Traditional Complementary and Alternative Medicine (CAM) Therapy in the Treatment of HIV/AIDS
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

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.
    

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 booster dose Kallunk Oxide
      molecules 5 mg to all participants,especially, greater than 8 years old children (Adolescence
      and Adults) , 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 cure will follow- up. The study will be
      investigated the T- Lymphocytes (immune) response to HIV. The impact of the CD3+, CD4+,CD8 T
      cells and CD45+ 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 individually being noted.

      During this treatment period, in case, any of the patients have temperature, digestion
      complaint or chill, etc. may vary. Only 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:

      5 mg "Kallunk Oxide (Immunotherapy)" molecules with the antidote 1995 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 Kallunk Oxide (5
      mg) and "Long Pepper" (1995 mg) in ART drug ( one tablet contains Zidovudine, lamivudine, and
      nevirapine ) using adults (<45) and adolescence (the ages12 to 18 years female and 14 to 18
      years old male) to access serum negative status of HIV in CD+ T cell number <350 cu/mm^3 of
      ART using HIV-patients..

      Favorable results on integrative intervention approach is point out that before using
      "Kallunk Oxide (Immunotherapy)' with ART is need nearly a six hour time frame. More
      meaningfully, it is stated that the HIV/AIDS patient may use ART at the evening time to avoid
      possible side effects as joint pain and fatigue (which are seldom cases).

      The booster dose regimen of this therapy is administered as once daily dose for 10 days
      adherence for six months ART drug (Not Kallunk Oxide Therapy) tolerance. If the virus is not
      suppressed completely, drug resistance can develop. So, through this study the serum negative
      status of HIV from baseline to 24 weeks will be followed-up.

      Dosage: powder form sample size product 2 gm (Kallunk Oxide + Antidote) for children and
      adults as once daily dose and is recommended to 7 days daily regimen for 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, cow 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 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.
    

Intervention name(s): "Kallunk oxide (Immunotherapy) "
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): 'Kallide'
Intervention MeSH terms: Immunomodulating Agents
Intervention model: Single Group Assignment
Intervention model description: Open Label
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prolonged Viral Suppression; HIV Infections