HIV Infections Clinical Trial
Official title:
Phase III Clinical Studies on Traditional CAM Therapy in the Treatment of HIV/AIDS
Verified date | March 2017 |
Source | Traditional Alternative Medicine Research, India |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research work is important for the cure/control of HIV infection. The study is intended
to confirm the efficacy of "Kallunk Oxide (Immunotherapy)" molecules in the Treatment of HIV
infection. The study will investigate the T- Lymphocytes (immune) response to HIV in order
to boost the body's natural immune ability against infection. The basic study is directly
inhibit a protein's increased functions, not only in the CD4+T cell but also CD3+ and CD8+ T
cells and the CD45+. cells.
The 'Yogaprabhava', the drug's effectiveness, and progressive immunity with diet and
lifestyle can be more easily studied.
Status | Completed |
Enrollment | 1000 |
Est. completion date | February 27, 2017 |
Est. primary completion date | February 27, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of HIV/AIDS - Able to swallow tablets or powder form medicine - Able to eat nutritional foods - HIV infected patients - Signed consent of parent or guardian for patients under 18 years of age - Interest to use of study drugs - Follow at a participating clinical site and - Children greater than 8 years old. Exclusion Criteria: - Medical side effects - Pregnant or breast feedings - History of significant cardiac abnormalities or dysfunction - Received certain drugs (Steroid) or treatments - Unable to followed at a participating clinical center - Children less than 8 years old - Any serious conditions (severe chronic stage AIDS cases) at study entry that may affect the results of the study. - Allergy to any of the study drugs or their formulations - Tobacco using patients - Alcohol using patients and - Drug addicting patients. |
Country | Name | City | State |
---|---|---|---|
India | Project Site Office, Hospital of Integrated Research Site HIRS(New), Karoor, Ambalapuzha-PO, Alleppey-District, Kerala, India 688561 | Alleppey | |
India | Project Site Office, Hospital of Integrated Research Site HIRS(New), Ahammed Nagar, Mathura Nagar, Bhingar- PO | Mumbai | |
India | Project Site Office, Near Sivan Kovil, Nallepily, Hospital of Integrated Research Site HIRS [new]) | Palakkad | Kerala |
Lead Sponsor | Collaborator |
---|---|
Traditional Alternative Medicine Research, India |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy | Number of participants with adverse events for efficacy by mentioned time frame will be assessed. | Number of Participants with Adverse Events by weeks 24 | |
Secondary | Viral Load Assay | Three months follow up | ||
Secondary | Absolute Immune Cells Count Assay(CD3, CD4, and CD8 + T cells) | Three months follow up study | ||
Secondary | Prolonged Viral Suppression | Six Month's Follow up study |
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