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临床试验/NCT06855459
NCT06855459已完成不适用

A Randomized Double Blinded and Placebo-Controlled Trial to Assess the Impact of Biophoton Therapy on Self-Grown Stem Cells

First Institute of All Medicines4 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2025年2月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
71
试验地点
4
主要终点
Changes in Self-Grown Stem Cells Count

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 increase self-grown stem cells naturally.

Study Design This is a randomized, double-blinded, placebo-controlled intervention clinical study to assess the effectiveness of biophoton therapy in impacting stem cells. Approximately 46 volunteers who want to increase self-grown stem cells 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.

Other than the Informed Consent Form (ICF), all study information will be recorded by using the subject number. The Principal Investigator, study physicians, study nurse, 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.

详细描述

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 Coordinator will assign the qualified volunteer a randomized subject number, then the volunteer will become a study participant.

Study Procedure We expect that the participant will stay in this clinical treatment for 2 weeks, or 4 weeks if the participants are randomly placed in a placebo group. The first 2 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 nor study research staff who involve study data collection. Each participant assigned to the Control Group will be treated with the 4 placebo devices and placed on the 4 corners of the bed. Each participant assigned to the Treatment Group will receive 4 Biophoton generator devices and placed on the 4 corners of the bed. Each participant will use the Treatment or Control device for at least 8 hours every night for the 2 weeks during sleep. During the day, participants are welcome to bring the study devices and place them near the body during the daytime. At the end of the initial 2 weeks, study participants randomized to the Placebo group will be advised whether they will use the Open-Labeled product to treat them for 2 weeks. Each participant will be guided by study team staff to perform the following tests on their assigned testing days: a visual analog scale of pain, the standard SF-36 questionnaires (SF-36) for measuring life quality, and stem cell examination respectively at the Baseline, one and two weeks after using the study devices.

Study Supply All study devices (Placebo or Treatment) will be packed for easy use. Each participant will use the assigned devices during the 2-week study period (Treatment Group), or for 2+2 weeks (Placebo Group) after being switched to the Treatment group after the first two weeks of the placebo period.

Study Patient Population The adult who wants to increase stem cells without major health issues.

Investigational Product and Mode of Administration Tesla BioHealing Biophotonizer-A is an over-the-counter (OTC) medical device and it can be used by anyone who wants to increase blood circulation and reduce bodily pains. For this study, the active or inactive Biophotonizer-A will be labeled with a code. The participant and/or caregiver cannot know if the devices are active or inactive. When the participant places the devices close to the body, she/he may or may not receive life force energy. The participant will record changes in pain, quality of life at baseline and at the end of each week.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Each set of the study device is labelled with a unique code for use by only one participant. Participant, investigator data analyzer are all blinded.

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

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 ages 18-70 years old without major diseases.
  • 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 the research medical professional.
  • Is participating in another investigational drug or device trial
  • Had been treated with Stem Cell therapy within a 6-month period.

研究组 & 干预措施

Placebo Control

Placebo Comparator

Each participant assigned to the Control Group will be treated with the 4 placebo devices

干预措施: Biophoton Generators (Device)

Treatment

Experimental

This arm is to verify if biophoton generators can increase self-grown stem cells as previously observed that using Tesla BioHealers for 2 weeks the self-grown stem cells increased by 346%. BioHealing Biophotonizer-A had been used to increase is an over-the-counter (OTC) medical device and it can be used by anyone who wants to increase blood circulation and reduce bodily pains. For this study, the active Biophotonizer-A will be labeled with a code. The participant cannot know if the devices are active or inactive. When the participant places the devices close to the body, she/he may or may not receive life force energy. The participant will record changes in pain, quality of life at baseline and at the end of each week. A total of 23 participants will be enrolled in this group.

干预措施: Biophoton Generators (Device)

结局指标

主要结局

Changes in Self-Grown Stem Cells Count

时间窗: [Time Frame: baseline, 0-2, 0-4 weeks].

To determine if treatment with Biophoton Generator can impact self-grown steam cells naturally

次要结局

  • Quality of Life Short Form -36 (SF-36) -the function and well-being of a person([Time Frame: baseline, 0-2, 0-4 weeks].)
  • Impact of Biophoton Treatment on Pain Disability Index([Time Frame: baseline, 0-2, 0-4 weeks].)

研究者

发起方
First Institute of All Medicines
申办方类型
Other
责任方
Sponsor

研究点 (4)

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