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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 27, 2014
Last verified: June 2014
  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:


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 2015
Estimated Primary Completion Date: February 2015 (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'

  Hide Detailed Description

Detailed Description:

This research study is an individual investigator initiated meritorious project to confirm the efficacy of "Kallunk Oxide (Immunotherapy)" in the treatment of HIV- infection.The Previous clinical studies are showing that the T- Lymphocytes responses to "Kallunk Oxide (Immunotherapy)" is effective in the treatment of HIV- infection.

This randomized intervention study to confirm the efficacy of optimum dose 0.200 mg to all participants,especially, greater than 8 years old children, men and women. The Principal Investigator will be selected the informed consented patients to recruit for this trial. This study will be adhered by "Helsinki Declaration".

The patient's assays of Lymphocyte Enumeration is the primary end point. Immune output of this drug and it's progressive immunity against HIV will follow- up. The study will be investigated the T- Lymphocytes (immune) response to HIV. The impact of the CD3+, CD4+, and CD8+ T cells response to "Kallunk Oxide (Immunotherapy)" will be studied.

Patient's body weight, CD4+ T cells and other hematological status will be investigated before and after the treatment period.

The research team is also mindful the symptoms such as nausea, fatigue and weight loss, sweating, shortness of breath, joint pain, etc. will be individually being noted.

During this treatment period, in case, any of the patients have temperature, digestion complaint or chill, etc. may vary. In this circumstance,the patients not advised to use the controlled diet protocol or use of mutton soup, milk and cow ghee.

Privacy and Confidentiality:

The study must be handled a transparent privacy environment to recruit HIV-infected people all over India and the data will be confidentially protected with Genuine written informed consent.

Dosage:

0.200 mg "Kallunk Oxide (Immunotherapy)" molecules with the antidote 499.800 mg "Long Pepper"(Botanical name- Piper longum) for > 8 to < 45 years old children and adults from both genders.The study will also be evaluated the effectiveness of booster dose(4999.800 mg) "Long Pepper".

Dosage: powder form sample size product 500 mg for children and adults as once daily dose and will be recommended to 5 days daily regimen and monthly use as mentioned baseline and six (6) months time frame.

Controlled Nourished diet:

Patients will be controlled by nourished diet protocol. Eat wheat products, rice food products, milk (only ½ cup), cow ghee, green gram,banana, mutton soup,sweet fruits as apple, orange and prepared black pepper added vegetable foods.

Restriction:

Salts, other oils, mustard,Pumpkin,lemon juice, and tamarind fish items are not use within 10 days of medication.

Drug Administration:

In this study, patients can use the capsule/powder form medicine with 1/2 cup hotter water. HIV- patients will be used one drug "Kallunk oxide (Immunotherapy)" as calcined/or oxidized molecules.

Precaution:

No precaution is needed. The patients can avoid sediments at the bottom of the cup.

  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
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

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: June 27, 2014
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 July 23, 2014