development of ayush qol -2 for improvement of quality of

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• AN INSIGHT ON RESEARCH AND DEVELOPMENT IN CCRAS
  WITH SPECIAL FOCUS ON
• DEVELOPMENT OF AYUSH QOL -2 FOR IMPROVEMENT OF
  QUALITY OF LIFE (QOL)IN HIV / AIDS

Dr. G.S.LAVEKAR DIRECTOR CCRAS
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Initiation of Science

• SCIENTIFIC METHODOLOGY OF LEARNING, CLINICAL
  PRACTICE AND RESEARCH IN AYURVEDA
• The process of learning, research and clinical
  practice are scientific and evidence based. Like
  other systems of ancient Indian learning,
  Ayurveda is discovered through most suitable
  sources (Paramanas) viz.
• (1) Pratyaksha (direct perception),
• (2) Anumana (logical inference),
• (3) Aptopadesa (verbal and authentic
• documentary testimony),
• (4) Yukti (experimental evidence) etc. which are
  
• reproducible
• To revitalize these basic concepts, it is pivotal
  to create the measurable objective evidences with
  the aid of modern science and technology.
• This would help for sustainable utilization of
  maximum diagnostic and therapeutic principles of
  these systems and create evidences which are
  reproducible.

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• Emphasis Of Ayurveda On Integration A Key
  issue
• Understands mind-body spirit connection,
  believes in bodys self healing power, involves
  the patients in decision making, reassures about
  positive aspects, sets himself as a role model,
  is honest, truthful dedicated and committed and
  is willing to accept integrated system of medical
  practice.
• Ayurveda emphasizes to adopt knowledge of various
  sciences.

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• Through studying any single branch of science, a
  physician or surgeon never get the complete
  knowledge of Medical Science.
• Therefore he should study as many allied branches
  of science or philosophy as possible.
• Authors of Ayurvedic texts emphasized to study
  all the related sciences which have implicating
  with the medicine i.e. Biology, Chemistry etc.
• They clearly mentioned that one should use the
  additions of the updated technology to enrich
  ones own system and use all the tools
  techniques of the scientific community to make
  their science to go in pace with the present
  world.

5

Central Council for Research in Ayurveda and
Siddha,

• Established in 1978, after the bifurcation of
  erstwhile CCRIMH (1969), is an Apex body in
  India for the Formulation
• Co-ordination
• Development
• Promotion
• of research in Ayurveda and Siddha Systems of
  Medicine on scientific lines.

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10
16
12
Patna
Hastinapur
Pondicherry
New Delhi
Palayamkottai CRU
Chennai
Junagarh
Patiala
ALRCA
Palayamkottai SMPU
Trivandrum
Cheruthuruthy
Kottakal
Chennai
Tarikhet
Mumbai
JamnagarMCR
Pune
Kolkata
JamnagarDSRP
Hyderabad
Lucknow
Itanagar
Leh
Gwalior
Guwahati
Jaipur
Car-NicobarTHCRP
Gangtok
Bhubneshwar
Ahmedabad
Mandi
Jammu
Bangalore
Jhansi
Nagpur
TOTAL38
Vijayawada
Bangalore
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RESEARCH AREAS
RESEARCH AREAS

• Literary Research (Revival and retrieval of rare
  books and manuscripts)
• Fundamental research (Anukta dravyas, Prakriti)
• Drug research
• Clinical Research
• RCH Research
• Neutraceutical Research (Antartica Tea and
  Antartica laddu, food supplement for school going
  children )
• Cosmeceutical Research (AYUSH face pack)
• Bio Medical Instrumentation Research ( Panchkarma
  instruments)

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• SIGNIFICANT LEADS
• Ayush-64 for Malaria
• Ayush-56 for epilepsy
• Ayush-82 for Diabetes mellitus
• 777 Oil for Psoriasis
• Antartica Tea and Antartica laddu
• Ayush Face Pack
• Anti-dandruff, Anti fungal
  Anti-pollutant/Air
• refreshing agent
• Pippalyadi Yoga an oral contraceptive for
  females.

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• DRUG RESEARCH
• (SURVEY ,CULTIVATION ,DRUG STANDARDIZATION ,
• AND PHARMACOLOGICAL STUDIES)
• No. of Raw drugs collected 1767
• No. of Plant Specimens Collected
  1,20,000
• No. of Folk-Claims Collected
  3800
• No. of the Gardens 6
• Area under cultivation (in acres)
  165
• Total No. of species under cultivation 460
• No. of Guggulu plants under cultivation
  15000
• No. of plants included in AFI I
  200
• Pharmacological Studies More than 340 drugs used
  in Ayurveda and Siddha including single drugs,
  compound formulations and coded drugs have been
  investigated in vivo and vitro experimental
  models for routine pharmacological screening as
  well as for specific effects.

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LITERARY RESEARCH

• - Books and Monographs Published gt90
• - Journals of CCRAS
• - Journal of Research in Ayurveda Siddha
• - Bulletin of Medico-Ethno-Botanical Research
• - Bulletin of Indian Institute of History of
  Medicine
• - News letter
• - The Council has published a Database on
  medicinal plants used in Ayurveda ( In Seven
  Volumes)
• From 60 Libraries/Repositories/Museum collected
  994 Manuscripts
•  - Microfilms 272

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NEW DRUG DEVELOPMENT
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CLINICAL TRIALS OF CODED FORMULATION (OF WHICH
STANDARDIZATION, SAFETY AND TOXICITY STUDIES
BIOLOGICAL/TARGETED ACTIVITY STUDIES ARE
COMPLETED) ON SELECTED CLINICAL CONDITIONS.
1. Ayush Rasayan-A and Ayush Rasayan-B for
Improving QOL in elderly persons
2. Ayush-RP for Sickle Cell Anaemia  
3. Ayush-Osto for Osteoporosis   4.
Ayush-Osto for fractures    5. Ayush-LIV
for Hepatitis B C 6. Ayush-M for Migraine
7. Ayush-SL Capsules and Ayush-SL External
application for Morbid cases of
Filariasis   8. Ayush Manas for Mental
retardation    9. Ayush QOL-2 A for improvement
of quality of life in HIV/AIDS 10. Ayush QOL
2-C for improvement of quality of life in cancer

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CLINICAL TRIALS OF SELECTED CODED FORMULATION
(OF WHICH STANDARDIZATION, SAFETY AND
TOXICITY STUDIES BIOLOGICAL/TARGETED ACTIVITY
STUDIES ARE IN PIPE LINE) ON SELECTED CLINICAL
CONDITIONS. 1. Ayush-RCH-2 for Menopausal
syndrome    2 . Ayush-CARD for Chronics stable
Angina (Hridroga)    3. Ayush-UT for
Urolithiasis (Mutrashmari)     4. Ayush-for
DIAB Diabetes (Madhumeha)     5. Ayush-RHU-2
and Erand Taila-oil of Ricinus
communis for Rheumatoid Arthritis (Amavata).
    6. Ayush-RCH-1 and Ayush-RCH-3 for
DUB(Animitta raktapradara)    7. Ayush-BA
for Tamaka Swasa 8. Ayush-VJ-1and
-Ayush-VJ-2 for Malaria (Vishama
jwara)

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IPR PROTECTION AND COMMERCIALIZATION
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COLLABORATIVE RESEARCH
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• Development Of AYUSH QOL-2

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Global Scenario

• The Joint United Nations Program on HIV/AIDS and
  the World Health Organization (As per AIDS
  epidemic update, December 2003-UNAIDS) estimated
  that 34-46 million people are living with
  HIV/AIDS.
• More than 20 million have died from AIDS. 4
  million children have been infected since the
  virus first appeared.
• A report released by UNAIDS concludes that at the
  current rate of infection there would be 45
  million new cases by 2010.

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Indian scenario

• In India HIV/AIDS epidemic is about 20 years old
  and is considered to be the most serious public
  health problem.
• The first HIV infection was reported from Chennai
  (Madras) and first AIDS case from Mumbai (Bombay)
  in 1986.
• The infection has currently taken epidemic
  proportions in the country. NACO estimates that
  5.13 million persons are currently living with
  HIV in India by end of 2004.
• 28 thousand new infections were reported in
  2004. Although there has been some decline in the
  new HIV infections in 2004, yet the situation
  continues to be grim.
• The HIV, which has earlier confined to high risk
  categories, has started percolating down to
  general population with 2 prevalence in Mumbai,
  gt1in Hyderabad, Banglore, Chennai and lt1 in
  Kolkata, Ahmedabad and Delhi. The national
  prevalence percentage, however, is currently
  0.91.

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Indian scenario
Indian states have been divided into 3 groups on
the basis of the prevalence of the disease in the
population Group 1 States of Maharashtra, Tamil
Nadu, Karnataka, Andhra Pradesh, Manipur, Goa
where HIV prevalence in general population gt5
and gt1 in antenatal women. Group 2 States of
Gujarat, Pondicherry where HIV prevalence in
general population is gt5 and in antenatal women
lt1. Group 3 Those states where HIV prevalence
in general population is lt5 and in antenatal
women is lt1.
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Indian scenario

• Worst hit state is Andhra Pradesh with 2.25 of
  its population estimated to be infected
• Rural and urban populations are equally
  vulnerable, with 58.5 of those infected live in
  village.
• 31.32lakh are male among the total number of
  persons infected with HIV,

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Introduction

• In spite of recent advances in the treatment of
  HIV/AIDS, there is no known cure the final
  outcome for every HIV-infected patient is death

• A patient may die as a consequence of his/her
  first HIV manifestation or may develop a
  life-threatening OI and recover if appropriate
  treatment is given on time

• Most patients, however, will experience an
  increasing frequency of health problems and
  finally reach a stage of severe immunosuppression
  over a period of several years

• As the disease progresses, the need for
  symptomatic relief will become more important
  than curative treatment

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ROLE OF AYUSH

• The most prevalent users of Ayurveda /TSM are
  individuals who have incurable,
  nonlife-threatening conditions that may be
  chronic.
• The second largest group of users are those
  struggling with chronic, potentially
  life-threatening diseases, such as cancer and
  HIV-AIDS.
• Both groups turn to Ayurveda /TSM for a variety
  of reasons, such as to improve immune
  functioning, to improve overall functioning, to
  increase quality of life, to cope with side
  effects from conventional therapies, and to
  relieve symptoms related to their illness.

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• Various historic and sociopolitical exigencies
  have contributed to the popularity of Ayurveda
  use for people living with HIV-AIDS.
• Early in the struggle with HIV, pharmacologic
  treatments were limited and often were
  accompanied by severe negative side effects that
  precluded their use.
• Later, with the advent of highly active
  antiretroviral therapies (HAART), access to these
  expensive therapies was limited for many
  communities.

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• THERE ARE MANY REASONS WHY PEOPLE LIVING WITH
  HIV/AIDS USE AYUSH TREATMENTS
• Limitations of Anti-retro Viral Drugs to be used
  in our country include
• 1 Restricted availability in our country.
• 2. Major side effects
• 3. High cost
• The physicians who work in integrated clinics
  that provide both conventional and complementary
  services may refer patients to these clinics for
  pain management, to learn adaptive coping
  strategies, to manage chronic and serious medical
  illness, and to manage HIV-related symptoms.

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• The social role of Ayurveda among people living
  with HIV-AIDS has been examined.
• Some studies have examined the effectiveness of
  Ayurveda on symptom management and improvement of
  quality of life .
• The management of HIV-related symptomatology has
  become important because people living with
  HIV-AIDS are living longer as a result of HAART.
• Acceptance that a cure for HIV will not be
  discovered in the near future has justifiably
  shifted attention to quality of life concerns for
  people living with HIV-AIDS and consequently
  redirected attention to improving the management
  of HIV-
• related symptoms
• In addition, individuals who choose not to use
  HAART, who have limited access to conventional
  treatments, or who cannot tolerate the side
  effects of HAART (highly active anti retro viral
  therapy) may turn to Ayurveda for relief of
  HIV-related symptoms.

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• AYURVEDA PROVIDES ..
• a comprehensive individualistic approach for
  the selection of appropriate therapy
  considering the body as a whole not merely
  treating the disease
• Besides this Ayurvedic
• -Rasayana
• -Swastavritta
• -Sadvritta
• provides various drugs /counseling regimens to
  combat
• stress related problems there by improving
  immunity and QOL.

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Kamya Rasayana To promote general, physical and
mental health(QOL) Naimittika Rasayana Used to
cure some particular diseases(Disease
oriented) Ajasrik Rasayana Used in the daily
routine of life to promote the general
health(QOL) Achara Rasayana Practice of good
conduct and desirable behavior in every aspect of
life(QOL)
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D I V E R S I F I E D E F F E C T S

• RASAYANA-BALAKARA (IMMUNO
  MODULATORY)
• OJOVARDHAKA (IMMUNO
  MODULATORY/POTENT
• 
  MICRO NUTRIENT)
• AYUSKARA
  (ADPTOGENIC/ANTIOXIDANT)
• AYUSHYA (
  ADAPTOGENIC)
• INDRIYA BALAPRADA (SUPPORTS THE
  SENSORY
• 
  AND MOTOR SYSTEMS)
• SMRITIKARA (MEMORY
  BUSTER)
• VRISYA (
  APHRODISIAC)
• VAYASTHAPANA (ANTI AGING
  ACTION)
• PUSTIKARA / BRIMHANA (POLYTROPIC TISSUE
• 
  TONIC)

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STRENGTH OF AYURVEDA -EXPERIMENTAL BASIS
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PROPHYLAXIS RECONSTITUTION OF GENERAL IMMUNE
RESPONSIVENESS

• Ayurvedic preparations act primarily by
  activating the macrophages.
• It increases the phagocytic activity of
  macrophges and also induces expression of MHC-II
  antigens indicating enhancement of their
  antigen-presenting ability.

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Reconstitution of general immune responsiveness
AYURVEDIC Agents with putative General immune
enhancing activity
Increases the phagocytic Activity of macrophages
.
Induces EXPRESSION OF MHC-II antigens indicating
enhancement Of their antigen-presenting ability
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AYURVEDIC PREPARATION, AS REPORTED MAY BE
MEDIATED BY ACTIVATION OF CELLULAR IMMUNE
RESPONSES

• In vitro, treatment of mice splenocytes with
  Ayurvedic preparations stimulated the production
  of IL-2, IFN-Gamma and TNF-Alpha reflecting
  activation of Th-1 type of T cell responses.
• Since Th-1 type of response has been implicated
  with the cell mediated immunity the therapeutic
  effects of Ayurvedic preparation, as reported may
  be mediated by activation of cellular immune
  responses.
• Infact, the antimicrobial properties of
  Ayurvedic preparation have found to be mediated
  by the immune system.

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Ayurvedic Preparation, As reported may be
mediated by activation of Cellular immune
Responses
Splenocytes Ayurvedic preparations
Stimulated the production of IL-2, IFN-Gamma
and TNF-Alpha
Activation of Th-1 type of t cell responses.
41
References

• Bhupinder Singh et al Ind.J.Pharmacol 13(1)
  96, 1981.
• Rege, N. et al, Indian Drugs, 21(12) 544-546,
  1984.
• Chopra R.N. et al, Gloss. Ind. Med. Plants CSIR,
  N. Delhi, 244, 1956.
• Thatte U M et al.J.Post.grad.Med.1994 40202-3
• Singh N., Curr. Med. Pract. 23(1) 50,1981.
• Singh N, Int.J.Crude Drugs Res. 29 29,
  1982.,Singh N. et al Int.J. Crude Drugs Res. 24
  90, 1986

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AIDS AND AYURVEDA

• In AIDS the patient losses something essential.
  The cellular immunity becomes defenseless against
  the pathogens and suffers from various clinical
  manifestations.
• These manifestations are similar to that of
  OJOKSHAYA or BALAKSHAYA patients, depicted in
  Ayurvedic classics.

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OJAS
AIDS AND AYURVEDA
AETIOLOGICAL FACTORS
OJO KSHAYA- AIDS
DHATU KSHAYA/DAURBALYA Cellular immunity
becomes defenseless against the pathogens
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• Administrating the rasayana medicaments meant for
  ojovardhaka, balavardaka (immuno
  modulation/adoptogenic and Nourishment) would
  help in Promote the process of dhatu poshana and
  enrich ojus and thus leads to improve the vital
  strength and immunity or vyadhi kshamatva
  (non-specific immunity) ultimately contribute in
• managing symptoms
• preventing Ois
• stress
• improving QOL.

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OJOVARDHAKA RASAYANA DRUGS
OJO VARDHANA IMMUNO MODULATION ANTI STRESS
ANTIOXIDANT MICRO NUTRIENT SYMPTOM MANAGEMENT
IMPROVED QOL
DHATU VARDHANA IMPROVED TISSUE FUNCTIONS
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Methodology -Development Of AYUSH QOL-2
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-Keeping the global prevalence of HIV/AIDS and
potentials of Ayurveda in view, the council has
formulated and developing AYUSH QOL-2 for
symptom management, Improvement of quality of
Life through extensive pre clinical
standardization /safety /targeted activity
studies.
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Objective
-The primary objective is to assess the safety
and therapeutic efficacy of AYUSH QOL-2, in the
symptom management, Improvement of quality of
Life, To study the immunological responses of the
therapy in HIV/AIDS patients with CD4Tcell
count ranging from 200- 450/cu.mm.
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SCHEMATIC REPRESENTATION OF DEVELOPMENT Literary
Survey Formulation of Hypothetical
Basis Formulation of Coded Drugs for identified
conditions Pre-clinical standarsation, toxicity,
biological activity (Completed) Drafting of
specific Protocols on each condition Approval
by Task Force of Experts (Completed) Clinical
Trial
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Drug preparation and standardization
The coded drug AYUSH QOL-2 has been prepared and
standardized by council adopting the WHO/Global
norms(including microbial growth, estimation of
pesticides, presence of adulterants, heavy metals
etc).
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STANDARDIZATION AYUSH QOL-2
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TLC profiles of ingredients

Toluene Ethyl Acetate
Chloroform methanol 93 7
90 10
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TLC profiles of ingredients

Benzene Ethyl Acetate 2
1
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TLC of Ayush QOL - 2
Solvent system n-Butanol Acetic acid Water
632710
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The preclinical safety and toxicity
(Acute/Sub-acute) studies have been conducted
adopting International norms and revealed its
safety.
SAFETY STUDIES
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BIOCHEMICAL PARAMETERS (MEAN ? SE)
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HAEMATOLOGICAL PAREAMETERS (MEAN ? SE)
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MEAN ORGAN WEIGHT ( BODY WEIGHT) ?SE
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HISTOPATHOLOGICAL PROFILES
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Section of Intestine showing normal villi lined
by columnar cells (VC, Female).
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Section of kidney showing normal glomeruli
(Ayush QOL 2(TD), Female).
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Section of Lung normal alveoli. (VC, Female)
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Section of Lung showing thickening of
interstitial tissue and collection of
lymphocytes around peribronchial region. (Ayush
QOL 2 (AD), female).
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Section of Liver showing normal portal areas and
hepatocytes. (VC, Female).
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Section of Ovary showing normal graffian
follicle and luteal cells. (VC).
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Section of Spleen showing normal lymphoid
follicles and germinal centres (VC, Female).
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Section of Stomach showing normal mucosal glands
lined by columnar cells (VC, Male).
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Section of Testis showing normal seminiferous
tubules (VC).
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- The /Biological activity study reveals
significant immunomodulator, adaptogenic
activities(antagonized the effect of
Cyclophosphamide and confirmed
immunomodulatory effect Plt0.001 ) which are
essential for improvement quality of life and
symptoms management in HIV/AIDS.
Targeted Biological activity Studies
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EVALUATION OF IMMUNOMODULATORY ACTIVITY OF AYUSH
QOL - 2 OBJECTIVE To evaluate the
immunomodulatory activity of Ayush Formulations
in different animal models. MATERIALS AND
METHODS Materials Ayurvedic formulation Ayush
QOL-2 Animals Albino Rats. Quarantine All
animals were acclimatized to laboratory
conditions for 7 days prior to study initiation.
Animals were observed for general health and
suitability for testing during this period. The
healthy animals were selected after the health
screen conducted by Veterinary physician.
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FORCED SWIMMING TEST
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Fig-1
INFERENCE 1. Cyclophosphamide has significantly
decreased the immobility period when compared to
control Plt0.001 2. Ayush QOL-2 has
antagonized the effect of Cyclophosphamide and
confirmed immunomodulatory effect Plt0.001
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TAIL SUSPENSION TEST
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INFERENCE I.Cyclophosphamide has significantly
decreased the immobility period when
compared to control Plt0.001 2.Ayush QOL-2 has
antagonized the effect of Cyclophosphamide and
confirmed immunomodulatory effect Plt0.001
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NEUTROPHIL COUNT
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Inference 1. Cyclophosphamide has significantly
decreased the neutrophils
counts Plt0.001 2. Ayush QOL-2
has antagonized the effect of Cyclophosphamide
and neutrophil count is
comparable with central group
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The following targeted activity studies are in
progress
1.To determine the effect of Aush QOL-2 on body
weight and hematological parameters such as TLC,
DLC Hb. 2.To determine the preliminary effect
of Ayush QOL-2 on stem cell proliferation. 3.To
determine the effect on the T Cell subjsets CD4
CD8 cells. 4.To study the effect on macrophage
mediated Phagocytosis. 5.To study the effect on
the proliferation of lymphocytes. 6.To study the
effect of Ayush QOL-2 on the level of cytokines
liberated by TH1 (IL-2, IFN-8), TH2 (IL-4, EL-6,
IL-10) and macrophages (IL-12, ILN-8) 7.To study
the effect of Ayush-QOL2 on the expression of TH1
and TH2, Cytokines. 8. In vitro anti retro viral
activity on cell lines.
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CLINICAL RESEARCH DESIGN AND METHODS
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HYPOTHESIS

• Ayurvedic formulation (Ayush QOL-2) is effective
  in improving immunological status in HIV
  infected patients and in combating symptoms and
  improves QOL in HIV/AIDS patents with CD4Tcell
  count ranging from 200- 450/cu.mm.

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Study population The study participants
will be screened from the patients attending out
patient department, based on inclusion and
exclusion criteria defined. Study Design
Randomized controlled study The eligible subjects
will be randomly allocated in to control and
intervention groups.  
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• Period of study
• The study will be open for one year. The eligible
  subjects shall be recruited in the study till
  this period. Total period for completion of the
  study and data analysis will be two years from
  the date of commencement of the study.
• Sample Size
• 200 subjects, 100 in each group will be randomly
  recruited in treatment and control groups. The
  treatment group will receive Ayurvedic drug twice
  in a day and control group will be given placebo
  glucose twice in a day

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• Inclusion criteria
•  Age group 20 to 50 years, irrespective of sex
• Seropositive to HIV1 by ELISA (3 tests)
• CD4 cell count ranging from 200-450/cu.mm
• Able to understand and give written consent
• Patients not receiving ART / any other medication
  

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Exclusion criteria
1. Pregnant or lactating females. 2.
Presence of serious systemic illness-Chronic
renal failure, hepatic failure, cardiovascular
diseases, endocrinal or metabolic disorders (such
as diabetes mellitus) etc.
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3.Patients suffering from secondary infections or
opportunistic infections like severe chronic
diarrhea, all types of pneumonias, disseminated
diseases, brain abscesses, meningitis,
encephalitis, herpes simplex, herpes zoster,
syphilis, pulmonary tuberculosis, and
pneumocystis carinii pneumonia, toxoplasmosis,
cytomegalovirus infection. 4.Patients with
neoplasm- visceral lymphomas, invasive cervical
carcinoma. Kaposis sarcoma
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• Criteria for withdrawal and Dropout
• Development/occurrence of a life
• threaten illness.
• Severe adverse effect of the drug.
• Non adherence to the treatment

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• End Points
• Change in symptoms assessed by the ESAS(The
  Edmontion Assessment scale) (patient related
  Visual analogue scale,(BreuraE, KuehnN,
  etal.1993), MSAS (Memorial Symptom Assessment
  Short-Form) ( Portenoy RK, Thaler HT, Kornblith
  AB, et al 1994).
• Weight change of 5 kilo grams or 10 of body
  weight
• Change in in Karnofsky Performance
• Confirmed change in CD4 T cell count of
  100/mm3, diagnosed AIDS by WHO clinical
  criteria of confirmed CD4T cells lt200 mm3.

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• Methods
• Special case record forms (CRF) developed are
  used for screening of the patients, periodical
  assessment of clinical status and assessment
  of laboratory parameters.
• Besides this ,Separate history form is developed
  to record gender, age, address, occupation,
  educational status, Marital Status, Family
  history, history of past ,and present illnesses
  risk behavior , sexual behavior.

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• Methods
• History of exposure towards medical causes like,
  Blood transfusion Blood products, Major surgery
  ,I.V drug use Needle pricks/ Needle stick, other
  relevant causes, Injury etc. Personal History on,
  active drug abuse, consumption of alcohol,
  smoking habit etc will also be recorded.

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• Methods
• Change in body weight, incidences of
  opportunistic infections Karnofsky performance
  score and clinical status of the patient
  fatigue, night sweats, anorexia, , diarrhea cough
  ,breathlessness, headache, vomiting edema,
  .dermatitis,. Herpes infection. Will be recorded
  .
• Details of past drug schedule covering name of
  medication, total daily duration (in days) and
  past adverse drug effects including name of drug
  details of adverse effects definite/possible will
  be recorded
• .

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• Assessment criteria
• The efficacy of the trail drug will be assessed
  on the basis of changes in clinical parameters as
  well as laboratory investigations.
• Clinical parameters
• Weight change
• Karnofsky performance score
• Opportunistic infections
• Monthly Change in symptom will be assessed by
  the ESAS( Edmontion Assessment scale) (patient
  related Visual analogue scale),(BreuraE, KuehnN,
  etal.1993), MSAS (Memorial Symptom Assessment
  Short-Form) ,)( Portenoy RK, Thaler HT, Kornblith
  AB, et al 1994) (Joseph F. ONeill et al.2003 ).
•  

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Clinical Parameters
 
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• Laboratory investigations
• ELISA (3 tests)
• CD4 count (two initial CD4 T Cell Measurements at
  l week apart)
• Beta-2 micro globulin level
• HIV RNA-viral load
• Hemoglobin
• Neopterin level

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• During study, patients will be screened for
  HIV/AIDS depending upon the investigations report
  and other clinical signs and symptoms. ELISA will
  be used for screening of HIV infections. Patients
  will be followed for a period of 12 months .
• CD4 count , (Two (2) CD4 T Cell Measurements at
  l week apart )Beta-2 micro globulin level, and
  Neopterin Viral load and gm of Hemoglobin will
  be investigated at 0 month with interval of 3
  months for 12 months .
• Other hematological, bio -chemical and
  radiological investigations will be done at 0
  month and 12th month.
•  

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• Intervention
• The treatment group will receive Ayurvedic drug
  (Ayush QOL-2)twice in a day and control group
  will be given placebo glucose twice in a day
• Group I Trail drug- 2 tablets (510 mg/tab) .
• Group II Placebo (glucose)- 2 tablets (510
  mg/tab) twice in a day before food with water
  for 12 months .

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• Data monitoring and Conduct of clinical
  study
• A Data and safety monitoring board(DSMB) will
  be established to carefully monitor the data
  and side effects during the period of study
  and put in a place where by prompt reporting of
  adverse events occur.
• The board periodically assesses the data and
  monitors the study.
• A clinical trial manual will be developed and a
  short training will be given to the research
  staff regarding the conduct of the study.
•  

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• General Management
• Patients will be managed on out patient level
  only. Physicians on the set (Case record form
  (CRF) make periodic assessment.
• Patients will be instructed to avoid other forms
  of medicines during the period of trail.
• They should report to the physicians immediately
  for appropriate treatment in the event of
  adverse relation.
•  

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• Confidentiality
• Strict confidentiality of all data collected will
  be maintained to prevent embarrassment or
  Victimization of patients.
• Consent form will be obtained from every patient.
•   Data analysis
• The, data on clinical and laboratory parameters
  taken into account for diagnosis and for the
  assessment will be tabulated and analyzed using
  suitable statistical method. (SPSS-VERSION -11)

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Thank You