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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
RAMAKRISHNAN MADHUSOODANAN, Traditional Alternative Medicine Research, India
ClinicalTrials.gov Identifier:
NCT01349062
First received: May 3, 2011
Last updated: March 1, 2017
Last verified: March 2017
  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 and the CD45+. 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: Intervention Model: Single Group Assignment
Intervention Model Description:
Open Label
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase III Clinical Studies on Traditional CAM Therapy in the Treatment of HIV/AIDS

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Efficacy [ Time Frame: Number of Participants with Adverse Events by weeks 24 ]
    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 ]
  • Absolute Immune Cells Count Assay(CD3, CD4, and CD8 + T cells) [ Time Frame: Three months follow up study ]
  • Prolonged Viral Suppression [ Time Frame: Six Month's Follow up study ]

Enrollment: 1000
Actual Study Start Date: February 27, 2012
Study Completion Date: February 27, 2017
Primary Completion Date: February 27, 2017 (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 is 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 5 mg "Kallunk oxide" molecules with1995 mg "Antidote"( This antidote was used as a carrier of "Kallunk oxide" molecules), respectively, for children and adults. Dosage: 2000 mg for children and adults. This powder form sample size product will be administered once daily dose on 7 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   (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 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
  • Received certain drugs (Steroid) 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01349062

Locations
India
Project Site Office, Near Sivan Kovil, Nallepily, Hospital of Integrated Research Site HIRS [new])
Palakkad, Kerala, India, 678553
Project Site Office, Hospital of Integrated Research Site HIRS(New), Karoor, Ambalapuzha-PO, Alleppey-District, Kerala, India 688561
Alleppey, India, 688561
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: NCT01349062     History of Changes
Other Study ID Numbers: 00276991
Study First Received: May 3, 2011
Last Updated: March 1, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

ClinicalTrials.gov processed this record on June 27, 2017