Clinical trial NCT00276991: Traditional CAM Therapy in the Treatment of HIV/AIDS
Official title: Modest Phase 1 and Phase II Clinical Studies on Traditional CAM Therapy in the Treatment of HIV/AIDS
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: HIV Infections
Keywords: Prolonged Viral Suppression
HIV Infections
Lead sponsor: Traditional Alternative Medicine Research, India
Sponsor class: OTHER
First posted: 2006-01-13
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: SafeDose,
timeFrame: Six months follow up
Secondary outcomes:
measure: Viral Load Assay
timeFrame: Three months follow up
measure: Absolute Immune Cells Count Assay(CD3, CD4, and CD8 + T cells)
timeFrame: Three months follow up in Phase - II study
measure: Prolonged Viral Suppression
timeFrame: Six Month's Follow up study( In Phase-II Study)
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Project Site Office, Hospital of Integrated Research Site HIRS(New), Ahammed Nagar, Mathura Nagar, Bhingar- PO
Study officials:
affiliation: Traditional Alternative Medicine Research Center
name: Ramakrishnan Madhusoodanan, PHD
role: PRINCIPAL_INVESTIGATOR
References: