Comparative clinical evaluation of an ayurvedic regimen in the management of senile dementia

Abstract

An enhanced life expectancy in developed countries has been accompanied by an increased number of people suffering from age-associated dementia. Senile dementia is a syndrome due to disease of the brain, usually of a chronic or progressive nature, in which there is disturbance of multiple higher cortical functions, without any impairment in consciousness. Prevalence rates for senile dementia increase essentially with advancing age. The prevalence rate rises to 54.8% in individuals above 95 years of age. So far, efforts to find a cure for Alzheimer Disease (AD) have been disappointing, and the drugs currently available to treat the disease address only its symptoms and with limited effectiveness. Present study was design to see the efficacy of Saraswata ghrita along with Shirobasti on Senile dementia. A total number of 34 patient of Senile dementia were recruited by using ICD- 10 criteria of Dementia and MMSE scores and randomly divided in to two groups. Alzheimer's disease assessment scale (cognitive subscale) has been used to evaluate the clinical condition of the patients of Senile dementia. After completion of treatment Saraswata ghrita along with Shirobasti shows statistically significant results on clinical and neuro-cognitive parameters.

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Ansari Obed Ahmed et al / Int. J. Res. Ayurveda Pharm. 4(3), May – Jun 2013
307
Research Article
www.ijrap.net
COMPARATIVE CLINICAL EVALUATION OF AN AYURVEDIC REGIMEN IN THE MANAGEMENT
OF SENILE DEMENTIA
Ansari Obed Ahmed1*, J. S. Tripathi1, I. S. Gambhir2
1Division of Manas Chikitsa, Dept. of Kayachikitsa, Institute of Medical Sciences, Banaras Hindu University, Varanasi,
U.P., India
2Division of Geriatric Medicine, Dept. Of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi,
U.P., India
Received on: 08 /01/13 Revised on: 10/02/13 Accepted on: 13/03/13
*Corresponding author
E-mail: obaidansari82@gmail.com
DOI: 10.7897/2277-4343.04301
Published by Moksha Publishing House. Website www.mokshaph.com
All rights reserved.
ABSTRACT
An enhanced life expectancy in developed countries has been accompanied by an increased number of people suffering from age-associated dementia.
Senile dementia is a syndrome due to disease of the brain, usually of a chronic or progressive nature, in which there is disturbance of multiple higher
cortical functions, without any impairment in consciousness. Prevalence rates for senile dementia increase essentially with advancing age. The
prevalence rate rises to 54.8% in individuals above 95 years of age. So far, efforts to find a cure for Alzhei mer Disease (AD) have been disappointing,
and t he drugs currentl y available to treat the disease address only it s symp toms and with limited effectiveness. Present study was design to see the
efficacy of Sara swata ghrit a along with Shirobasti o n Senile dementia. A total number of 34 pat ient of Senil e dementia were recruited by using ICD-
10 criteria of Dementia and MMSE scores and randomly divided in to two groups. Alzheimer’s disease assessment scal e (cognitive subscale) has
been used to evaluate the clinical condition of the patients of Senile dementia. After completi on of treatment Saras wata ghrit a along with Shirobasti
shows statistically significant results on clinical and neuro-cognitive parameters.
Keywords: Senile dementia, Saraswata ghrit a, Shirobasti
INTRODUCTION
An enhanced life expectancy in developed countries has
been accompanied by an increased number of people
suffering from age-associated Dementia. Senile dementia
is a syndrome due to disease of the brain, usually of a
chronic or progressive nature, in which there is
disturbance of multiple higher cortical functions,
including memory, thinking, orientation, comprehension,
calculation, learning capacity, language, and judgement
without any impairment in consciousness1. Prevalence
rates for Dementia increase essentially with advancing
age2. Persons above 60 years of age show 0.43%
prevalence whereas persons aged above 65 years show
2.44% prevalence. The prevalence rate rises to 54.8% in
individuals above 95 years of age3. There is a paucity of
modern drugs/agents facilitating acquisition, retention,
and retrieval of information and knowledge. Nootropic
agents such as piracetam4, cholinesterase inhibitors like
donepezil are being primarily used to improve memory,
mood and behaviour. However, the resulting adverse
effects associated with these agents have limited their
use5,6 and it is worthwhile to explore the utility of
traditional medicines in the treatment of various cognitive
disorders.
Ayurveda, the Indian system of medicine had developed
certain dietary and therapeutic measures to delay ageing
and rejuvenating whole functional dynamics of the body
organs. This revitalization and rejuvenation is known as
the ‘Rasayana chikitsa’ (rejuvenation therapy)7. Ayurveda
claims that several plants, the "Medhya" plants (intellect
promoting) which have been found beneficial in cognitive
disorders8. Saraswata ghrita mentioned in Bhaisajya
Ratnawali Svarbheda Rogadhikar9, is a unique
combination of Medhya drugs having high content of
Brahmi, which is a well known drug for its nootropic and
memory enhancing properties through various researches
and clinical studies10-12
.
Since Senile dementia is a disorder due to vitiated Vata
especially in old age, snehana is extremely recommended
for it and Shirobasti is said to be best in all type of
snehana of Moordha13. Also Moordha is the palace for
Prana vayu and all Indiryas14. Thus snehana of Moordha
will not only pacify the Prana vayu but also give
nourishment to the brain.
Medicine to be used in Shirobasti
According to Sushruta and Vagbhata, accordingly to
disease, medicated sneha should be poured in
Shirobasti15,16 and Ghrita is said to be best among the all
sneha, and further described as a Yogvahi rasayana means
any drug processed with ghrita will possess the quality of
added drug17. With this approach Saraswata ghrita is
selected to be used in Shirobasti.
Aims and Objectives
· To evaluate the effect of an Ayurvedic regimen
(Saraswata ghrita orally in combination with
therapeutic procedure Shirobasti) on clinical
symptoms in patients of Senile dementia.
· To evaluate effect of an Ayurvedic regimen
(Saraswata ghrita orally in combination with
therapeutic procedure Shirobasti) on neuro-cognitive
parameters–Alzheimer’s disease assessment scale in
patients of Senile dementia.

Ansari Obed Ahmed et al / Int. J. Res. Ayurveda Pharm. 4(3), May – Jun 2013
308
MATERIALS AND METHODS
A total number of 34 patients from OPD/IPD of
Department of Kayachikitsa and Department of Medicine,
S.S. Hospital IMS, BHU, presenting with clinical feature
of Senile dementia, were screened for any
neuropsychiatric disturbances and assigned into two
groups
· Group A - 25 patients – Saraswata ghrita 6gm
BD along with Shirobasti (with Saraswata
Ghrita).
· Group B - 09 patients - Placebo in the form of Lactulose
Cap. in dosage of 500mg BD
The following inclusion and exclusion diagnostic criteria
were applied for the selection of cases of Senile dementia.
Study was carried out as per the Ethical clearance no. 168.
Approved on 13.05.2011.
The Inclusion Criteria
· Patients aged 55 and above up to 85 years.
· The elderly patients who fulfilled the ICD-10
diagnostic criteria for Dementia and who have MMSE
score ≤23 were included in this study.
The Exclusion Criteria
· Impairment in cognitive functions due to Delirium.
· Impairment in memory without significant impairment
in other cognitive functions (i.e. Aphasia, Apraxia,
Agnosia or disturbance in executive functioning).
· Multiple cognitive deficits due the effect of substance
intoxication or substance withdrawal.
· Cognitive impairment due to any other psychiatric
disorder like Schizophrenia, Depressive disorder.
· Normal cognitive decline due to Age.
· Patients aged less than 55 and more than 85 years
were excluded.
Dose and administration
· Dosage of trial drug
Saraswata Ghrita 6gm twice a day orally with
lukewarm milk
· Total duration of trial
3 Months
· Follow-up
At interval of 1 month each
Schedule of Shirobasti
· Drug used: Saraswata Ghrita
· Quantity: 1 Liter
· Per day Duration: 45 min., daily
· Total Duration: 15 days, every month for three
consecutive months (Total 45 days)
Parameters for assessment of therapeutic response
Clinical parameters
The symptomatic relief produced by the trial treatment
was assessed on initial visit and on successive follow ups
at 1month intervals for entire period of therapeutic trial
i.e. for three months over the symptoms severity grading
scale ranging from 0-4.
Neuro-cognitive parameters
The effect of treatment was also assessed in terms of
certain neuro-cognitve factors. Alzheimer’s disease
Assessment Scale (ADAS)18 has been used to quantify the
neuro-cognitive parameters.
Assessment of the overall effect of the therapeutic trial
The overall result of the therapeutic trial has been
assessed on the basis of changes into total ADAS score
and the symptomatology. The reduction into the total
ADAS score less than 5 or an increase in ADAS score
was considered as no improvement or insignificant
improvement, reduction between 5 to 10 and minor
changes into the patients clinical condition was
considered as mild improvement., while the reduction
into the total ADAS score ranging between 10 to 16 was
considered as moderate improvement, if also associated
with significant changes into the patient’s clinical
condition. Excellent improvement has been considered if
the total reduction of ADAS score was more than 16 with
significant improvement in clinical symptoms.
OBSERVATION AND RESULTS
The observations and results have been presented under
the following tables
Table 1: Incidence of age and sex in 34 patients of Senile dementia
Age
(in yrs)
Male
Female
Total
No.
%
No.
%
60-65
9
26.5%
3
8.8%
12
66-70
9
26.5%
1
2.9%
10
71-75
3
8.8%
1
2.9%
4
76-85
4
11.8%
4
11.8%
8
Total
25
73.6%
9
26.4%
100%
Table 2: Group wise dist ribution of the patients of Senile dementia accordi ng to severity of cognitive impairment based on thei r MMSE score
Groups
Cognitive Dysfunction
Total
Mild (MMSE=18-23)
Moderate (MMSE=10-18)
Severe (MMSE˂10)
No.
%
No.
%
No.
%
Group A
13
52%
10
40%
2
8%
25
Group B
4
44.4%
5
55.6%
0
0%
9
Total
17
50%
15
44.1%
2
5.9%
34
MMSE = Mini Mental State Examination

Ansari Obed Ahmed et al / Int. J. Res. Ayurveda Pharm. 4(3), May – Jun 2013
309
Table 3: Effect on clinical symptomatology in 25 patients of Senile dementia treated with Saraswata g hrita in combination wit h Shirobasti
Symptoms
Mean Score ±SD
Difference
Relief
%
t value
p
Results
BT
AT
Forgetfulness
3.00±.764
2.64±.995
0.36
12%
3.674
<.01
HS
Impaired attention
2.72±.737
1.96±1.060
0.76
28%
7.268
<.001
HS
Object mislaid
3.56±.651
2.68±1.030
.88
24.7%
6.063
<.001
HS
Name forgotten
3.20±.957
2.16±.987
1.04
32.5%
11.438
<.001
HS
Number forgotten
3.52±.714
2.80±.913
0.72
20.4%
6.641
<.001
Hs
Difficulty in recognising family members and surroundings
2.32±1.376
1.68±1.345
0.64
27.5%
6.532
<.001
HS
Disturbed speech
1.92±1.187
1.52±1.229
.40
20.8%
3.162*
<.01
HS
Assistance in personal care
2.28±.980
1.96±1.060
0.32
14%
3.367
<.01
HS
Making mistakes in accounts
3.40±1.000
2.32±1.030
1.08
31%
9.448
<.001
HS
Delusional thoughts
1.60±1.443
1.24±1.000
0.36
22.5%
3.00*
<.01
HS
Irritability
3.08±.997
1.24±1.128
1.84
59.7%
13.37
<.001
HS
Disturbed sleep
2.24±1.200
1.04±1.060
1.2
53.5%
10.392
<.001
HS
Tremors
2.04±1.428
1.84±1.491
0.20
9.8%
2.236*
<.05
S
Disturbed gait
1.96±1.098
1.52±1.295
0.44
22.4%
4.34
<.001
HS
Anxiety
1.88±1.013
.72±.678
1.16
61.7%
4.284*
<.001
HS
Sad mood
1.36±1.319
.92±1.077
.44
32%
4.34
<.001
HS
Feeling of Weakness
2.36±.757
1.52±.872
0.84
35.6%
8.887
<.001
HS
BT= Before Treatment; AT= After Treatment. *values are calculated by using wilcoxon signed test due to SD was more than half of mean score
Table 4: Effect on Alzheimer’s Disease Assessment Scale (ADAS-cog s ubscale) score in 25 patients of Senile Dementia treate d with Saraswata
Ghrita in combination with Shirobasti
Tasks
Mean Score ± SD
Difference
Relief
%
t value
p
Results
BT
AT
Word recall task
7.56±1.87
5.16±2.19
2.40
31.47%
10.39
<.001
HS
Naming object task
2.56±1.04
1.60±1.22
0.96
37.5%
8.913
<.001
HS
Commands
2.24±1.48
1.48±1.47
0.76
33.9%
3.58*
<.001
HS
Constructional praxis
2.92±1.52
2.48±1.47
0.44
15%
3.773
<.01
HS
Ideational praxis
3.68±1.180
3.08±1.552
0.60
16%
4.648
<.001
HS
Orientation
4.92±1.352
3.08±1.382
1.84
37.3%
14.73
<.001
HS
Word recognition task
9.44±1.294
6.60±1.958
2.84
30%
11.381
<.001
HS
Remembering task
3.72±.936
2.64±1.036
1.08
29%
13.50
<.001
HS
Spoken language abilit y
3.08+1.038
2.72+1.329
0.36
11%
3.674
<.01
HS
Word finding difficulty in speech
3.04±.841
2.84±.987
0.20
6.5%
2.449
<.05
S
Comprehension
3.16±.850
2.84±1.06
0.32
10%
3.361
<.01
HS
Total ADAS score
46.28±11.17
34.48±13.69
11.80
25.5%
15.319
<.001
HS
*values are calculated by using Wilcoxon signed test due to SD was more t han half of mean score
Table 5: Effect on clinical symptomatology in 9 patients of Senile dementia treated with Placebo
Symptoms
Mean Score ± SD
Difference
Relief
%
T
p
Results
BT
AT
Forgetfulness
3.22±.667
3.33±.707
-0.11
--
-1.000
>.05
NS
Impaired attention
2.56±.527
3.00±.707
-0.44
---
-2.530
<.05
S
Object mislaid
3.33±1.000
3.22±1.093
-0.11
--
1.00
>.05
NS
Name forgotten
3.22±.833
3.56±.527
-0.34
---
-2.00
>.05
NS
Number forgotten
3.44±.726
3.44±1.014
--
--
.000
>.05
NS
Difficulty in recognising family members and surroundings
2.44±.726
2.89±.782
-0.45
--
-2.530
<.05
S
Disturbed speech
1.89±.782
2.00±.866
-0.11
--
-1.00*
>.05
NS
Assistance in personal care
2.22±.972
2.67±1.000
-0.45
--
-2.530
<.05
S
Making mistakes in accounts
3.44±.726
3.78±.441
-0.34
--
-2.00
>.05
NS
Delusional thoughts
1.67±1.414
1.89±1.364
-0.22
--
-1.41*
>.05
NS
Irritability
2.56±.726
2.89±.928
-0.33
--
-1.414
>.05
NS
Disturbed sleep
2.22±.833
2.56±.527
-0.34
--
-1.414
>.05
NS
Tremors
1.78±.833
1.78±.972
---
--
.000
>.05
NS
Disturbed gait
1.89±.928
2.11±.782
-0.22
--
-1.512
>.05
NS
Anxiety
1.67±1.000
1.78±1.202
-0.11
--
.333*
>.05
NS
Sad mood
1.44±1.014
1.56±1.130
-0.12
--
.555
>.05
NS
Feeling of Weakness
2.22±.667
2.78±.833
-0.56
--
-2.294
>.05
NS
*values are calculated by using wilcoxon sign test due to SD was more than half of mean score

Ansari Obed Ahmed et al / Int. J. Res. Ayurveda Pharm. 4(3), May – Jun 2013
310
Table 6: Effect on Alzheimer’s Disease Assessment Scale (ADAS-cog s ubscale) score in 9 patients of Senile Dementia treated with Placebo
Tasks
Mean Score ± SD
Difference
Relief
%
t value
p
Results
BT
AT
Word recall task
7.00±1.58
7.78±1.85
-0.78
--
-5.292
<.05
S
Naming object task
2.89±1.05
2.89±1.05
--
--
.000
>.05
NS
Commands
2.00±1.22
2.11±1.36
-0.11
--
1.000*
>.05
NS
Constructional praxis
2.67±1.34
2.67±1.34
--
--
.000
>.05
NS
Ideational praxis
3.22±1.202
3.33±1.32
-0.11
--
-1.00
>.05
NS
Orientation
4.44±1.333
4.89±1.364
-0.45
--
-2.53
<.05
S
Word recognition task
8.67±1.803
9.44±1.878
-0.77
--
-5.292
<.05
S
Remembering task
3.33+1.225
3.56+.882
-0.23
--
-1.512
>.05
NS
Spoken language abilit y
2.56+1.014
2.56+1.014
--
--
.000
>.05
NS
Word finding difficulty in speech
2.67±1.000
2.67±1.000
--
--
.000
>.05
NS
Comprehension
2.78±1.093
2.78±1.093
--
--
.000
>.05
NS
Total ADAS score
42.22±12.15
44.67±12.05
-2.45
--
-13.91
<.01
HS
*values are calculated by using wilcoxon sign test due to SD was more than half of mean score
Table 7: Overall result of the therapeutic trial among the all groups in the patie nts of Senile dementia
Result
Group A
Group B
Total
No.
%
No.
%
Mild improvement
6
24%
0
0%
6
Moderate improvement
13
52%
0
0%
13
Excellent improvement
3
12%
0
0%
3
No/insignificant improvement
3
12%
9
100%
12
Total
25
9
34
DISCUSSION
Interest in the study and care of patients with dementia
has greatly been increased, as at present it is the burning
problem of the presenile and senile age. At present time,
no treatment is available to alter the relentless
deterioration of the disease. A number of attempts have
been made for neurotransmitter replacement therapy in
Alzheimer's type dementia, but the overall management
was very difficult and frustrating as there is no specific
treatment available. Therefore, an attempt has been made
to manage this disease by an Ayurvedic regimen.
The study related with incidence of age and sex revealed
that maximum number of patients was found to be
between age group of 60-70 yrs (64.7%) with
predominance of Male patients (73.6%). Observations
regarding the level of cognitive impairment in these
patients, based upon MMSE scores revealed that, 50%
patients were found to be have mild cognitive
impairment, 44.1% have moderate, and only 5.9% have
the severe impairment. After completion of the trial
patients of Group A showed statistically highly significant
changes in all the symptoms except in tremor. Patients
also have performed very well in different component of
ADAS scale in consecutives follow ups . In patients of
Group B, no statistically significant difference was found
in any of the symptoms. They also performed very poorly
in ADAS scale in consecutive follow-ups.
After completion of the therapeutic trial, on the bases of
overall improvement, in patients of Group A treated with
Saraswata ghrita and Shirobasti, only 3 (12%) patients
were having no/insignificant improvements, while rest of
the patients demonstrated statistically significant
improvement on clinical symptoms and neuro-cognitive
parameters of ADAS scale. In the patients of group B
treated with Placebo, none of the patients showed any
significant improvements. Instead of getting
improvement, some patient with advance disease showed
more poor performance on clinical scales after completion
of trial. This finding is consistent with the progressive
nature of the disease.
Senile dementia is not described as a disease moiety in
separate chapters of Ayurvedic classics, however, The
symptoms of Senile dementia can be correlated with
Buddhi bhransha which has been described by Charaka in
Sharira sthan19. Since Smriti is closely interrelated with
Buddhi,20 so any derangement of Buddhi leads to
disturbance in Smriti and its other component like Dhi,
Dhriti and the vice-versa.
Ayurveda describes Rasayana therapy which is the unique
therapeutic modality to rejuvenate the body and mind21.
Further, Rasayana drugs acts by enhancing the digestion
and metabolism, the nutritional quality of nutrient plasma
(Rasa) and micro-circulation of nutrient materials to the
different basic body tissues22. Medhya Rasayans specially
improves the mental functions like memory, intellect etc.
along with quality of life23.
Saraswata Ghrita is a unique combination of such type of
Medhya and Rasayana drug described in Bhaisajya
Ratnavali,9 having high contents of Brahmi which is well
known drug for its nootropic properties and has been
proven through various clinical and experimental study10-
12. Saraswata ghrita also contain Rasayana drug like
Haritaki and Amlaki, which have been said to be best
among all “Vayasthapana dravya”.24,25 Ghrita is enriched
with drugs like Haridra, Vidanga and Pippali, and Vacha
which are having Shirovirechana property which removes
the vitiated Doshas for Shiras26. The whole formulation is
in Ghrita form, it improves Memory, Complexion,
Intelligence, Voice, and Oja the body. It is Vitalising,
Rejuvenating, Vrishya, Medhya and Vayasthapana,
promotor of long life and it removes toxic substances
from the body27. Moreover lipophilic action of Ghrita

Ansari Obed Ahmed et al / Int. J. Res. Ayurveda Pharm. 4(3), May – Jun 2013
311
facilitates transportation of drug to a target organ and
final delivery inside the cell, because cell membrane also
contains lipid. When herbs are mixed with Ghrita, their
activity and utility is potentiated many times28.
Shirobasti is specifically selected here to study its efficacy
on Senile dementia as it belongs to Snehana, especially
Bahyasneha and it is suggested as line of treatment of
vitiated Vata in almost all Ayurvedic texts. Shirobasti is a
snigdha sweda yukta procedure i.e it has dual benefits of
both Snehana and Swedana. Thermal therapy is known to
enhance antioxidant functions29 hence swedana procedure
may also facilitates a similar action. In Shirobasti, there is
retention of oil in lukewarm state for a specific period of
time on scalp of head region, which is a main seat of
Prana Vata and all Indriyas are also attached to
Moordha14.Thus, virtues of Sneha can be obtained here to
its best. This is also supported by Ashtanga Hridaya, i.e.,
Shirobasti is the most effective of all type of Moordha
taila13. Study suggests that drug if suitably formulated
can be delivered directly to the brain via transcranial
route30. As the nervous system is mainly composed of
lipoid tissue, the Ghrita being lipid in nature is quickly
absorbed due to the rich vasculature of the scalp and gets
distributed to different parts of the brain through the
communicating veins (extracranial to intra cranial),
exerting its influence on various centres, including the
limbic system and the hypothalamus.
CONCLUSION
Based on the findings of the present clinical trial, it can be
concluded that the combination of the Saraswata Ghrita
and Shirobasti therapy is one of the most effective
therapy for the management of the Senile Dementia
without any adverse and side effects, instead promoting a
greater degree of relief in the symptoms. It has been
observed that the improvement of the patients largely
depends on their level of cognitive impairment, greater
the level of impairment the more difficult it becomes to
treat, as the disease becomes intractable with time. Thus
the therapeutic combination of Saraswata ghrita orally
along with Shirobasti therapy can be judiciously used in
the intractable and progressive disorder of Senile
dementia with significant clinical benefits and
improvements in quality of life of these patients.
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Cite this article as:
Ansari Obed Ahmed, J. S. Tripathi, I. S. Gambhir. Comparative clinical
evaluation of an Ayurvedi c regimen i n t he management of Senil e
dementia. Int. J. Res. Ayurveda Pharm. 2013;4(3):307-311 .