Clinical Testing Services for Traditional Medicine at the Academy of Medical Sciences

Clinical trials are a crucial stage in the research and development process for medicines, ensuring the safety and efficacy of products before they are widely used. For traditional medicine, this stage is even more significant as these medicines are often based on ancient formulations. The combination of these traditional practices with modern methods ensures they meet contemporary medical standards.

At the Academy of Medical Sciences, clinical trials for traditional medicine not only aim to verify quality but also provide opportunities for in-depth research into the effects, dosages, and mechanisms of action of various herbal formulations in treating specific diseases.

The Role of the Academy of Medical Sciences in Clinical Trials

The Academy of Medical Sciences is a leading institution in Vietnam for medical research, encompassing both traditional and modern medicine. With a team of experienced experts, state-of-the-art facilities, and the integration of traditional practices with advanced technologies, the academy has been conducting numerous clinical trial projects to evaluate and develop traditional medicines.

Its primary roles in this area include:

1. Ensuring safety: Verifying that the medicine does not cause severe side effects when used.
2. Confirming efficacy: Assessing the medicine's ability to treat specific illnesses.
3. Standardizing procedures: Providing detailed guidelines on dosage, administration, and appropriate patient groups.
4. Enhancing the value of traditional medicine: Combining traditional practices with modern medical methods to produce high-quality products recognized internationally.

The Clinical Trial Process at the Academy of Medical Sciences

Clinical trials for traditional medicines at the Academy of Medical Sciences are conducted in strict stages, including:

1. Preclinical Research

This phase focuses on animal models and chemical analysis to determine initial safety. Activities include:

• Testing for acute and chronic toxicity.
• Investigating the biological mechanisms of key components.
• Determining optimal dosages for human trials.

2. Phase I Clinical Trials

The goal of this phase is to evaluate the safety of the medicine on a small group of healthy volunteers (about 20–80 participants). Key indicators measured include:

• Side effects.
• Physiological and biochemical changes in the body.
• Absorption rates and half-life of the medicine.

3. Phase II Clinical Trials

In this phase, the medicine is tested on a group of patients with specific conditions (about 100–300 participants). The objective is to assess its effectiveness and continue monitoring its safety.

4. Phase III Clinical Trials

This is the most critical phase, where the medicine is tested on a large group of patients (about 1,000–3,000 participants) to compare its effectiveness with other treatment methods. Factors evaluated include:

• Success rates in treatment.
• Comparisons with placebo groups.
• Detailed recording of any side effects.

5. Phase IV Clinical Trials

After the medicine is approved for public use, this phase monitors its effectiveness in large-scale community use. It ensures the medicine continues to meet quality and safety standards.

Unique Factors in Traditional Medicine Trials

Clinical trials for traditional medicines at the Academy of Medical Sciences have distinct characteristics, such as:

1. Natural origin: Traditional medicines often contain natural ingredients, requiring rigorous extraction and testing processes to ensure purity.
2. Combination of components: Herbal formulations often involve multiple ingredients, adding complexity to analyzing their mechanisms.
3. Gradual effects: Unlike modern medicines, which often have immediate results, traditional medicines work gradually, requiring long-term monitoring for accurate evaluation.

Facilities and Expertise

The Academy of Medical Sciences boasts modern laboratories that meet international standards. Additionally, its team includes:

• Traditional medicine experts: Experienced in research and treatment using ancient herbal formulations.
• Biological researchers: Analyzing the mechanisms of medicines at the cellular level.
• Clinical specialists: Monitoring and documenting trial results on patients.

Notable Projects

The Academy of Medical Sciences has conducted numerous successful clinical trial projects for traditional medicines, including:

• Treatment for Hepatitis B: Using components from Phyllanthus and Adenosma caeruleum, achieving an 80% improvement in liver function.
• Supportive treatment for diabetes: A formulation combining bitter melon and Gymnema sylvestre proved effective and safe in lowering blood sugar levels.
• Pain relief from Polyscias fruticosa (Vietnamese ginseng): Effective in treating musculoskeletal pain without side effects typically associated with modern pain relievers.

Importance of Clinical Trials for Traditional Medicine

Clinical trials not only help standardize ancient herbal formulations but also elevate the value and status of traditional medicine within modern healthcare. Through the Academy of Medical Sciences’ clinical trial projects, traditional medicine products have gained international recognition, creating opportunities to expand into global markets.

Conclusion

The clinical testing services for traditional medicine at the Academy of Medical Sciences not only help develop high-quality products but also promote the integration of Vietnamese traditional medicine into the global medical community. The synergy of modern science with traditional practices is the key to advancing traditional medicine to a higher level, serving better healthcare for all.