氢气生物学研究目前进展迅速，虽然有大量的动物实验证明对许多疾病具有治疗作用，但如果没有严格的随机对照临床试验的证据，则无法获得临床治疗特别是国家医药管理局等的最终许可，也就是说无法获得官方的正式批准用于临床的使用。开展严格对照的临床研究是氢气医学发展最重要的任务和手段。也是将来深入研究氢气生物学效应最重要的环境保障和研究目的。

但国际上在临床试验方面进展并不快，到目前为止，临床试验的报道基本都来自日本，这里是从世界卫生组织临床试验注册的信息中检索到的临床试验注册信息也说明这个问题，这些信息显示出日本在神经系统损伤治疗方面的关注度比较大，例如6项注册试验中有3项属于神经系统损伤治疗效果的研究，分别是中风、巴金森病和中度认知障碍的研究。比较有意思的是，最早报道氢气生物学效应的日本医科大学没有注册临床试验的信息，是他们没有信心，还是没有获得研究经费的资助。因为他们曾经获得来自商业公司的赞助，并成立氢气医学中心。从这一点上看，似乎没有这些问题。但内情不清楚。

第一项：氢气水治疗巴金森病

第二项：氢气水对正常人的抗氧化效果评价

第三项 氢气生理盐水注射对脑缺血的治疗效果评价

第四项 氢气水对中度认知障碍治疗效果的研究

第五项 氢气水治疗间质性膀胱炎

第六项 氢气水对糖尿病的治疗效果评价

所有信息可从世界卫生组织的临床试验注册网上免费检索，更详细的信息可从http://apps.who.int/trialsearch/AdvSearch.aspx

检索。建议检索词为：hydrogen。Recruitment status选择ALL。否则无法获得全面的信息。

详细信息

第一项：氢气水治疗巴金森病

2012年3月14日注册的用“氢气水治疗巴金森病”开始实验2010年1月1日顺天堂大学附属医院神经外科，联系人Asako Yoritaka。日本学者曾经报道使用氢气水治疗巴金森病的动物实验效果，发表论文3篇。全部使用自由饮用氢气水。治疗设计The subjects should make 1000 ml of molecular hydrogen water which contains 1.6 ppm dissolved hydrogen by Aquerable, and consume for 48 weeks. Placebo water which is not contained molecular hydrogen water made from pseudo-machine. The subjects consume for48 weeks.

第二项：氢气水对正常人的抗氧化效果评价

Studies on in vivo effects of drinking a water product dissolving hydrogen gas as an in vitro antioxidant additive

杏林大学Atsushi Hiraoka自2009年5月1日开始的针对健康人的一项研究，排除肝脏肾脏功能异常和月经期女性。Ingestion of 500ml per day of hydrogen gas-dissolving water for 1 week.Ingestion of 500ml per day of control water without hydrogen gas for 1 week..观察指标the levels of serum LPO and urine 8-OHdG in subjects immediately before and after 1-week drinking period for 500ml per day of tap water with or without dissolved hydrogen gas at 0.34mg/l and 1-week before and after the drinking per day.

第三项 氢气生理盐水注射对脑缺血的治疗效果评价

日本国防医科大学神经外科Hiroshi Nawashiro于2011/06/01开始的Molecular hydrogen for ischemic stroke。选择诊断后症状发生24小时内脑缺血患者Patients were eligible for enrollment if they were 18 years or older and had a clinical diagnosis of acute ischemic stroke within 24 hours of symptom onset. They had to score at least 6 on the National Institutes of Health Stroke Scale (NIHSS) with at least 2 points for limb weakness. All patients received appropriate routine stroke care as per local treatment practices, including alteplase for eligible patients presenting 3 hours from onset; patients receiving alteplase had to commence the study drug before the alteplase infusion.Exclusion criteria: Patients with acute ischemic stroke beyond 24 hours of symptom onset.治疗方法为静脉点滴注射氢气生理盐水。效果评价modified Rankin scale (mRS) (days 7, 30, and 90), the NIHSS (days 7 and 90), and the Barthel Index (days 7, 30, and 90)

Safety Assessments

Vital signs were recorded at enrollment and at specified times throughout the infusion and follow-up periods. Routine laboratory data and ECGs were performed at the time of enrollment, at 24 and 72 hours, and on day 7 and were analyzed centrally (ECGs at day 7 were performed only if abnormal at 72 hours). To assess any effect of hydrogen on hemorrhagic transformation after alteplase administration, brain imaging was repeated after 72 hours in patients who were receiving concomitant treatment with alteplase. Symptomatic hemorrhagic transformation was defined as an increase in the NIHSS score of at least 4 points within 36 hours, plus evidence of any blood on neuroimaging after treatment with alteplase. Patients meeting criteria for progressive stroke (NIHSS increase of 4 points within 72 hours) or new stroke in the first week were also reimaged.

第四项 氢气水对中度认知障碍治疗效果的研究

筑波医科大学临床医学研究所神经精神学系Takashi Asada2009/07/01开始的A randomized trial to assess the effects of hydrogen-ride dissolution water for the patients with mild cognitive impairment (MCI).中度认知障碍的研究。

招募对象：Inclusion criteria: 1) Participants of the Tone project. 2) Being able to give a written informed consent to the participation in the present study. 3) Having diagnosis of the mild cognitive impairment. 4) Being able to observe the following requirement: good compliance with the water; participation in the scheduled examinations for assessment; keeping a log-diary recording the consumption of the water. 5) Having a modified Hachinski Ischemic score of 4 or less. 6) Having the 15-item Geriatric Depression Scale score of 6 or less.

Exclusion criteria: 1) Meeting DSM-IV TR criteria for dementing illnesses. 2) Having serious or unstable illnesses. 3) Having a history within past 5 years of serious infectious disease affecting the brain and/or malignant diseases. 4) Having a history of alcohol or drug abuse or dependence (on DSM-IV TR) within the past 5 years. 5) Receiving any types of anti-Alzheimer drugs. 6) Recent (within 4 weeks) initiation of medications that affect the central nervous system.Age minimum: 67years-old.Age maximum: Not applicable Gender: Male and Female

研究内容：mild cognitive impairment

治疗手段The patients of hydrogen group will be intervened with 500ml hydrogen dissolution water every-day for 2 years. The patients of placebo group will be intervened with 500ml ordinary water every-day for 2 years.

效果评价Score in Japanese version of ADAS-Cog and Mini Mental State Examination. Scores in Japanese version of ADCS-ADL, MRI and SPCET imaging, and Geriatric Depression Scale.

第五项 氢气水治疗间质性膀胱炎

Koushinkai Hospital的Comprehensive Support Project for Clinical Research Office于2008/07/01开始的A randomized trial to asses the effects of hydrogen-rich dissolution water in patients with interstitial cystitis。至少现在没有氢气在间质性膀胱炎方面的研究报道，无论是动物实验还是临床报道。

研究对象标准：Inclusion criteria: 1) Patients who are able to give written informed consent

2) Patients who has the characteristic finding under hydraulic distension of the bladder in interstitial cystitis by cystoscope 3) It has taken more than 12 weeks after patients took the hydraulic distension of the bladder, and symptom of patients are in stable. 4) More than 7 marks in total of Interstitial Cystitis Score in registration 5) More than 4 marks in Q4 (degree of bladder pain) in Interstitial Symptom Score 6) Age is over 20 years and less than 80 years 7) Patients are able to do the following things in this trial; getting good compliance with intaking investigating food and coming to hospital, and writing the diary and the questionnaire accurately by themselvesExclusion criteria: 1) More than 200ml of an average voided volume at a time before the registration 2) Patients with active infection of urinary tract 3) Patients with bacterial cystitis within 12 weeks before registration 4) Patients with vaginosis 5) Patients with calculus of lower urinary tract or urethral diverticulum 6) Patients with nephrosis syndrome 7) Patients with active genital herpes 8) Patients who have operated the surgery in pelvis or its circumference and it has not taken more than 24 hours after the surgery 9) Patients with cerebrospinal disease 10) Patients with the follow disease or suspected disease; neurogenic bladder, cystitis radiation, tuberculous cystitis, cystitis with BCG, drug associated cystitis 11) Start, stop, or change of the dose of the following drugs within 4 weeks after the registration; (a) Antiphlogistic analgetic (b) Antidepressant (c) Anticholinergic drug (d) Antihistamine drug (e) Ataractic drug (f) Drug treatment for frequent urination and acraturesis (g) Steroid drug 12) Start or stop new bladder training or diet therapy within 4 weeks befor registration 13) Patients who has received bladder instillation therapy, electrical stimulation therapy, or acupuncture and moxibustion within 12 weeks before registration 14) Patients with serious hepatic or kidney damage 15) Patients with serious heart disease 16) Patients with malignant tumors which effect their general status or survival time 17) Patients with the history of serious drug-induced adverse effect 18) Patients who are in pregnancy, while breast-feeding, or have possibilities of them, or desire pregnancy in test period 19) Patients who have taken part in the her clinical research within 12 weeks 20) Patients who have taken part in the her clinical research within 12 weeks 21) Patients who are inadequate, which their physicians assessed itAge minimum: 20years-old

Age maximum: 80years-oldGender: Male and Female

治疗方法The patients will be intervened with hydrogen dissolution water group (hydrogen group) 200ml every three times in a day in 2 months (56days).After that, the patients in hydrogen dissolution water group will be transferred to the additional intervention term after the end of intervention.And after that, the patients will be randomized to withdrawal terms for more 1 month with hydrogen dissolution water or with placebo water.

The proportion of the patients who has been assessed "success" at the end of the intervention

Secondary Outcome(s) 1) Changes of the Symptom Score in Interstitial Cystitis Symptom Index(ICSI) 2) Changes of the Problem Score in Interstitial Cystitis Problem Index(ICPI) 3) An Average frequency of urination per day 4) An Average voided volume at a time 5) Degree of urge to urinate; PUF symptom score 6) Degree of bladder pain 7) Impression by patients with GRA (Global Response Assessment) 8) Urine Test; 8-OHdG in urine 9) Adverse Events (we cannot deny the association between the food and the event)

第六项 氢气水对糖尿病的治疗效果评价

研究京都大学医学院Comprehensive Support Project for Clinical Research Office于21/08/2008开始的A Randomized trial to assess the effects of hydrogen-rich dissolution water for patients with impaired glucose tolerance or impaired fasting glucose。该研究已经发表论文。

研究对象标准：

Inclusion criteria: 1) Patients who are abele to give written informed consent 2) FBS is over 100mg/dl and under 126mg/dl in registration 3) Age is over 20 years and less than 80 years 4) Type of practice: outpatient department 5) Patients are able to do the following things in this trial - getting good compliance with consuming investigational food and coming to hospital, and writing the diary and the questionnaire accurately by themselvesExclusion criteria: 1) Patients who have receive drug treatment for diabetes 2) Patients with the diseases which have possibility with impaired glucose tolerance 3) Patients with serious liver or kidney damage 4) Patients with serious heart disease or cerebrovascular disorders 5) Patients with serious disease in pancreas or blood disease 6) Patients with malignant tumors which effect their general status or survival time

7) Patients who are in pregnancy, while breast-feeding, have possibilities of them, or desire pregnancy in test period 8) Patients with alcohol abuse 9) Patients who have taken part in the her clinical research within 12 weeks 10) Patients who have taken part in the her clinical research within 12 weeks 11) Patients who are inadequate, which their physicians assessed it

Age minimum: 20years-oldAge maximum: 70years-oldGender: Male and Female

研究内容Impaired glucose tolerance or impaired fasting glucose

治疗手段The patients will be intervened with hydrogen dissolution water group (hydrogen group) 200ml every three times in a day in 3 months (84days). The patients will be intervened with normal water group (placebo group) 200ml every three times in a day in 3 months (84days)

效果评价方法1)75gOGTT(glucose);0 minute (in the fasting state),30,60,90 minutes later after loading2)Delta AUC(0-120min);The difference of the area under the plasma glucose concentration before and after administration