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Title: development of ayush qol -2 for improvement of quality of


1
  • 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
2
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.

3
  • 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.

4
  • 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.

6
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
7
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)

8
  • 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.

9
  • 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.


10
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

11
NEW DRUG DEVELOPMENT
12
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

13
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)

14
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15
IPR PROTECTION AND COMMERCIALIZATION
16
COLLABORATIVE RESEARCH
17

18
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23
  • Development Of AYUSH QOL-2

24
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.

25
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.

26
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.
27
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,

28
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

29
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.

30
  • 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.

31
  • 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.

32
  • 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.

33
  • 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.

34
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)
35
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)

36
STRENGTH OF AYURVEDA -EXPERIMENTAL BASIS
37
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.

38
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
39
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.

40
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

42
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.

43
OJAS
AIDS AND AYURVEDA
AETIOLOGICAL FACTORS
OJO KSHAYA- AIDS
DHATU KSHAYA/DAURBALYA Cellular immunity
becomes defenseless against the pathogens
44
  • 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.

45
OJOVARDHAKA RASAYANA DRUGS
OJO VARDHANA IMMUNO MODULATION ANTI STRESS
ANTIOXIDANT MICRO NUTRIENT SYMPTOM MANAGEMENT
IMPROVED QOL
DHATU VARDHANA IMPROVED TISSUE FUNCTIONS
46
Methodology -Development Of AYUSH QOL-2
47
-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.
48
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.
49
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
50
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).
51
STANDARDIZATION AYUSH QOL-2
52
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53

TLC profiles of ingredients

Toluene Ethyl Acetate
Chloroform methanol 93 7
90 10
54

TLC profiles of ingredients

Benzene Ethyl Acetate 2
1
55
TLC of Ayush QOL - 2
Solvent system n-Butanol Acetic acid Water
632710
56
The preclinical safety and toxicity
(Acute/Sub-acute) studies have been conducted
adopting International norms and revealed its
safety.
SAFETY STUDIES
57
BIOCHEMICAL PARAMETERS (MEAN ? SE)
58
HAEMATOLOGICAL PAREAMETERS (MEAN ? SE)
59
MEAN ORGAN WEIGHT ( BODY WEIGHT) ?SE
60
HISTOPATHOLOGICAL PROFILES
61
Section of Intestine showing normal villi lined
by columnar cells (VC, Female).
62
Section of kidney showing normal glomeruli
(Ayush QOL 2(TD), Female).
63
Section of Lung normal alveoli. (VC, Female)
64
Section of Lung showing thickening of
interstitial tissue and collection of
lymphocytes around peribronchial region. (Ayush
QOL 2 (AD), female).
65
Section of Liver showing normal portal areas and
hepatocytes. (VC, Female).
66
Section of Ovary showing normal graffian
follicle and luteal cells. (VC).
67
Section of Spleen showing normal lymphoid
follicles and germinal centres (VC, Female).
68
Section of Stomach showing normal mucosal glands
lined by columnar cells (VC, Male).
69
Section of Testis showing normal seminiferous
tubules (VC).
70
- 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
71
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.
72
FORCED SWIMMING TEST
73
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75
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
76
TAIL SUSPENSION TEST
77
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78

79
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
80
NEUTROPHIL COUNT
81
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82
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
83
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.
84
CLINICAL RESEARCH DESIGN AND METHODS
85
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.

86
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.  
87
  • 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

88
  • 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

89
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.
90
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
91
  • Criteria for withdrawal and Dropout
  • Development/occurrence of a life
  • threaten illness.
  • Severe adverse effect of the drug.
  • Non adherence to the treatment

92
  • 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.

93
  • 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.

94
  • 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.

95
  • 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
  • .

96
  • 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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