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

• 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.
  
  

• 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 ]
  

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 investigate 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 will be handled a transparent privacy environment to recruit HIV-infected people all over India and the data will be confidentially protected with 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 use and monthly use as mentioned baseline and 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.