Diabetes Clinical Studies

Exploring the Potential of Sorghum Bicolor Supplement in Managing Type 2 Diabetes

Introduction

The global prevalence of Type 2 diabetes is a growing concern, necessitating the exploration of alternative treatments to manage this chronic condition effectively. Traditional allopathic drugs like Metformin, Daonil, and Glucophage are commonly prescribed to control blood glucose levels. However, these medications often come with side effects and long-term health implications. This has spurred interest in herbal supplements as potential alternatives. Among these, the Sorghum bicolor supplement has shown promise in initial studies. This document outlines the journey and findings of our current project aimed at providing clinical evidence that Sorghum bicolor can replace allopathic drugs in the management of Type 2 diabetes.

Initial Study Success

Our project began with a pilot study involving a single participant who had been on a combination of Metformin and Daonil for nine years. This individual transitioned to taking 250 mg of Sorghum bicolor supplement twice daily. Remarkably, their HbA1c levels stabilized within the normal range without the need for their previous medications. This initial success has laid a strong foundation for further research and has provided a compelling case for the potential efficacy of Sorghum bicolor in diabetes management.

Expanding the Study

Building on the success of the initial participant, we are now expanding the study to include nine more participants. This phase aims to gather more comprehensive data on the effectiveness and safety of the Sorghum bicolor supplement. Each participant will be carefully monitored, with regular assessments of their HbA1c levels, blood glucose levels, and overall health.

Methodology

Participant Selection

Participants are selected based on specific criteria:

Diagnosed with Type 2 diabetes.
Currently on a regimen of Metformin, Daonil, or Glucophage.
Willingness to transition to Sorghum bicolor supplement under medical supervision.
No significant comorbid conditions that could interfere with the study.

Study Design

This expanded study will employ a double-blind, randomized controlled trial (RCT) design in its later stages to ensure the reliability and validity of the findings. Initially, participants will be divided into two groups: one receiving the Sorghum bicolor supplement and the other continuing their current medication regimen. This phase will last for six months, during which participants will undergo regular health evaluations.

Monitoring and Evaluation

Participants will be closely monitored throughout the study. The following parameters will be evaluated:

HbA1c Levels: Measured at the start of the study and at regular intervals to assess long-term blood glucose control.
Fasting Blood Glucose: Checked weekly to monitor daily glucose levels.
Postprandial Blood Glucose: Measured after meals to understand the supplement’s impact on glucose spikes.
Liver and Kidney Function Tests: Conducted periodically to ensure the supplement does not adversely affect these organs.
Adverse Effects: Any side effects will be recorded and analyzed.

Preliminary Findings

Preliminary findings from the first participant have been encouraging. Their HbA1c levels have remained within the normal range without the need for Metformin or Daonil. Additionally, they reported improved overall well-being and no significant side effects. These results suggest that Sorghum bicolor has the potential to manage blood glucose levels effectively.

Regulatory Oversight

The expanded study and subsequent RCT will be conducted under the supervision of the relevant regulatory bodies. This oversight is crucial to ensure the study meets all ethical and scientific standards. Our team is working closely with regulatory authorities to secure the necessary approvals and ensure compliance with all guidelines.

Future Directions

Double-Blind Randomized Controlled Trial

The final phase of our project will be a formal double-blind, randomized controlled trial involving a larger cohort of participants. This phase will provide robust clinical evidence on the efficacy and safety of the Sorghum bicolor supplement. The trial will adhere to the highest standards of clinical research, including:

Randomization: Participants will be randomly assigned to either the supplement or control group.
Blinding: Both participants and researchers will be blinded to the group assignments to eliminate bias.
Placebo Control: The control group will receive a placebo to further validate the results.

Timeline and Milestones

The project is expected to be completed within the next two years. The timeline includes:

First Year: Expansion of the study to include nine additional participants, ongoing monitoring, and initial data analysis.
Second Year: Conducting the double-blind RCT, comprehensive data analysis, and publication of findings.

Conclusion

The potential of Sorghum bicolor supplement in managing Type 2 diabetes is a promising area of research. The initial success with our first participant provides a strong rationale for further investigation. By expanding our study and conducting a rigorous RCT, we aim to provide robust clinical evidence that this herbal supplement can serve as an effective alternative to traditional allopathic drugs like Metformin, Daonil, and Glucophage.

This project represents a significant step towards integrating traditional and natural medicine with modern clinical practices. The successful completion of this research could lead to a paradigm shift in the management of Type 2 diabetes, offering patients a natural and potentially safer alternative to current medications.

Detailed Plan and Progress

Phase 1: Pilot Study Recap

The initial pilot study began with one participant who had been managing Type 2 diabetes with Metformin and Daonil for nearly a decade. The transition to the Sorghum bicolor supplement was carefully supervised, with the participant receiving 250 mg of the supplement twice daily. Regular monitoring showed that their HbA1c levels remained within the normal range, indicating effective glucose control.

Phase 2: Expanded Study

Following the promising results of the pilot study, we are expanding our research to include nine additional participants. These participants will be selected based on their medical history and current diabetes management regimen. Each participant will follow a similar protocol as the pilot study, transitioning from their current medication to the Sorghum bicolor supplement under close supervision.

Data Collection and Analysis

Throughout the expanded study, data will be collected on various health parameters, including HbA1c levels, fasting and postprandial blood glucose, liver and kidney function, and any adverse effects. This data will be analyzed to assess the supplement's efficacy and safety.

Anticipated Challenges and Mitigation Strategies

Participant Compliance

Ensuring participant compliance with the supplement regimen and study protocols is crucial. To address this, we have implemented regular check-ins and provided detailed instructions and support to participants.

Data Variability

Individual variations in response to the supplement could affect data consistency. By increasing the sample size and using a randomized controlled trial design, we aim to mitigate this variability and obtain more reliable results.

Regulatory Hurdles

Securing regulatory approvals and maintaining compliance with guidelines can be challenging. Our team is working closely with regulatory bodies to ensure all protocols are followed, and necessary approvals are obtained.

Future Phases

Phase 3: Double-Blind Randomized Controlled Trial

The double-blind RCT will be the final and most rigorous phase of our research. This phase will involve a larger cohort of participants and will follow a stringent protocol to ensure the highest standards of clinical research.

Study Design: Participants will be randomly assigned to receive either the Sorghum bicolor supplement or a placebo. Neither the participants nor the researchers will know which group they are in, eliminating bias.

Duration: The RCT will run for 12 months, with regular health assessments and data collection throughout the study period.

Outcome Measures: The primary outcome measure will be HbA1c levels, with secondary measures including fasting and postprandial blood glucose, liver and kidney function, and adverse effects.

Expected Outcomes and Impact

If successful, this research could revolutionize the management of Type 2 diabetes by providing a natural alternative to traditional medications. The Sorghum bicolor supplement could offer several benefits, including:

Fewer Side Effects: Herbal supplements typically have fewer side effects compared to synthetic drugs.
Improved Compliance: Patients may be more willing to adhere to a natural supplement regimen.
Holistic Health Benefits: Beyond glucose control, Sorghum bicolor may offer additional health benefits, such as antioxidant and anti-inflammatory effects.

Conclusion

Our journey to demonstrate the efficacy of Sorghum bicolor supplement in managing Type 2 diabetes has been both challenging and rewarding. The initial success with our pilot participant has provided a solid foundation for further research. As we expand our study and move towards a formal double-blind randomized controlled trial, we are optimistic about the potential of this herbal supplement to offer a safe and effective alternative to traditional diabetes medications.

The completion of this project within the next two years could have a profound impact on the treatment of Type 2 diabetes, offering patients a new, natural option for managing their condition. Our commitment to rigorous scientific research and regulatory compliance ensures that our findings will be robust and reliable, paving the way for a new era in diabetes management.

If you volunteer to participate in this clinical study, please click [ here ] to complete the questionnaire which will help us to assess your eligibility and we will send our Informed consent document to complete and the details of the protocol that would be followed for the exercise.

Protocol for Prospective Participants in Clinical Studies: Jobelyn in the Treatment of Type-2 Diabetes

Eligibility Criteria and Study Procedures

Age and Gender:

Adult males and females aged 20 years and above.

Residency:

Must be residents of Lagos State, Nigeria.

Health Condition:

Latest diagnostic report showing an HbA1c reading greater than 5.5.

Self-Monitoring Capability:

Ability to measure fasting blood sugar (fsb) levels twice daily and forward these results on a weekly basis.

Consent:

A signed consent form is required for participation, detailing the study's purpose, procedures, potential risks, and benefits.

Monthly Reporting:

Provision of an HbA1c report on a monthly basis.

Completion Commitment:

Willingness to sign a compiled report at the study's conclusion.

Combination with Current Drug Regimen:

Participants will initially continue their current drug regimen in combination with the Jobelyn supplement. The study team will closely monitor participants' health indicators and will determine when it may be safe and beneficial to reduce or skip their current medications in favor of relying solely on Jobelyn for diabetes management.

Monitoring and Adjustment:

Regular monitoring will be essential during this transition phase. The study team will provide guidelines on when and how adjustments to medication can be made, based on individual health progress and in consultation with participants' healthcare providers.

Safety Measures:

Participants will be closely monitored for any adverse reactions or significant changes in their health status. Adjustments to the study protocol may be made to ensure participant safety.

Our Obligations

Supplement Provision: The Sorghum bicolor supplement, Jobelyn, will be provided free of charge for the duration of the study.

Medical Support:

Participants will have access to informed medical support to address any questions or concerns related to the supplement and its integration with their current treatment regimen.

This protocol ensures that the study accommodates participants' existing treatment plans while exploring the potential of Jobelyn as a standalone treatment for Type-2 diabetes.

It emphasizes safety and individualized care, acknowledging that adjustments to diabetes management should be made cautiously and under medical supervision.

Clinical Study Informed Consent Form

Title of Study: Investigating the Effects of Jobelyn Extract on Type-2 Diabetes Management

Principal Investigator: Health Forever Product Limited

Introduction:

You are being invited to participate in a clinical study to investigate the effects of Jobelyn supplement on the management of Type-2 diabetes. Please read this form carefully and ask any questions you may have before deciding whether to participate.

Purpose of the Study:

The purpose of this study is to determine the impact of Jobelyn supplement on the management of Type-2 diabetes, including its effects on blood sugar levels, insulin sensitivity, and overall health outcomes.

Study Procedures:

You will be required to take Jobelyn supplement as directed by the study protocol.

Participants must have the capability to measure fasting blood sugar (fsb) levels twice daily.

They must also commit to forwarding these results to the study coordinators on a weekly basis for monitoring purposes

You will undergo regular check-ups and assessments to monitor your diabetes management progress.

You will be required to maintain a record of your dietary intake and any changes in your medication or lifestyle habits during the study period.

Participants will initially continue their current drug regimen in combination with the Jobelyn supplement.

The study team will closely monitor participants' health indicators and will determine when it may be safe and beneficial to reduce or skip their current medications in favor of relying solely on Jobelyn for diabetes management.

At the end of the trial period, participants must be willing to sign a compiled report summarizing their experience and outcomes throughout the study.

Risks and Benefits:

The potential benefits of participating in this study include improved diabetes management, better understanding of the effects of Jobelyn supplement, and contributing to scientific knowledge. However, there may be risks associated with taking a new supplement, including dry throat, increased water intake

Confidentiality:

Your personal information collected during this study will be kept confidential and will only be accessed by authorized study personnel. Your data will be anonymized in any published reports or presentations.

Voluntary Participation:

Participation in this study is entirely voluntary, and you have the right to withdraw at any time without penalty or loss of benefits to which you are otherwise entitled. Your decision to participate or not will not affect your medical care.

Contact Information:

If you have any questions or concerns about the study, please contact:

Health Forever Product Limited

11, Dipeolu street, off Obafemi Awolowo way, Ikeja, Lagos

07065853550

info@healthforeverng.com

Consent:

I have read and understood the information provided in this consent form. I have had the opportunity to ask questions and have received satisfactory answers. I voluntarily agree to participate in this study.

Participant's Signature: _________________________ Date: ___________

Researcher's Signature: _________________________ Date: ___________

If you are selected to participate, the Informed consent form please download the [Informed Consent Form] and return by email attachment to info@healthforeverng.com

If you are interested in participating in this study, please download the Eligibility Form [here] and return as email attachment to :

info@healthforeverng.com