Indian Journal of Science and Technology Vol. 4 No. 12 (Dec 2011) ISSN: 0974- 6846

Indian Journal of Science and Technology Vol. 4 No. 12 (Dec 2011) ISSN: 0974- 6846
Research communication ¡§Traditional way of treating HIV¡¨ R.Madhusoodanan
„¦Indian Society for Education and Environment (iSee) http://www.indjst.org Indian J.Sci.Technol.
1687
Traditional antidotes ¡§Kallunk oxide¡¨ in the treatment of HIV/AIDS
Ramakrishnan Madhusoodanan
Traditional Alternative Medicine Research Center TAMRC-INDIA, IPF Code: 10001796, Velumparambil House,
Kakkazhom-PO, Alleppey, Kerala-688005, India
tamrc_in_org@yahoo.co.in
Abstract
Immune deficiency is an important problem on HIV/AIDS patients. Traditional antidotes ¡§Kallunk oxide¡¨, a
Complementary and Alternative Medicine (CAM), could be better restored the immunity in initial stage of HIV type-1
patients. The performed modest phase-1 study was observational, prospective and designs as open label, case- only,
randomized, treatment, and efficacy research enrolled with CD3+ and CD4+ T cell counts >450, >250 and <200
cu/mm3 of 20 HIV/AIDS patients between the ages 8 and 55 years from both genders at the Project Site Office, HIRS,
Palakkad- Dt, Kerala, India. The participants were received traditional antidotes ¡§Kallunk oxide¡¨ treatment and the study
includes Lymphocyte cell counts as assessed by Flow fluorescence cytometry analysis. The absolute CD3+ and CD4+
T cell numbers increased in four (4) HIV type-1 patients, as confirmed by the baseline CD4+ T cell counts above 450
cu/mm3, showing above 50% increase after the CAM therapy. This traditional antidotes ¡§Kallunk oxide¡¨ treatment
boosts initial stage of HIV type-1 patients¡¦ immunity.
Keywords: AIDS, Antidote, Kallunk oxide, HIV treatment, Siddha therapy, Traditional Indian Medicine.
Introduction
World Health Organization (WHO) had established
that, in developing countries culturally-acceptable
traditional medicine shows excellent outcomes in
HIV/AIDS treatment (Cachay ER, 2011). The U.S.
government¡¦s agency, the National Institutes of Health
(NIH) had commented in their Funding Opportunity
Description that, in many developing countries traditional
medicine playing a central role in available and
accessible care and prevention strategies, although little
research has focused on this important aspect to wipe out
the HIV infection (Simone et al., 2007).
¡§Kallunk oxide¡¨ is an ancient treatment relates to
Traditional Indian Siddha Medicine (Fritts et al., 2008),
which has been handed down by tradition. Siddha
medicine (Gogtay et al., 2002) is common among the
Tamil people in south of India, and similar to Ayurveda
except that it is employed more minerals and metals in its
therapies. There are 32 internal and 32 external
medicines are included in this ancient system of
medicine. Among the 32 internal medicines, this study
was selected the top most rejuvenate medicine as
¡§Kallunk oxide¡¨ treatment to cure/control of HIV (Ramjee
et al., 2007) infection. In Siddha texts, ¡§Kallunk¡¨ is defined
as an alloyed form of metals and pashanams
(consolidated minerals, especially, those could not resist
the action of fire) by using secret methods. It is
traditionally incinerated by burning cow dung cakes. The
end product from this repeated process is reddish color
powder as oxide form molecules. It is one of the special
features of Siddha medicine and is not known to other
medical systems in India or other countries. The
preparation of Kallunk oxide relates to some of the
alchemical process leading to rejuvenating treatment
named Kaya Kalpa by Siddha concept. It is considered as
unique healing agent believes to effective therapy in
treating chronic as well as infectious diseases.
This research, Phase-I (Smita et al., 2006) study, was
individual investigator initiated project to identify the
safety and efficacy (Wilson et al., 2007) of
Complementary and Alternative Medicine (CAM) in the
treatment of HIV infection. The 20 enrolled Phase-I study
participants were initial and chronic groups infected with
Human Immune deficiency Virus (Malhotra et al., 2007)
HIV type-1. Study aims therapy¡¦s potential Inhibition of
highly productive HIV-1 infection in T cells (Paskaleva et
al., 2006) by traditional antidotes ¡§Kallunk oxide¡¨
molecules.
Materials and methods
In this modest Phase-I clinical trial, the Principal
Investigator recruits only informed consented HIV/AIDS
patients. The full oral information about this study as well
as the detailed inclusion criteria, as established in the
protocol register www.clinicaltrials.gov, was given to the
patients and clearly described about antidotes ¡§Kallunk
oxide¡¨, a traditionally using alternative Siddha medicine in
India. Conducted study was Observational (Preeyaporn
Srasuebkul et al., 2007) and patients Case-Only. In this
prospective study, the number of groups/ cohorts was
taken into two Arms and 20 HIV/AIDS patients were
participated in this study.
The study recruited CD3+ and CD4+ T cell count
>450 and >250 cu/mm3 of HIV- infected persons in Wing
No.1 group and <200 cu/mm3 of AIDS patients in Wing
No.2 group at the Project Site Office, Palakkad - Dt,
Kerala, in India. The CD4+ T cells >50, >250, and >450
cu/mm3 were baseline counts and the ages enrolled
between 8 and 55 years from both genders (Gupta et al.,
2007).
Study had met the inclusion criteria such as: Patients
have HIV ¡V infection, Able and willing to use the study
Indian Journal of Science and Technology Vol. 4 No. 12 (Dec 2011) ISSN: 0974- 6846
Research communication ¡§Traditional way of treating HIV¡¨ R.Madhusoodanan
„¦Indian Society for Education and Environment (iSee) http://www.indjst.org Indian J.Sci.Technol.
1688
drug, at clinical trial participation, and greater than 8 years
old children.
The study had met the predefined exclusion criteria
were; medical side effects, pregnant or breast feeding,
history of significant cardiac abnormalities or
dysfunctions, using antiretroviral therapy drugs, receiving
certain drugs or treatments, unable to be followed at a
participating clinical site, children of any age less than 8
years old, any serious conditions like severe chronic
stage AIDS cases, allergy to any of the study drugs or
their formulations, tobacco, alcohol and drug addicting
patients.
The drug was traditionally prepared as oral powder
therapy, respectively, 100 and 200 mg antidote combines
with 0.01 and 0.04 mg highly purified and calcined
molecules of ¡§Kallunk oxide¡¨. The minimum dose of
tolerance had taken as 100.01 mg and 200.04 mg
antidotes ¡§Kallunk oxide¡¨ molecules, was added to 1/2
cup hot water. This combination therapy (Fiscus et al.,
2007) was used once daily dose in five days, as one
course, and was continued the second course after 15
days of therapy interval.
The medicine 100.01 mg was given for one child in
Wing No.1 group while, rest of 19 HIV- infected adults in
Wing No.1 & 2 groups received 200.04 mg. All patients
were treated by two course medicine during the period of
5 to 25 days and taken six months to one year follow -up
study.
This research study adhered with Helsinki Declaration
and conducted from November 2006 to October 2007.
This study has been reviewed and approved by the
Institutional Review Board IRB00004979, TAMRC-Bio-
Medical IRB#1, Approval Number: TAM-IRB-05, and was
sponsored by Traditional Alternative Medicine Research,
India.
Patients received Siddha therapy in two different
times. Safe dose and efficacy of therapy (Manosuthi et al.,
2007) were the outcome measures and this time frame
was taken a follow - up of six months. No safety issues
were designated with these two outcome measures. The
patients were not used injection drug and highly active
antiretroviral therapy (Morris et al., 2007) Viral Load
assay and Cure of opportunistic infections were not
carried out by the poor HIV/AIDS Indian people and the
resources of this Phase-I studies. ELISA and Western
Blot blood tests were used to confirm HIV infection.
Laboratory method
Flow fluorescence Cytometry (Thakar et al., 2006)
assay for CD3+ and CD4+ T cell counts, the total
lymphocyte counts (Moore et al., 2007), observed values,
and reference ranges were assessed by Flow
fluorescence cytometry analysis. Laboratory
investigations along with other relevant clinical
examinations were achieved for final diagnosis with the
quality (Mutimura et al., 2007) of the sample as well as
the assay procedures used.
Results
Statistically, the higher CD3+ and CD4+ T cell counts
were found in four (4) HIV patients after this potent anti
HIV treatment. The enrolled baseline CD4+ T cell counts
>450 cu/mm3 of four (4) HIV patient's CD3+ and CD4+ T
cell counts were highly increased after two courses of
CAM therapy. The patient¡¦s body mass approximately
gained 2 to 5 kg and the AIDS patient¡¦s appetite and
energy also increased. The absolute CD3+ and CD4+ T
cell counts were most commonly monitored.
Hematological and non-hematological toxicities, as
thrombocytopenia, neutrophilia, neutropenia,
eosinopenia, lymphocytosis, nausea, fatigue, vomiting
and yellow skin color were not found. The Wing No.1 & 2
study group's blood data were analyzed and determined
the efficacy of 200.04 mg ¡§Kallunk oxide¡¨ dose. Clinical
Trials Registration ID: NCT00276991, Registry: www.
Clinicaltrials.gov and URL: http:// clinicaltrials.gov.
Discussion
The enrolled 20 patients received this traditional
antidotes ¡§Kallunk oxide¡¨ treatment. The recruitment was
executed by media advertisement and the enrolled
participants were selected from Palakkad- District, Kerala
state, India. The participants were outpatients followed six
(6) site visits after treatment. The patients received this
therapy at the project site. The dosage was administered
as 100.01 mg and 200.04 mg. The study enrolled 10 male
and 10 female HIV/AIDS (Kumar et al., 2006) patients.
The study was carried out one test method and
equipment to ensure the T- Lymphocyte enumeration.
The variations on study results from different laboratories
were minimized the error as 20% to 30%. Patients with
the baseline CD3+ and CD4+ T cell counts >450 cu/mm3
were randomized.
Patients received Siddha therapy in two different
times. Safe dose and its effectiveness were the outcome
measures and this time frame was taken a follow - up of
six months. No safety issues were designated with these
two outcome measures. Viral Load assay and Cure of
opportunistic infections were not carried out by the poor
HIV/AIDS Indian people with resource-limitation (David M
Moore et al., 2007) settings of this Phase-I studies.
Four HIV patients responded to the therapy well. A 29
years old female whose previous absolute CD3+ T cell
counts were noted as 1748 cu/mm3 and her total CD4+ T
lymphocyte counts were evaluated as 580 cu/mm3. After
therapy, the enrolled CD3+ T cell counts increased to
2253 cu/mm3 and the CD4+ T cell counts changed to 663
cu/mm3.
HIV- infected 8 years old female child whose previous
CD3+ T cell counts were noted as 2917 cu/mm3 and
CD4+ T cell counts were 607 cu/mm3. After two courses
of medicine, her CD3+ T cell counts increased to 3032
cu/mm3 and the CD4+ T cell counts to 1304 cu/mm3.
HIV infected woman (34 years old) (Jeannie S Huang
et al., 2006), whose CD3+ T cell counts were 1321
cu/mm3 and CD4+ T cell counts 635cu/mm3. After the
Indian Journal of Science and Technology Vol. 4 No. 12 (Dec 2011) ISSN: 0974- 6846
Research communication ¡§Traditional way of treating HIV¡¨ R.Madhusoodanan
„¦Indian Society for Education and Environment (iSee) http://www.indjst.org Indian J.Sci.Technol.
1689
medicinal therapy, the CD3+ T cell counts changed to
2865 cu/mm3 and the CD4+ T cell counts increased to
868 cu/mm3.
A 38 years old adult whose absolute CD3+ and CD4+
T cell counts were noted as 2049, and 756 cu/mm3,
respectively, and after this treatment, the CD3+ T cell
counts increased to 2420 cu/mm3, and the CD4+ T cell
counts to 963 cu/mm3.
The study found a slow immune response to
antidotes ¡§Kallunk oxide¡¨ occurred in <50 cu/mm3 of
CD4+ T cell counted AIDS patient (Vidal et al., 2007) and
the study confirmed the efficacy of 100.01mg and 200.04
mg minimum doses of this treatment. The study observed
that, the initial stage HIV- infected patients rapidly
responded to antidotes ¡§Kallunk oxide¡¨ than the AIDS
patients.
The administration of treatment, dosage, and dose of
frequency were limited. The given minimum doses were
being first activated in the peripheral blood than lymph
nodes and tissues. The background of the dormant stage
virus and its replicating activities were being stimulated in
HIV- positive patients in order to block the full
immunological benefits. Further more efficient research
study is needed.
Before this treatment, the Median of 20 participant¡¦s
absolute CD4+T cell counts were noted as 306.05
cu/mm3 and after treatment, the CD4+T cell counts
observed as 352 cu/mm3. The difference on median
CD4+ T cell counts was found at 45.95%.
Before this therapy, 20 patients median absolute
CD3+ T cell counts were noted 1285.05cu/mm3. After
treatment, the CD3+ T cell counts were observed at
2336.05cu/mm3. The difference on median CD3+ T cell
counts was determined at 1051 cu/mm3.
In addition, in five patients previous absolute CD4 +T
cell counts (Thakar et al., 2006) below 350 cu/mm3 or less
and their CD3+ T cell counts increased by six month¡¦s
study period. A 38 years old adult patient¡¦s CD4+ T cell
counts increased at 963 cu/mm3 and, especially, CD4
percentage (Yasmin Pirzada et al., 2006) was noted
26.67cu/mm3. The absolute CD3 and CD4 T cells were
substantially improved in sixteen (16) HIV/AIDS patients
at 86% and 45.05%.
Baseline Study
„h Most enrolled patient¡¦s HIV positive (Ramjee et al.,
2007) background was above 4 years
„h All participants received Oral powder form medicine
„h No known toxicity (skin rash, heaptotoxicity, hepatitisrelated
symptom etc) associated with traditional
antidotes ¡§kallunk oxide¡¨.
„h All patients not strictly adhered the controlled diet
protocol.
„h Short- term toxicities were not encountered.
„h All patients had received this therapy 10 minutes
before sunrise.
„h Enrolled participants had no HIV-associated
(Lichtenstein et al., 2007) opportunistic illnesses
(Patrick S. Sullivan et al, 2007).
„h All patients had accessed overall clinical benefit from
this study.
Conclusion
The study evaluated the traditional antidote ¡§Kallunk
oxide¡¨, a Complementary and Alternative Medicine
(Goldrosen, 2004) and its treatment boosted the immunity
in 4 (four) initial stage HIV type-1 patients with the
baseline CD4 + T cell counts >450 cu/mm3.
Acknowledgments
¡§This publication was made possible by grant number
1R01AT002873-01 from the National Center for
Complimentary and Alternative Medicine (NCCAM) at the
National Institutes of Health. Its contents are solely the
responsibility of the authors and do not necessarily
represent the official views of NCCAM.¡¨Authors¡¦
contributions, Author reads and approves this version of
final manuscript, competing interest. Author declares no
competing interests.
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Indian Journal of Science and Technology Vol. 4 No. 12 (Dec 2011) ISSN: 0974- 6846
Research communication ¡§Traditional way of treating HIV¡¨ R.Madhusoodanan
„¦Indian Society for Education and Environment (iSee) http://www.indjst.org Indian J.Sci.