Traditional CAM Therapy in the Treatment of HIV/AIDS
|ClinicalTrials.gov Identifier: NCT00276991|
Recruitment Status : Terminated (Lack of funding prevented the recruitment of 1000 HIV Patients all over India)
First Posted : January 13, 2006
Last Update Posted : November 4, 2015
This research work is important for the cure/control of HIV infection. The objectives of a treatment case on HIV patient is essentially to bring down the viral load closer to undetectable level. The studies are depend on the potential influence of 'Kallunk Oxide' on the CD4+ T cells and the effectiveness on surface of HIV-1. The basic study is to break surface protein and directly inhibit a protein's increased functions, not only in the CD4+T cell but also CD3 and CD8+ T cells, by appropriate antidote.
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 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Modest Phase 1 and Phase II Clinical Studies on Traditional CAM Therapy in the Treatment of HIV/AIDS|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
"Kallunk oxide (Immunotherapy)"
The participants were received a daily regimen of "Kallunk oxide(Immunotherapy)" .
Drug: "Kallunk oxide (Immunotherapy) "
The study was assigned only one Arm >450 cu/mm^3 of baseline CD + T cells. HIV type-1 subjects were received 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 0.100 mg and 0.200 mg "Kallunk oxide" molecules with 199.900 mg, and 499.800 mg "Antidote"( This antidote was used as a carrier of "Kallunk oxide" molecules), respectively, for children and adults. Dosage: 200 mg for children and 500 mg for adults. This powder form sample size product was administered once daily dose on 5 days treatment. The Botanical name of the antidote is "Piper Longum".
Other Name: 'Kallide'
- SafeDose, [ Time Frame: Six months follow up ]
- 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 in Phase - II study ]
- Prolonged Viral Suppression [ Time Frame: Six Month's Follow up study( In Phase-II Study) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276991
|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|