Research on Effect of Traditional Chinese Medicine (TCM) on Immune Reconstitution of HIV/AIDS Patients After Highly Active Antiretroviral Therapy (HAART)
Recruitment status was Recruiting
Chinese prescriptions can inhibit viral replication according to the course of viral replication, and the effects is similar to the effect of HAART, and even better than the anti-viral and immune reconstitution of HAART due to its effect on improve immune system function. Over the past decades, many researchers have screened the effective Chinese medicines to treat AIDS.
Acquired Immune Deficiency Syndrome Virus
Drug: Fuzheng 2
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Research on Effect of TCM on Immune Reconstitution of HIV/AIDS Patients After HAART|
- Peripheral blood CD3+ CD4+ counts [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Immune reconstitution efficiency [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Viral load [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Clinical symptoms and signs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- KPS score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Quality of life score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Side effects of HAART [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Safety evaluation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Economic evaluation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Fuzheng 2
Immunity 2 (Fuzheng 2), 6.25g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
Drug: Fuzheng 2
Placebo Comparator: Placebo
Placebo, 6.25g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.
- There is no record of AIDS in Chinese medicine, modern clinicians hold that AIDS is linked to TCM theory according to its pathogenesis, character of onset and clinical manifestations. As early as more than 2000 years ago, there were records of immune function in TCM. 2 TCM books recorded that "keep vital Qi, the evil will not invade the body "and" the invasion of evil is caused by the deficiency of vital Qi. Vital Qi summarizes the normal immune system function. Vital Qi is the basic material and physiological function which can eliminate the evil, regulating yin and yang and protect the body.
- And this is in accordance with defense, homeostasis and surveillance of immune system in western medicine. The knowledge of immunology has guided medical practice in China for more than two thousand years. In response to a variety of immune diseases, there are various immunotherapy such as Yiqi Fuzheng immunotherapy, reinforce kidney therapy, huoxuehuayu therapy and heat-clearing and detoxifying therapy. Throughout the course of AIDS, the evil (HIV) exists and the vital Qi is turning weak gradually. If we adopted a number of intervention measures to assist the body's Vital Qi, Vital Qi will be strengthened and the evil will be weakened. Therefore, TCM will play an important role in improving immune function.
Researchers screened single Chinese herbs, some extract and the effective components of Chinese medicine and prescriptions. Some study the role of its anti-HIV, some study the role of its regulating immunization function. The former studies have shown that immunization 2 (Fuzheng 2) has wide effect on immune system and it can activate the reticuloendothelial system, macrophage phagocytes and lymphocyte transformation. And it can relieve disorders, imbalance of the immune system caused by HIV infection.
- In addition, this prescription can inhibit HIV reverse transcription polymerase enzyme and virus-induced syncytium formation, protect virus-infected cells, and inhibit virus replication in HIV-1 infected cells.
- Through the clinical trials, we will evaluate the effect of immune 2 (Fuzheng 2) on immune reconstitution of adult HIV/AIDS patients who have received HAART.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974454
|Contact: Jie Liu, MDemail@example.com|
|Guang'anmen Hospital of China Academy of Chinese Medical Sciences||Recruiting|
|Beijing, Beijing, China, 100053|
|Contact: Jie WANG, MD 8610-88001381 firstname.lastname@example.org|
|Study Chair:||Jie WANG, MD||Guang'anmen Hospital of China Academy of Chinese Medical Sciences|