Autoimmune DiseasesPhase 1NCT05196295
To Evaluate the Safety of Treating Rheumatologic and Metabolic Patients With Molecular Hydrogen Supplement.
A Phase 1 study testing Hydrogen in people with Autoimmune Diseases and Metabolic Disease, run by HoHo Biotech at 1 site in Taiwan.
Trial summary
The latest international research shows that supplementation of hydrogen molecules as an aid, adjuvant, can speed up the course of the disease. The purpose of this study is to determine the safety and possible efficacy of hydrogen supplements in different dose exposures for a clinical study in rheumatologic and… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Autoimmune Diseases, Metabolic Disease
- What is being tested?
- Hydrogen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Jan 2022to 30 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 to 70 with autoimmune or metabolic diseases
- Able to compliant with the protocol
- Able to return to the hospital regularly
Who cannot join
- Pregnancy
- Expected pregnancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Min-Sheng Gereral hospital
Taoyuan
Wen-Wen Chen, 03 479 4151 ext. 5506, N002737@e-ms.com.tw
Min-Chung Shen, M.D.
About this study
Official title: To Evaluate the Safety of Treating Rheumatologic and Metabolic Patients With 3 Increasing Doses of Molecular Hydrogen Supplement.
The latest international research shows that supplementation of hydrogen molecules as an aid, adjuvant, can speed up the course of the disease. The purpose of this study is to determine the safety and possible efficacy of hydrogen supplements in different dose exposures for a clinical study in rheumatologic and metabolic patients. Patients will receive a different dosage of hydrogen capsules with their conventional treatment for a month. Investigators will test for any changes in haematologic, urine analysis and health status during and following the exposure period.
Read the detailed description
According to the current literature, there is a lack of specific drugs for chronic inflammatory symptoms which develop from many refractory diseases with complicated clinical features. Hydrogen supplement has been shown to have significant removal effects on free radicals and reduce chronic inflammation. With these benefits, molecular hydrogen may have the ability to speed up the recovering the disease.
The purpose of this study is to determine the safety and possible efficacy of hydrogen supplements in the different doses of hydrogen capsules for a clinical study in rheumatologic and metabolic patients.
Study design: 15 rheumatologic patients and 15 metabolic patients will be recruited from the Min-Sheng General Hospital for this study. Participants will be screened by doctors for their eligibility and undergo a series of tests (questionnaires and examinations). Consenting participants will then be allocated into 3 groups by different dosage (Low, n=5; Medium, n=5; High, n=5). Participants will receive 1 (Low), 3 (Medium) or 6 (High) capsules every day for one month. Participants will be examined their regular haematology, urine and health status before and after the intervention.
- Conditions
- Autoimmune Diseases, Metabolic Disease
- Being tested
- Hydrogen
- Medical subject headings
- Autoimmune Diseases, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrogenDrug
Participants take either 1 (n=5), 3 (n=5) or 6 (n=5) capsules every day for one month.
| Study group | Role | What they receive |
|---|---|---|
| Hydrogen capsules | Experimental | Participants will be allocated by doctors and receive either 1 (n=5), 3 (n=5) or 6 (n=5) capsules every day for one month. Receives: Drug: Hydrogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse effects/symptoms
Any adverse effects will be codified according the the NCI CTCAE v5.0
Measured: up to 28 days
Secondary outcomes (4)
Change in physiological parameter (Blood Routine)
Numerical change in Blood Routine
Measured: Change from Baseline Blood Routine at Day 28
Change in physiological parameter (Urine Routine)
Numerical change in Urine Routine
Measured: Change from Baseline Urine Routine at Day 28
Brief Fatigue Inventory-Taiwan (BFI-T) (6 questions)
Questionnaire for rheumatologic patients minimum values:0 maximum values:60 Higher scores mean a worse outcome.
Measured: Change from Baseline BFI-T at Day 28
Control status scale for diabetics (CSSD70) (First part: 11 questions)
Questionnaire for metabolic patients minimum values:0 maximum values:22 Higher scores mean a worse outcome.
Measured: Change from Baseline CSSD70 at Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start11 Jan 2022
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HoHo Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196295
- Sponsor's protocol ID
- 2021007-A
- Status last verified
- Jan 2022
- First submitted
- 3 Jan 2022
- Last updated
- 10 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chiu SH, Douglas FL, Chung JR, Wang KY, Chu CF, Chou HY, Huang WC, Wang TY, Chen WW, Shen MC, Liu FC, Hsiao PJ. Evaluation of the safety and potential lipid-lowering effects of oral hydrogen-rich coral calcium (HRCC) capsules in patients with metabolic syndrome: a prospective case series study. Front Nutr. 2023 Jul 14;10:1198524. doi: 10.3389/fnut.2023.1198524. eCollection 2023.
PubMed 37521410
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Safety of Treating Rheumatologic and Metabolic Patients With 3 Increasing Doses of Molecular Hydrogen Supplement.
- ClinicalTrials.gov ID
- NCT05196295
- Acronym / sponsor ID
- 2021007-A
- Conditions
- Autoimmune Diseases, Metabolic Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- HoHo BiotechIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The latest international research shows that supplementation of hydrogen molecules as an aid, adjuvant, can speed up the course of the disease. The purpose of this study is to determine the safety and possible efficacy of hydrogen supplements in different dose exposures for a clinical study in rheumatologic and metabolic patients. Patients will receive a different dosage of hydrogen capsules with their conventional treatment for a month. Investigators will test for any changes in haematologic, urine analysis and health status during and following the exposure period.
Detailed description
According to the current literature, there is a lack of specific drugs for chronic inflammatory symptoms which develop from many refractory diseases with complicated clinical features. Hydrogen supplement has been shown to have significant removal effects on free radicals and reduce chronic inflammation. With these benefits, molecular hydrogen may have the ability to speed up the recovering the disease.
The purpose of this study is to determine the safety and possible efficacy of hydrogen supplements in the different doses of hydrogen capsules for a clinical study in rheumatologic and metabolic patients.
Study design: 15 rheumatologic patients and 15 metabolic patients will be recruited from the Min-Sheng General Hospital for this study. Participants will be screened by doctors for their eligibility and undergo a series of tests (questionnaires and examinations). Consenting participants will then be allocated into 3 groups by different dosage (Low, n=5; Medium, n=5; High, n=5). Participants will receive 1 (Low), 3 (Medium) or 6 (High) capsules every day for one month. Participants will be examined their regular haematology, urine and health status before and after the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydrogen capsules | Experimental | Drug: HydrogenParticipants will be allocated by doctors and receive either 1 (n=5), 3 (n=5) or 6 (n=5) capsules every day for one month. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 20 to 70 with autoimmune or metabolic diseases
- Able to compliant with the protocol
- Able to return to the hospital regularly
Key exclusion criteria (2 listed)
- Pregnancy
- Expected pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrogenParticipants take either 1 (n=5), 3 (n=5) or 6 (n=5) capsules every day for one month. | Drug | Hydrogen capsules |
Primary outcome
Adverse effects/symptoms
Time frame: up to 28 days
Any adverse effects will be codified according the the NCI CTCAE v5.0
4 secondary outcomes
Change in physiological parameter (Blood Routine)
Time frame: Change from Baseline Blood Routine at Day 28
Change in physiological parameter (Urine Routine)
Time frame: Change from Baseline Urine Routine at Day 28
Brief Fatigue Inventory-Taiwan (BFI-T) (6 questions)
Time frame: Change from Baseline BFI-T at Day 28
Control status scale for diabetics (CSSD70) (First part: 11 questions)
Time frame: Change from Baseline CSSD70 at Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Derived from this study: PubMed 37521410Chiu SH, Douglas FL, Chung JR, Wang KY, Chu CF, Chou HY, Huang WC, Wang TY, Chen WW, Shen MC, Liu FC, Hsiao PJ. Evaluation of the safety and potential lipid-lowering effects of oral hydrogen-rich coral calcium (HRCC) capsules in patients with metabolic syndrome: a prospective case series study. Front Nutr. 2023 Jul 14;10:1198524. doi: 10.3389/fnut.2023.1198524. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hydrogen in people with Autoimmune Diseases and Metabolic Disease, run by HoHo Biotech at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kuang-Yih Wang, M.D. (+886 920757313, bbban1024@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse effects/symptoms (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05196295, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.