Traditional Complementary and Alternative Medicine (CAM) Therapy in the Treatment of HIV/AIDS
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|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|
|Actual Primary Completion Date :||February 27, 2017|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|