Modest Phase 1 and Phase II Clinical Studies on Traditional CAM Therapy in the Treatment of HIV/AIDS
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- SafeDose,
研究概览
简要总结
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.
详细描述
This research was individual investigator initiated meritorious project to identify potential roles for the safe and effective use of Complementary and Alternative Medicine CAM in the treatment of HIV infection.
This modest Phase-I and phase II clinical trials were intervention Studies. In the case of HIV infections, these studies were formulated each 20 random numbered batch. The Principal Investigator (PI) selects the informed consented patients and the recruited study was adhered by Helsinki Declaration.
Selection of subjects: HIV patients with CD3, CD4, and CD8 + T cell counts >450 cu/mm^3 were enrolled in Wing No: 1 group. HIV patients with CD+ T cell counts >450 cu/mm^3 were recruited for basic Arm study. The selected Arm - 1 of this research, the specific and potential milestone on baseline CD+T cell counts >450 cu/mm^3 was determined from the outcomes of previously conducted Observational Phase-1 study data.
The statistical evaluation laboratory on parameters in exists group was measured through Immune Cells Count Assay. The prolonged viral suppression and reversal of HIV seropositivity were the ultimate research outcomes and this study was evaluated the safety and efficacy of this drug. Absolute assays of Viral Load, Lymphocyte Enumeration, Western Blot blood test and convinced mean values and reference range methods were adopted for laboratory study.
The drug was administered as optimal doses 200 mg and 500 mg to study subjects, respectively, between 8 and 17 years old children and 18 and 65 years old Men and Women as anticipated 500 Female and 500 Male participants. The ELISA/P-24 test was used to confirm HIV-seropositivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 21 years of age
- •Interest to use of study drugs
- •Follow at a participating clinical site and
- •Children of any age (greater than 8 years old)
排除标准
- •Medical side effects
- •Pregnant or breast feedings
- •History of significant cardiac abnormalities or dysfunction
- •Anti Retro viral Treatment ART used patients
- •Received certain drugs 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.
研究组 & 干预措施
"Kallunk oxide (Immunotherapy)"
The participants were received a daily regimen of "Kallunk oxide(Immunotherapy)" .
干预措施: "Kallunk oxide (Immunotherapy) " (Drug)
结局指标
主要结局
SafeDose,
时间窗: Six months follow up
次要结局
- Viral Load Assay(Three months follow up)
- Absolute Immune Cells Count Assay(CD3, CD4, and CD8 + T cells)(Three months follow up in Phase - II study)
- Prolonged Viral Suppression(Six Month's Follow up study( In Phase-II Study))
研究者
RAMAKRISHNAN MADHUSOODANAN
Director, Traditional Alternative Medicine Research Center TAMRC-INDIA.
Traditional Alternative Medicine Research, India