A Randomized Double-Blinded and Placebo-Controlled Trial to Assess the Efficacy of Biophoton Therapy to Treat Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- Fasting Glucose
研究概览
简要总结
Study Objective The purpose of this clinical study is to evaluate if biophoton therapy, delivered by Tesla BioHealing® Biophoton Generators (Biophotonizer), can treat diabetes.
Study Design This is a randomized, double-blind, placebo-controlled intervention clinical study to assess the effectiveness of biophoton therapy in treating diabetes. Approximately 46 volunteers will participate in the study.
Study Randomization The biostatistician will prepare a randomization schedule including a serial of subject numbers. A subject number will be randomly assigned to each study participant, which will assign them to either the control group or the treatment group. This phase lasts for 4 weeks. At the end of Week 4, the active devices will replace the placebo. Both groups will be actively participating in the study for 2 months (8 weeks).
Other than the Informed Consent Form (ICF), all study information will be recorded by using the subject number.
The Principal Investigator, study physicians, study nurses, data-entry specialists, and biostatisticians, as well as the participants, will be blinded about who received which product during the first two weeks of study participation.
Study Enrollment Each potentially qualified volunteer will review the Informed Consent Form online (e-ICF) and Enrollment Criteria online (e-Criteria) first, then discuss the e-ICF and e-Criteria with the study team medical professional via telephone during the scheduled time. Each qualified volunteer will sign the e-ICF and send it to the Medical Office Coordinator. The study coordinator will assign the qualified volunteer a randomized subject number, then the volunteer will become a study participant.
详细描述
Study Procedure We expect that participants will remain in this clinical treatment for two months. The first 4 weeks of participation are double-blinded to record the placebo effects, as each set of the study device is labelled with a unique code for use by only one participant. The change of the placebo device to the treatment device will be performed by the study device management team staff, who will not inform the study participant or the study research staff who are involved in study data collection. Each participant assigned to the Control Group will be treated with 8 placebo devices, with two devices placed on the 2 sides of the bed. Each participant assigned to the Treatment Group will receive 8 Biophoton generator Biophotonizer- A devices and placed on the 2 sides of the bed. Each participant will use the Treatment or Control device for at least 8 hours every night for 8 weeks during sleep. During the day, participants are welcome to bring the study devices and place them near their bodies. At the end of the initial 4 weeks, study participants randomized to the Placebo group will be switched to the Open-Label product to treat them for 1 month (4 weeks).
Each participant will be guided by study team staff to perform the following tests on their assigned testing days: the standard SF-36 questionnaires (SF-36) for measuring life quality, and other study indicators, respectively, at the Baseline, bi-weekly after using the study devices.
Study Supply The 8 study devices (Placebo or Treatment) will be packed inside the two specially made black carriers for easy use.
Each participant will use the assigned devices during the first 4-week randomized period. The active devices will be used for 8 weeks, during the active treatment period in the Treatment Group, and 4 weeks in the Control Group.
Study Patient Population An adult who is clinically diagnosed with diabetes mellitus type 2 (DM2) can participate in this clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The same shape, size, and weight of the device without generating biophoton is to be labeled with a random code and used as a comparator. The comparator device will be packed and used in the same way as the Treatment devices. Each two units will be packed inside a black container. Each package will be placed on each side of the bed and used during night sleep. The 8 study devices will be used during the entire study period.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to give informed consent for participation in the trial.
- •Is able and willing to comply with all trial requirements.
- •Male or female aged 18-70 years old without major diseases.
- •An adult clinically diagnosed with DM2
- •Participants must not be heavy users of Tesla BioHealing devices; enrollment will be determined by the clinical team based on an evaluation of the participant's prior device usage.
- •Must be fluent in English.
排除标准
- •Untreated psychiatric disturbances that would affect trial participation as judged by research medical professionals.
- •Is participating in another investigational drug or device trial
研究组 & 干预措施
Placebo
The same size, shape, and weight of the devices without emitting biophotons will be provided and used during the first 4 weeks of the randomized study period.
干预措施: Biophoton Generators (Device)
Treatment
Eight Tesla Biophotonizer-A will be packed in 4 sleeves and used during the study. The Placebo will be packed the same way without emitting biophotons.
干预措施: Biophoton Generators (Device)
结局指标
主要结局
Fasting Glucose
时间窗: [Time Frame: baseline, 0-4, and 0-8 weeks]
Fasting Glucose at Baseline, Week 4, and Week 8
次要结局
- Blood Lipids([Time Frame: baseline, 0-4, and 0-8 weeks].)
- Biomarkers of aging([Time Frame: baseline, 0-4, and 0-8 weeks])
- Sugar Attachment (HbA1c)([Time Frame: baseline, 0-4, and 0-8 weeks])
- Stem cell counts([Time Frame: baseline, 0-4, and 0-8 weeks])
- Blood Flow Assessment([Time Frame: baseline, 0-4, and 0-8 weeks])