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 /
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
(4) Yukti (experimental evidence) etc. which are
•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
Emphasis Of Ayurveda On Integration – A Key issue
•Understands mind-body & spirit connection, believes in
body’s 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
•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,
•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.
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
of research in Ayurveda and Siddha Systems of
Medicine on scientific lines.
Central Research institute Regional Research institute Research Units/Centres
10 16 12
Ayurveda Siddha Ayurveda Siddha Ayurveda Siddha
New Delhi Patna Pondicherry Hastinapur Palayamkottai [CRU]
ALRCA Palayamkottai [SMPU]
1. Literary Research (Revival and retrieval of rare books
2. Fundamental research (Anukta dravyas, Prakriti)
3. Drug research
4. Clinical Research
5. RCH Research
6. Neutraceutical Research (Antartica Tea and Antartica
laddu, food supplement for school going children )
7. Cosmeceutical Research (AYUSH face pack)
8. Bio Medical Instrumentation Research ( Panchkarma
• 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
• Pippalyadi Yoga an oral contraceptive for females.
(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
- Books and Monographs Published >90
- 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
- Microfilms – 272
NEW DRUG DEVELOPMENT
S.No. Area Status
1 Identification of priority areas and 30 coded drugs have been formulated
formulation of coded drugs for new for different disease conditions based
programme projection on national priority considering the
strength of Ayurveda
2 Literary survey and formulation Extensive literary documentation has
Hypothetical basis on each formulation been done on 30 coded drugs and got
and approval of scientific advisory the approval of SAC
3 Development of trial protocols for the 15 protocols on identified diseases
identified conditions. conditions have been completed and
preparation for other protocols are in
4 Pre-clinical standardisation and toxicity Eight formulations have completed.
5 Biological/ Targeted activities One formulation completed and others
are in progress.
6 Trial drug preparation
Preparation of eight formulations in
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
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
7. Ayush-BA for Tamaka Swasa
8. Ayush-VJ-1and -Ayush-VJ-2 for Malaria (Vishama
PROJECTS OF NATIONAL & GLOBAL
JAMA DRUGS PIPPALIYADI YOGA BIOMEDICAL
IPR PROTECTION AND COMMERCIALIZATION
1 Patents obtained 19
2 Patents filed/processing for filing 12
3 Patents /Processes released to the Industry 6
CCRAS Institutes Collaborating Institutes Research Area
CCRAS Rashtrapathi Bhavan Preparation of certain
Head Quarters (RPB) Ayurvedic Medicine by
using the Herbal
Rashtrapathi Bhavan and
Fragrance & Flavor
CCRAS NIN, Hyderabad. To develop Nutritional
Head Quarters & supplement for
AMUL, Gujarat • School going Children
• Pregnant women
• Geriatric population
RRIA, Kothrud, Pune Bhide foundation 1. Analytical study of
Pune Bhasmas (Rasmanikya)
2. Project entitled,
studies and clinical trials
Comprehensive study” (In
CCRAS, Hqrs. University of Delhi Genetic susceptibility to
National Institute of rheumatoid arthritis using
immunology and Holy a novel combination of
family Hospital, Delhi prakriti based control
selection & molecular
CCRAS Hqrs / CCMB (CSIR) Clinical evaluation of
CRI, New Delhi Hyderabad AYUSH-CT drops in
improving the quality of
vision and visual acuity in
age related immature
cataract (In progress)
CCRAS Hqrs / AIIMS Delhi Under process Clinical Studies of AYUSH-
CRI, New Delhi CT in age related immature
cataract (In progress,
Ethical clearance awaited)
CCRAS Hqrs / AIIMS Delhi Under process Clinical Evaluation of
CRI,New Delhi AYUSH-DE Drops in Dry
Eye Syndrome (In progress,
Ethical clearance awaited)
CCRAS Hqrs / AIIMS Delhi Under process Clinical Evaluation of
CRI,New Delhi AYUSH-AC Drops in Simple
Allergic Conjunctivitis (In
progress, Ethical clearance
CCRAS Hqrs / IIT, New Delhi Atomization of
CRI,New Delhi Panchakarma Equipments
Shirodhara & Kshara sutra-
(in ogress) Sarvanga Dhara-
Clinical Research Unit, NIMHANS, Banglore Autonomic functions tests in
Banglore patients with depression
(vishada) Role of Ayurvedic
therapy ad transcranial
Efficacy of Manasamitram
Vadakam on Generalized
Anxiety Disorder : A
polysomnographic Study –
Efficacy of Ayurvedic treatment
for motor weakness due to
ischemic stroke a prospective,
randomized, controlled study
Central Research TATA Cancer Research 1. Improvement of quality of
Institute, Mumbai Institute life in Cancer patients (Study
will be initiated shortly)
2.Screening of Herbal drugs for
potential anti-Cancer activity
(in the process of finalization)
Central Research Grant Medical College & Improvement of quality of
Institute, Mumbai J.J. Hospital, Mumbai life in AIDS/HIV patients –
CCRAS Hqs M/S Nath Agricultural Development of topical
foundation& Cold storage analgesic & anti
company inflammatory agent from
C. longa leaf oil
CRI, Siddha, Chennai Dept. of Orthopedics, Asthi saushirya
kilpauk Medical college (Osteoporosis)– Pre-
Chennai clinical studies completed.
CRI, Siddha, Chennai ANNA Peripheral Hospital Yakrit Vikar (Hepatitis – B)
attached to kilpauk preclinical studies
Medical college Chennai completed
CRI, Siddha, Chennai Women & Children Rakta Pradar
Hospital, Egmore, (Dysfunctional Uterine
CCRAS Hqs. (Funded NIPER (CSIR), Mohali Standardization, Shelf
by Dept. of Family Life, Stability, Biological
Welfare) Activity , Bio Availability
Receptor Assay of
Pippalyadi Yoga Capsule -
A Female oral
contraceptive - in
CCRAS Hqs. NIN,Hyderabad Toxicity studies of five coded
formulations for Urolithiasis,
Menopausal syndrome, Cardiac
Risk Factor, Rasayana for
elderly person, Diabetes
CCRAS Hqs Sports authority Development of wound healing
of India Pharmacological drugs for sports injury - under
Research Unit process
CCRAS at GAU, Jamnagar
Development Of AYUSH QOL-2
•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
•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.
•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, >1%in Hyderabad,
Banglore, Chennai and <1% in Kolkata, Ahmedabad and Delhi. The national prevalence
percentage, however, is currently 0.91%.
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 >5% and >1% in antenatal women.
Group 2: States of Gujarat, Pondicherry where HIV prevalence in
general population is >5% and in antenatal women <1%.
Group 3: Those states where HIV prevalence in general
population is <5% and in antenatal women is <1%.
•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
• 31.32lakh are male among the total number of
persons infected with HIV,
In spite of recent advances in the treatment of HIV/AIDS, there is
no known cure: the final outcome for every HIV-infected patient
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
ROLE OF AYUSH
The most prevalent users of Ayurveda /TSM are
individuals who have incurable, non–life-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.
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.
THERE ARE MANY REASONS WHY PEOPLE LIVING
WITH HIV/AIDS USE AYUSH TREATMENTS
Limitations of Anti-retro Viral Drugs to be used in our
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
The social role of Ayurveda among people living with HIV-AIDS has been
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-
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.
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
provides various drugs /counseling regimens to combat
stress related problems there by improving immunity and
Kamya Rasayana: To promote general, physical and mental
Naimittika Rasayana: Used to cure some particular
Ajasrik Rasayana: Used in the daily routine of life to promote the
Achara Rasayana: Practice of good conduct and desirable
behavior in every aspect of life(QOL)
R •RASAYANA-BALAKARA (IMMUNO MODULATORY)
•OJOVARDHAKA (IMMUNO MODULATORY/POTENT
S MICRO NUTRIENT)
I •AYUSKARA (ADPTOGENIC/ANTIOXIDANT)
F •AYUSHYA ( ADAPTOGENIC)
•INDRIYA BALAPRADA (SUPPORTS THE SENSORY
AND MOTOR SYSTEMS)
E •SMRITIKARA (MEMORY BUSTER)
D •VRISYA ( APHRODISIAC)
•VAYASTHAPANA (ANTI AGING ACTION)
•PUSTIKARA / BRIMHANA (POLYTROPIC TISSUE
STRENGTH OF AYURVEDA -
RECONSTITUTION OF GENERAL IMMUNE
• Ayurvedic preparations act primarily by activating
• It increases the phagocytic activity of macrophges
and also induces expression of MHC-II antigens
indicating enhancement of their antigen-presenting
Agents with putative responsiveness
immune enhancing activity
Increases the phagocytic
Activity of macrophages
OF MHC-II antigens
indicating enhancement Of
AYURVEDIC PREPARATION, AS REPORTED MAY BE
MEDIATED BY ACTIVATION OF CELLULAR IMMUNE
•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
Splenocytes + Preparation,
Ayurvedic As reported may
preparations be mediated
by activation of
of IL-2, IFN-Gamma
Th-1 type of t cell responses.
1. Bhupinder Singh et al – Ind.J.Pharmacol 13(1): 96, 1981.
2. Rege, N. et al, Indian Drugs, 21(12): 544-546, 1984.
3. Chopra R.N. et al, Gloss. Ind. Med. Plants CSIR, N. Delhi,
4. Thatte U M et al.J.Post.grad.Med.1994; 40:202-3
5. Singh N., Curr. Med. Pract. 23(1) 50,1981.
6. Singh N, Int.J.Crude Drugs Res. 29: 29, 1982.,Singh N. et al
Int.J. Crude Drugs Res. 24: 90, 1986
AIDS AND AYURVEDA
•In AIDS the patient losses something essential.
The cellular immunity becomes defenseless
against the pathogens and suffers from various
•These manifestations are similar to that of
OJOKSHAYA or BALAKSHAYA patients,
depicted in Ayurvedic classics.
OJAS AIDS AND AYURVEDA
against the pathogens
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
• improving QOL.
Methodology -Development Of
-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
-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 CD4+Tcell count ranging from 200-
SCHEMATIC REPRESENTATION OF DEVELOPMENT
Formulation of Hypothetical Basis
Formulation of Coded Drugs for identified conditions
Pre-clinical standarsation, toxicity, biological activity
Drafting of specific Protocols on each condition
Approval by Task Force of Experts (Completed)
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).
STANDARDIZATION AYUSH – QOL-2
Ayush – Description: Dark brown moderately fine powder with characteristic
Ash % 11.63 11.60 11.62
Acid-insoluble ash % 0.79 0.30 0.63
Water-soluble extractive % 51.39 53.61 52.50
Alcohol-soluble extractive % 21.75 22.33 22.04
Loss on drying at 105C % 14.10 14.80 14.45
pH (5% aq. solution) 4.60
Bulk density g/cc 0.55
Tap density g/cc 0.63
Calcium % 0.30 0.295 0.30
Total sugar % 12.37 12.44 12.41
Reducing sugar % 5.65 5.69 5.67
Non reducing sugar % 6.72 6.75 6.74
Sulphur % 1.65 1.72 1.69
Calcium % 0.30 0.295 0.30
Total viable aerobic count 3.3 x 103 col/g
Total Enterobacteriaceae Nil
Total fungal count Nil
Test for specific Pathogen
E. coli Nil
Salmonella sp. Nil
S. aureus Nil
Pseudomonas aeruginosa Nil
Lethal dose No mortality and toxic symptoms upto
a dose level of 5 g/kg body wt.
TLC profiles of ingredients
Toluene : Ethyl Acetate Chloroform : methanol
93 : 7 90 : 10
TLC profiles of ingredients
Benzene : Ethyl Acetate
TLC of Ayush QOL - 2
Solvent system: n-Butanol : Acetic acid : Water 63:27:10
The preclinical safety and toxicity (Acute/Sub-acute)
studies have been conducted adopting
International norms and revealed its safety.
BIOCHEMICAL PARAMETERS (MEAN SE)
Blood Glucose Serum SGOT SGPT
(mg %) Creatinine (U/L) (U/L)
14 d 28 d 14 d 28 d 14 d 28 d 14 d 28 d
CONTROL 82.75 81.5 0.8 1.05 177.75 150.25 76.5 65.75
10.80 9.6 0.0 0.00 15.84 8.42 7.39 12.53
TD 82.75 81 0.8 1.05 157 165.5 70.25 66.5
7.87 6.95 0.001 0.005 9.7 1.7 7.37 9.32
AD 88.75 85 0.8 1.02 185.75 163.25 81.25 65.25
9.1 8.34 0.0 0.00 5.58 15.37 15.213 6.48
HD 94.25 91.5 0.62 1.05 158.5 151.5 53.5 50.5
10. 9.53 0.0025 0.005 9.68 10.44 4.9 4.55
HAEMATOLOGICAL PAREAMETERS (MEAN SE)
CONTROL TD AD HD
Hb 14 d 12.8 ±0.045 12.3 ± 0.41 12.5 ± 0.31 12.1 ± 0.39
28 d 13.3 ± 0.44 11.8 ± 0.65 12.1 ± 0.45 11.9 ± 0.5
PCV 14 d 50.5 ± 4.01 48 ± 2.34 50 ± 5.01 48.2 ± 3.06
28 d 57.5 ± 7.48 51.2 ± 6.01 46.7 ± 2.59 48.2 ± 2.32
TRC 14 d 4.3 ± 0.006 4.6 ± 0.009 4.1 ± 0.26 ** 4.4 ± 0.32*
(106 / cu.mm)
28 d 4.8 ± 0.17 4.3 ± 0.12 3.4 ± 0.15 3.9 ± 0.23
TLC 14 d 4.8 ± 0.31 4.7 ± 0.41 5.6 ± 0.27 4.8 ± 0.23
(103 / cu.mm)
28 d 5.2 ± 0.11 5.1 ± 0.32 4.8 ± 0.43 5.3 ± 0.38
POLY 14 d 40.7 ± 4.46 32.2 ± 3.35 43.2 ± 1.43 37.5 ± 2.84
28 d 37.7 ± 0.85 46.5 ± 1.84* 30.5 ± 3.30 36.5 ± 3.17
LYM 14 d 59.2 ± 4.46 67.7 ± 3.35 56.7 ± 1.43 57.7 ± 1.91
28 d 62.2 ± 0.85 53.5 ± 1.84* 69.5 ± 3.3 63.5 ± 3.17
PT 14 d 11 ± 0.35 12.25 ± 1.26 13 ± 1.47 11 ± 0.7
28 d 9.25 ± 0.32 9.37 ± 0.55 10.62 ±0.55 11 ± 0.25
MEAN ORGAN WEIGHT (% BODY WEIGHT) SE
Liver Spleen Kidney Heart Teste ovary
Mal Fema Male Fema Male Fema Male Femal
e le le le e
Control 4.23 4.51 0.31 0.25 1.18 0.8 0.57 0.54 1.27 0.117
0.2 0.12 0.001 0.001 0.00 0.009 0.00 0.002 0.002 0.012
1 27 3 35 5
TD 4.87 4.27 0.46 0.36 1.04 0.86 0.71 0.47 1.55 0.096
0.28 0.11 0.00 0.008 0.00 0.003 0.111 0.004 0.108 0.004
58 5 44 4 3 3 9
AD 3.93 3.97 0.27 0.29 0.96 0.91 0.6 0.46 1.42 0.096
0.16 0.14 0.00 0.001 0.00 0.001 0.00 0.003 0.008 0.006
28 8 68 6 51 8 5
HD 3.67 4.44 0.25 0.28 0.9 0.82 0.42 0.47 1.69 0.101
0.11 0.22 0.00 0.001 0.00 0.003 0.00 0.003 0.005 0.01
18 8 12 2 17 4 6
Section of Intestine showing normal villi
lined by columnar cells (VC, Female).
Section of kidney showing normal
glomeruli (Ayush QOL 2(TD), Female).
Section of Lung normal alveoli. (VC, Female)
Section of Lung showing thickening of interstitial tissue
and collection of
lymphocytes around peribronchial region.
(Ayush QOL 2 (AD), female).
Section of Liver showing normal portal areas
and hepatocytes. (VC, Female).
Section of Ovary showing normal graffian
follicle and luteal cells. (VC).
Section of Spleen showing normal lymphoid
follicles and germinal centres (VC, Female).
Section of Stomach showing normal mucosal
glands lined by columnar cells (VC, Male).
Section of Testis showing normal seminiferous
Targeted Biological activity Studies
- The /Biological activity study reveals significant
immunomodulator, adaptogenic activities(antagonized
the effect of Cyclophosphamide and confirmed
immunomodulatory effect * P<0.001 ) which are
essential for improvement quality of life and symptoms
management in HIV/AIDS.
EVALUATION OF IMMUNOMODULATORY ACTIVITY OF
AYUSH QOL - 2
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.
FORCED SWIMMING TEST
INFLUENCE OF AYUSH QOL-2
ON FORCED SWIM TEST IN ALBINO MICE
11th 12th 13th
* * *
CONTROL AYUSH QOL-2 AYUSH QOL-2 CYCLOPHOSPHAMIDE
1. Cyclophosphamide has significantly decreased the immobility period when compared to control *
2. Ayush QOL-2 has antagonized the effect of Cyclophosphamide and confirmed
immunomodulatory effect * P<0.001
TAIL SUSPENSION TEST
INFLUENCE OF AYUSH QOL-2 ON
TAIL SUSPENSION TEST
11th 12th 13th
* * *
50.00 * *
C ON T R OL A Y U S H Q O L- 2 A Y U S H Q O L- 2 C Y C LO P HO S P HA M I D E
+C Y C LO P HS P HA M I D E
I.Cyclophosphamide has significantly decreased the immobility period
when compared to control * P<0.001
2.Ayush QOL-2 has antagonized the effect of Cyclophosphamide and
confirmed immunomodulatory effect * P<0.001
BLOOD NEUTROPHIL COUNT AFTER
14 DAYS ADMINISTRATION OF AYUSH QOL-2
0.00 C ON T R OL A Y U SH Q O L- 2 A Y U SH Q O L- C Y C LO PHO SPHA M I D E
2 +C Y C LO PHSPHA M I D E
Inference: 1. Cyclophosphamide has significantly decreased the neutrophils
2. Ayush QOL-2 has antagonized the effect of Cyclophosphamide
and neutrophil count is comparable with central group
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
3.To determine the effect on the T Cell subjsets CD4+ & CD8+
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
8. In vitro anti retro viral activity on cell lines.
CLINICAL RESEARCH DESIGN AND
• 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 CD4+Tcell count
ranging from 200- 450/cu.mm.
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.
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.
• 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
1. Age group – 20 to 50 years, irrespective of sex
2. Seropositive to HIV1 by ELISA (3 tests)
3. CD4 cell count ranging from 200-450/cu.mm
4. Able to understand and give written consent
5. Patients not receiving ART / any other medication
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.
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,
4.Patients with neoplasm- visceral lymphomas, invasive
cervical carcinoma. Kaposi’s sarcoma
Criteria for withdrawal and Dropout
•Development/occurrence of a life
•Severe adverse effect of the drug.
•Non adherence to the treatment
•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
CD4+T cells <200 mm3.
•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.
•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.
•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
•The efficacy of the trail drug will be assessed on the basis
of changes in clinical parameters as well as laboratory
• Karnofsky performance score
•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. O’Neill et al.2003 ).
Clinical Parameters Before the study Follow-up period (in months)
0 1 2 3 4 5 6
Iii. Incidences of
iv. Clinical Status of the Patient
3. Night sweats
1. ELISA (3 tests)
2. CD4 count (two initial CD4 T Cell Measurements
at l week apart)
3. Beta-2 micro globulin level
4. HIV RNA-viral load
5. Hemoglobin %
6. Neopterin level
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.
Laboratory Parameters Before the trail Follow-up period (in months)
0 1ST 3 6
2. Beta-2 micro globulin ---
3 HIV RNA. Viral load ---
4. Hemoglobin (gm%) ----
5. Neopterin level ---
Follow-up period (in months)
9 12 REMARKS
• 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 .
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
• 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.
• 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.
•Strict confidentiality of all data collected will be
maintained to prevent embarrassment or
Victimization of patients.
•Consent form will be obtained from every patient.
• 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)