Traditional Complementary and Alternative Medicine (CAM) Therapy in the Treatment of HIV/AIDS
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.
The 'Yogaprabhava', the drug's effectiveness, and progressive immunity with diet and lifestyle can be more easily studied.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase III Clinical Studies on Traditional CAM Therapy in the Treatment of HIV/AIDS|
- Efficacy [ Time Frame: Number of Participants with Adverse Events by weeks 24 ] [ Designated as safety issue: No ]Number of participants with adverse events for efficacy by mentioned time frame will be assessed.
- Viral Load Assay [ Time Frame: Three months follow up ] [ Designated as safety issue: No ]
- Absolute Immune Cells Count Assay(CD3, CD4, and CD8 + T cells) [ Time Frame: Three months follow up study ] [ Designated as safety issue: No ]
- Prolonged Viral Suppression [ Time Frame: Six Month's Follow up study ] [ Designated as safety issue: No ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
"Kallunk oxide (Immunotherapy)"
The participants will be received a daily regimen of "Kallunk oxide(Immunotherapy)" .
Drug: "Kallunk oxide (Immunotherapy) "
The study will be assigned Arm 1 above 450 cu/mm^3 baseline CD + T cells. HIV type-1 subjects will receive one drug, a daily regimen of "Kallunk oxide(Immunotherapy) + Long Pepper", that is a combination of a traditional alternative medicine (Complementary and Alternative Medicine CAM) as "Kallunk oxide" and appropriate drug carrier antidote. The drug assigns to 0.200 mg "Kallunk oxide" molecules with 499.800 mg "Antidote"( This antidote was used as a carrier of "Kallunk oxide" molecules), respectively, for children and adults. Dosage: 500 mg for children and adults. This powder form sample size product will be administered once daily dose on 5 days treatment. The Botanical name of the antidote is "Piper Longum".
Other Name: 'Kallide'
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|Contact: Ramakrishnan Madhusoodanan, PHD||04772270926, firstname.lastname@example.org|
|Project Site Office, Near Sivan Kovil, Nallepily, Hospital of Integrated Research Site HIRS [new])||Active, not recruiting|
|Palakkad, Kerala, India, 678553|
|Project Site Office, Hospital of Integrated Research Site HIRS(New), Karoor, Ambalapuzha-PO, Alleppey-District, Kerala, India 688561||Recruiting|
|Alleppey, India, 688561|
|Contact: Ramakrishnan Madhusoodanan, PHD 9387926565 email@example.com|
|Principal Investigator: Ramakrishnan Madhusoodanan, PHD|
|Project Site Office, Hospital of Integrated Research Site HIRS(New), Ahammed Nagar, Mathura Nagar, Bhingar- PO||Recruiting|
|Mumbai, India, 414002|
|Contact: Ramakrishnan Madhusoodanan, PHD 0091 9387926565 firstname.lastname@example.org|
|Principal Investigator: Ramakrishnan Madhusoodanan|
|Principal Investigator:||Ramakrishnan Madhusoodanan, PHD||Traditional Alternative Medicine Research Center|