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Traditional CAM Therapy in the Treatment of HIV/AIDS

This study has been terminated.
(Lack of funding prevented the recruitment of 1000 HIV Patients all over India)
Sponsor:
Information provided by (Responsible Party):
RAMAKRISHNAN MADHUSOODANAN, Traditional Alternative Medicine Research, India
ClinicalTrials.gov Identifier:
NCT00276991
First received: January 12, 2006
Last updated: October 25, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
HIV Infections
 Drug: "Kallunk oxide (Immunotherapy) "
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Modest Phase 1 and Phase II Clinical Studies on Traditional CAM Therapy in the Treatment of HIV/AIDS

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Traditional Alternative Medicine Research, India:

Primary Outcome Measures:
  • SafeDose, [ Time Frame: Six months follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Viral Load Assay [ Time Frame: Three months follow up ] [ Designated as safety issue: No ]
  • Absolute Immune Cells Count Assay(CD3, CD4, and CD8 + T cells) [ Time Frame: Three months follow up in Phase - II study ] [ Designated as safety issue: No ]
  • Prolonged Viral Suppression [ Time Frame: Six Month's Follow up study( In Phase-II Study) ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: November 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
"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'

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00276991

Locations
India
Project Site Office, Hospital of Integrated Research Site HIRS(New), Ahammed Nagar, Mathura Nagar, Bhingar- PO
Mumbai, India, 414002
Sponsors and Collaborators
Traditional Alternative Medicine Research, India
Investigators
Principal Investigator: Ramakrishnan Madhusoodanan, PHD Traditional Alternative Medicine Research Center
  More Information

Publications:

Responsible Party: RAMAKRISHNAN MADHUSOODANAN, Director, Traditional Alternative Medicine Research Center TAMRC-INDIA., Traditional Alternative Medicine Research, India
ClinicalTrials.gov Identifier: NCT00276991     History of Changes
Obsolete Identifiers: NCT00385424, NCT00505193, NCT00554060
Other Study ID Numbers: TAM10
Study First Received: January 12, 2006
Last Updated: October 25, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Traditional Alternative Medicine Research, India:
Prolonged Viral Suppression
HIV Infections

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on June 17, 2013