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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 30, 2014
Last verified: September 2014

May 3, 2011
September 30, 2014
March 2012
February 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01349062 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 in Phase - II study ] [ Designated as safety issue: No ]
  • Prolonged Viral Suppression [ Time Frame: Six Month's Follow up study( In Phase-II Study) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

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 0.200mg 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, cow 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 (only sweet), 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.

Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
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'
"Kallunk oxide (Immunotherapy)"
The participants will be received a daily regimen of "Kallunk oxide(Immunotherapy)" .
Intervention: Drug: "Kallunk oxide (Immunotherapy) "
Madhusoodanan R. Traditional Antidotes "Kallunk oxide" in the Treatment of HIV/AIDS. Indian J Sci Technol. 2011 Nov 30;4(12):1687-1690.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
February 2015
February 2015   (final data collection date for primary outcome measure)

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.
Both
8 Years to 45 Years
No
Contact: Ramakrishnan Madhusoodanan, PHD 04772270926, 9387926565 tamrc_in_org@yahoo.co.in
India
 
NCT01349062
00276991
Yes
RAMAKRISHNAN MADHUSOODANAN, Traditional Alternative Medicine Research, India
Traditional Alternative Medicine Research, India
Not Provided
Principal Investigator: Ramakrishnan Madhusoodanan, PHD Traditional Alternative Medicine Research Center
Traditional Alternative Medicine Research, India
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP