To Evaluate the Safety of Treating Rheumatologic and Metabolic Patients With Molecular Hydrogen Supplement.

NCT ID: NCT05196295

Last Updated: 2022-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-11
• Study Completion Date: 2022-07-30

Brief 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 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.

Conditions

Autoimmune Diseases; Metabolic Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Hydrogen capsules

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.

Group Type: EXPERIMENTAL

Hydrogen

Intervention Type: DRUG

Participants take either 1 (n=5), 3 (n=5) or 6 (n=5) capsules every day for one month.

Interventions

Hydrogen

Participants take either 1 (n=5), 3 (n=5) or 6 (n=5) capsules every day for one month.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 20 to 70 with autoimmune or metabolic diseases
• Able to compliant with the protocol
• Able to return to the hospital regularly

Exclusion Criteria

• Pregnancy
• Expected pregnancy

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HoHo Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Min-Sheng Gereral hospital

Taoyuan District, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Kuang-Yih Wang, M.D.

Role: CONTACT

bbban1024@gmail.com

+886 920757313

Facility Contacts

Wen-Wen Chen

Role: primary

N002737@e-ms.com.tw

03 479 4151 ext. 5506

References

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.

Reference Type: DERIVED

PMID: 37521410 (View on PubMed)

Other Identifiers

2021007-A

Identifier Type: -

Identifier Source: org_study_id