Traditional Complementary and Alternative Medicine (CAM) Therapy in the Treatment of HIV/AIDS
Phase III Clinical Studies on Traditional CAM Therapy in the Treatment of HIV/AIDS
1 other identifier
interventional
1,000
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hiv-infections
Started Feb 2012
Typical duration for phase_3 hiv-infections
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2011
CompletedFirst Posted
Study publicly available on registry
May 6, 2011
CompletedStudy Start
First participant enrolled
February 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2017
CompletedMarch 3, 2017
March 1, 2017
5 years
May 3, 2011
March 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy
Number of participants with adverse events for efficacy by mentioned time frame will be assessed.
Number of Participants with Adverse Events by weeks 24
Secondary Outcomes (3)
Viral Load Assay
Three months follow up
Absolute Immune Cells Count Assay(CD3, CD4, and CD8 + T cells)
Three months follow up study
Prolonged Viral Suppression
Six Month's Follow up study
Study Arms (1)
"Kallunk oxide (Immunotherapy)"
OTHERThe participants will be received a daily regimen of "Kallunk oxide(Immunotherapy)" .
Interventions
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".
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Project Site Office, Near Sivan Kovil, Nallepily, Hospital of Integrated Research Site HIRS [new])
Palakkad, Kerala, 678553, India
Project Site Office, Hospital of Integrated Research Site HIRS(New), Karoor, Ambalapuzha-PO, Alleppey-District, Kerala, India 688561
Alappuzha, 688561, India
Project Site Office, Hospital of Integrated Research Site HIRS(New), Ahammed Nagar, Mathura Nagar, Bhingar- PO
Mumbai, 414002, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ramakrishnan Madhusoodanan, PHD
Traditional Alternative Medicine Research Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Traditional Alternative Medicine Research Center TAMRC-INDIA
Study Record Dates
First Submitted
May 3, 2011
First Posted
May 6, 2011
Study Start
February 27, 2012
Primary Completion
February 27, 2017
Study Completion
February 27, 2017
Last Updated
March 3, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share