Traditional Complementary and Alternative Medicine (CAM) Therapy in the Treatment of HIV/AIDS
|ClinicalTrials.gov Identifier: NCT01349062|
Recruitment Status : Completed
First Posted : May 6, 2011
Last Update Posted : March 3, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: "Kallunk oxide (Immunotherapy) "||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open Label|
|Masking:||None (Open Label)|
|Official Title:||Phase III Clinical Studies on Traditional CAM Therapy in the Treatment of HIV/AIDS|
|Actual Study Start Date :||February 27, 2012|
|Primary Completion Date :||February 27, 2017|
|Study Completion Date :||February 27, 2017|
"Kallunk oxide (Immunotherapy)"
The participants will be received a daily regimen of "Kallunk oxide(Immunotherapy)" .
Drug: "Kallunk oxide (Immunotherapy) "
The study is 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 5 mg "Kallunk oxide" molecules with1995 mg "Antidote"( This antidote was used as a carrier of "Kallunk oxide" molecules), respectively, for children and adults. Dosage: 2000 mg for children and adults. This powder form sample size product will be administered once daily dose on 7 days treatment. The Botanical name of the antidote is "Piper Longum".
Other Name: 'Kallide'
- Efficacy [ Time Frame: Number of Participants with Adverse Events by weeks 24 ]Number of participants with adverse events for efficacy by mentioned time frame will be assessed.
- Viral Load Assay [ Time Frame: Three months follow up ]
- Absolute Immune Cells Count Assay(CD3, CD4, and CD8 + T cells) [ Time Frame: Three months follow up study ]
- Prolonged Viral Suppression [ Time Frame: Six Month's Follow up study ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01349062
|Project Site Office, Near Sivan Kovil, Nallepily, Hospital of Integrated Research Site HIRS [new])|
|Palakkad, Kerala, India, 678553|
|Project Site Office, Hospital of Integrated Research Site HIRS(New), Karoor, Ambalapuzha-PO, Alleppey-District, Kerala, India 688561|
|Alleppey, India, 688561|
|Project Site Office, Hospital of Integrated Research Site HIRS(New), Ahammed Nagar, Mathura Nagar, Bhingar- PO|
|Mumbai, India, 414002|
|Principal Investigator:||Ramakrishnan Madhusoodanan, PHD||Traditional Alternative Medicine Research Center|