Phase III Clinical Studies on Traditional CAM Therapy in the Treatment of HIV/AIDS
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 1,000
- Locations
- 3
- Primary Endpoint
- Efficacy
Study Overview
Brief Summary
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.
Detailed Description
This research study is an individual investigator initiated meritorious project to confirm the efficacy of "Kallunk Oxide (Immunotherapy)" in the treatment of HIV- infection.The Previous clinical studies are showing that the T- Lymphocytes responses to "Kallunk Oxide (Immunotherapy)" is effective in the treatment of HIV- infection.
This randomized intervention study to confirm the efficacy of booster dose Kallunk Oxide molecules 5 mg to all participants,especially, greater than 8 years old children (Adolescence and Adults) , men and women. The Principal Investigator will be selected the informed consented patients to recruit for this trial. This study will be adhered by "Helsinki Declaration".
The patient's assays of Lymphocyte enumeration is the primary end point. Immune output of this drug and it's progressive immunity against HIV cure will follow- up. The study will be investigated the T- Lymphocytes (immune) response to HIV. The impact of the CD3+, CD4+,CD8 T cells and CD45+ response to "Kallunk Oxide (Immunotherapy)" will be studied.
Patient's body weight, CD4+ T cells and other hematological status will be investigated before and after the treatment period.
The research team is also mindful the symptoms such as nausea, fatigue and weight loss, sweating, shortness of breath, joint pain, etc. will individually being noted.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 45 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
"Kallunk oxide (Immunotherapy)"
The participants will be received a daily regimen of "Kallunk oxide(Immunotherapy)" .
Intervention: "Kallunk oxide (Immunotherapy) " (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Viral Load Assay(Three months follow up)
- Absolute Immune Cells Count Assay(CD3, CD4, and CD8 + T cells)(Three months follow up study)
- Prolonged Viral Suppression(Six Month's Follow up study)
Investigators
RAMAKRISHNAN MADHUSOODANAN
Director, Traditional Alternative Medicine Research Center TAMRC-INDIA
Traditional Alternative Medicine Research, India