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Traditional Complementary and Alternative Medicine (CAM) Therapy in the Treatment of HIV/AIDS

This study is currently recruiting participants.
Verified April 2013 by Traditional Alternative Medicine Research, India
Sponsor:
Information provided by (Responsible Party):
RAMAKRISHNAN MADHUSOODANAN, Traditional Alternative Medicine Research, India
ClinicalTrials.gov Identifier:
NCT01349062
First received: May 3, 2011
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
  Purpose

This research work is important for the cure/control of HIV infection. The study is intended to confirm the efficacy of "Kallunk Oxide (Immunotherapy)" molecules in the Treatment of HIV infection. The study will investigate the T- Lymphocytes (immune) response to HIV in order to boost the body's natural immune ability against infection. The basic study is directly inhibit a protein's increased functions, not only in the CD4+T cell but also CD3+ and CD8+ T cells.

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 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III 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:
  • Efficacy [ Time Frame: Number of Participants with Adverse Events by weeks 24 ] [ Designated as safety issue: No ]
    Number of participants with adverse events for efficacy by mentioned time frame will be assessed.


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 study ] [ Designated as safety issue: No ]
  • Prolonged Viral Suppression [ Time Frame: Six Month's Follow up study ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: March 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
"Kallunk oxide (Immunotherapy)"
The participants will be received a daily regimen of "Kallunk oxide(Immunotherapy)" .
 Drug: "Kallunk oxide (Immunotherapy) "
The study will be assigned Arm 1 above 450 cu/mm^3 baseline CD + T cells. HIV type-1 subjects will receive 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 0.200 mg "Kallunk oxide" molecules with 499.800 mg "Antidote"( This antidote was used as a carrier of "Kallunk oxide" molecules), respectively, for children and adults. Dosage: 500 mg for children and adults. This powder form sample size product will be 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 45 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 18 years of age
  • Interest to use of study drugs
  • Follow at a participating clinical site and
  • Children 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: NCT01349062

Contacts
Contact: Ramakrishnan Madhusoodanan, PHD 04772270926, 9387926565 tamrc_in_org@yahoo.co.in

Locations
India
Project Site Office, Near Sivan Kovil, Nallepily, Hospital of Integrated Research Site HIRS [new]) Active, not recruiting
Palakkad, Kerala, India, 678553
Project Site Office, Hospital of Integrated Research Site HIRS(New), Karoor, Ambalapuzha-PO, Alleppey-District, Kerala, India 688561 Recruiting
Alleppey, India, 688561
Contact: Ramakrishnan Madhusoodanan, PHD     9387926565     tamrc_in_org@yahoo.co.in    
Principal Investigator: Ramakrishnan Madhusoodanan, PHD            
Project Site Office, Hospital of Integrated Research Site HIRS(New), Ahammed Nagar, Mathura Nagar, Bhingar- PO Recruiting
Mumbai, India, 414002
Contact: Ramakrishnan Madhusoodanan, PHD     0091 9387926565     madhusoodanan_ramakrishnan@yahoo.com    
Principal Investigator: Ramakrishnan Madhusoodanan            
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: NCT01349062     History of Changes
Other Study ID Numbers: 00276991
Study First Received: May 3, 2011
Last Updated: April 25, 2013
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 May 16, 2013