HIV Infections Clinical Trial
Official title:
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 and the CD45+. 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 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.
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