Traditional CAM Therapy in the Treatment of HIV/AIDS
Information source: Traditional Alternative Medicine Research, India
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: "Kallunk oxide (Immunotherapy) " (Drug)
Phase: Phase 1/Phase 2
Status: Terminated
Sponsored by: Traditional Alternative Medicine Research, India Official(s) and/or principal investigator(s): Ramakrishnan Madhusoodanan, PHD, Principal Investigator, Affiliation: Traditional Alternative Medicine Research Center
Summary
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.
Clinical Details
Official title: Modest Phase 1 and Phase II Clinical Studies on Traditional CAM Therapy in the Treatment of HIV/AIDS
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: SafeDose,
Secondary outcome: Viral Load AssayAbsolute Immune Cells Count Assay(CD3, CD4, and CD8 + T cells) Prolonged Viral Suppression
Detailed description:
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.
The patients safe and effective optimum dose was the primary out come measure and the Viral
Load assay and Immune Cells Count assay were the secondary outcome measure.
The randomized numbers were arranged with single patient's clinical records. Patient's body
weight, CD4 T cells count, skin thickness, body measurements, blood pressure, temperature,
pulse rates, anti body count, and other hematological examinations were investigated before
and after the treatment period.
The well-designed research team minds the symptoms such as nausea, fatigue,weight loss,
sweating, shortness of breath, joint pain etc and the Side effects of this treatment, if
any, could be carefully noted. On entry and at the end of this study, the biochemical
investigations such as urine examination, serum lipoprotein and cholesterol were
individually noted.
Patient's temperature, digestion complaints, or chill, etc could treated by medicine and
restricted diets without using mutton soup, milk, and cow ghee. The study was reduced
patient's stress as well as depression and also managed the productivity, emotional well
being, immunity and quality of life by the practice of this treatment.
The study was handled a transparent privacy environment to recruit HIV-infected people in
India.
Dosage:
HIV patients were administered with once daily dose of sample size product, 500 mg for
adults and 200 mg for children (up to 8 years old), as one course.
Controlled Nourished diet:
All patients were adhered with nourished diet protocol. The controlled diets were milk (only
1/2 cup), rice and wheat food products, cow ghee, green gram, mutton soup, and prepared
black pepper added vegetable foods.
Restriction:
HIV-Patients were not used salts, other oils, mustard, and tamarind fish items within 10
days of this medication use.
Drug Administration:
HIV- patients were used one drug "Kallunk oxide (Immunotherapy)" as calcined/or oxidized
molecules. The powder form sample size medicine was put into 1/2 cup hotter water (an
adjuvant).
Precaution:
No precautions be needed. Patients were not used sediments at the bottom of the cup.
Eligibility
Minimum age: 8 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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 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)
Exclusion Criteria:
- 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.
Locations and Contacts
Project Site Office, Hospital of Integrated Research Site HIRS(New), Ahammed Nagar, Mathura Nagar, Bhingar- PO, Mumbai 414002, India
Additional Information
Starting date: November 2007
Last updated: October 25, 2012
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