm with no difference between groups (intention-to-treat analysis). Complete response rates were 56% (H) and 51% (M). In theper protocolanalysis, there was no difference in response rates: (85% (44/52) (H) and 74% (36/49) (M). Completeper protocolresponse rates were 64% (H) and 59% (M). Toxicity worse than baseline was minimal with a trend towards greater sedation in the methotrimeprazine arm.ConclusionThis study did not demonstrate any difference in response rate between methotrimeprazine and haloperidol in the control of nausea.Trial registration numberACTRN 12615000177550.

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