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Traditional CAM Therapy in the Treatment of HIV/AIDS

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ClinicalTrials.gov Identifier: NCT00276991
Recruitment Status : Terminated (Lack of funding prevented the recruitment of 1000 HIV Patients all over India)
First Posted : January 13, 2006
Last Update Posted : November 4, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
HIV Infections Drug: "Kallunk oxide (Immunotherapy) " Phase 1 Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2007
Primary Completion Date : October 2009
Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
"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'


Outcome Measures

Primary Outcome Measures :
  1. SafeDose, [ Time Frame: Six months follow up ]

Secondary Outcome Measures :
  1. Viral Load Assay [ Time Frame: Three months follow up ]
  2. Absolute Immune Cells Count Assay(CD3, CD4, and CD8 + T cells) [ Time Frame: Three months follow up in Phase - II study ]
  3. Prolonged Viral Suppression [ Time Frame: Six Month's Follow up study( In Phase-II Study) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: November 4, 2015
Last Verified: November 2015

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

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