Effect
of Rasayana Ghana tablet (An Ayurvedic formulation)
on improving quality of life of stressed individuals
Research
article
Deole Yogesh S1*,
Thakar A B2, Chandola
H M3, Ravishankar B4
1. Lecturer,
Department of Kayachikitsa, GJ Patel Institute of
Ayurvedic Studies and Research,New Vallabh Vidya Nagar,Gujarat
2. Reader,
Department of Panchakarma,
3. Professor
of Kayachikitsa, Department of Kayachikitsa
4. Head-Pharmacology
Laboratory, SDM College of Ayurveda, Udupi
*Corresponding Author: Deole Yogesh, Lecturer,
Department of Kayachikitsa, GJ Patel Institute of
Ayurvedic Studies and Research, New Vallabh Vidya Nagar, Gujarat, India.
E-Mail - dryogeshdeole@gmail.com;
Mob:
+91-9974999309
Abstract
Stress is the most hazardous
factor which can adversely affect the quality of life. Ayurvedic Rasayana formulations can be used to relieve stress and
there forth improve and maintain healthy quality of life. In the present study,
the effect of a classical ayurvedic Rasayana
formulation comprising three herbs Gokshura (Tribulus terrestris Linn.), Aamalaki (Emblica officinalis
Gaertn.)
and Guduchi (Tinospora cordifolia Miers.) is assessed on health, wellness and
quality of life questionnaire in stress prone patients. Total 108 patients complaining
of stress and decreased quality of life were randomly divided into two groups
of Rasayana
Ghana tablets (RGT) and Placebo group
(PG). The drug was given in a dose of two tablets of 500mg twice a day with
ghee and honey in unequal proportion. Result was assessed on the parameters
given in quality of life questionnaire. The
data was then analyzed by applying Wilcoxon non
parametric test in each group and chi-square test to compare efficacy in both
groups. RGT seems to be effective in decreasing the physical complaints and
improving mental/emotional state, adaptation to stress, life enjoyment and
overall quality of life to a significant level in each sub scale.
Key
words: Stress,
Quality of life, Rasayana, Gokshura (Tribulus terrestris Linn.), Aamalaki (Emblica officinalis
Gaertn.) , Guduchi (Tinospora cordifolia Miers.).
Introduction:
In today’s era of throat cutting competition, stress
is the inevitable factor of one’s life leading to various stress related disorders.
One can neither avoid stress nor stop functioning; Stress can disturb quality
of life in many ways. Recent researches show that stress
speeds the aging process by damaging the DNA.(1)
Another study showed that long-term stress may cause illness by declining
functions of immune system. Scientists have discovered stressful experiences
can boost production of chemicals that regulate the body's immune system. (2) Thus stress can
adversely affect quality of life of individual. This may be the reason that Charaka quoted Aayasa (stress)
as the foremost factor to be avoided (3).
But stress is the most
unavoidable factor in today’s daily life. The ailments are overruling mankind
and it is getting tougher for human being to fight against them. As described in Ayurveda, the healthy life
span is decreasing accordingly and that is all due to the ‘missing life style
management’. (4) So the world is distressed to fulfill all the goals of life in
this shortened healthy life span. This is the most hazardous effect of physical
and psychological stress. Dr. Hans Selye recognized
the mind-body connection involved with stress. He concluded that stress is
"the non-specific response of the body to any demand placed upon it."
Selye claims that it is not stress that harms us but
distress. Distress occurs when we prolong emotional stress and don't deal with
it in a positive manner. The body's response to stress is known as the ‘general
adaptation syndrome’. There are many different causes of stress that affect the
aging adult. These causes can produce a variety of responses that include both
physical and emotional effects. There are preventative measures that can be
taken to help reduce the effects of stress as well as different coping methods.
(5) Therefore
Ayurveda-the ancient wisdom and treatment modality bears the
responsibility to combat the problem to help ailing society through the nectar
on earth – Rasayana (rejuvenation).
Therefore a search was carried out to find potent ayurvedic
formulation with stress relieving properties. One such formulation
described is Rasayana Churna (powder) described by Vagbhata in Ashtanga Hridaya in Rasayana vidhi chapter ( A.Hr.
U. 39/ 159). It is the most profoundly used perfect combination of Gokshura (Tribulus terrestris
Linn.), Aamalaki (Emblica officinalis
Gaertn.)
and Guduchi (Tinospora cordifolia Miers.) as rasayana with its benefits for
maintaining sexual vigor, steadiness of body and mind, peacefulness, happiness
and longevity with black hairs.(6) In classics Vagbhata
has advocated the present Rasayana formulation in powder form. But considering the
disease stress, the psychology of stressed patients and the advantages of Ghana form like longer shelf life,
higher palatability and convenience to transport, it was decided to convert the
powder into Ghana form.
Aims
and Objectives:
The
present study was planned to evaluate the efficacy of Rasayana formulation in the form
of Rasayana
ghana
tablet (RGT) to improve the quality of life of stressed patients.
Materials
and Methods:
Drug:
The
Rasayana Ghana tablet was prepared in the pharmacy of
Gujarat Ayurved University, Jamnagar. Coarse powder
of all three herbs mentioned above was taken to prepare decoction and then
Ghana was made. The Ghana was further processed to prepare tablets from it.
Patients:
Patients
attending the O.P.D. and I.P.D. of department of Panchakarma and Manasa Roga, Institute
for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar
complaining of stress and fulfilling the criteria of inclusion were selected
for the present study. An elaborative case taking proforma
was specially prepared to evaluate the stress score and then to assess the
effect of RGT to improve the quality of life.
Inclusion Criteria: Patients between
the ages 16 to 60 years complaining of stress and decreased quality of life were
included.
Exclusion Criteria: Patients with
age less than 16 & above 60 years suffering from serious systemic diseases and
stress due to any other cause were excluded from the study.
Study Design: It was
a placebo controlled randomized prospective clinical study. Informed consent
was taken from the patient before including them in the trial. The study
protocol was approved by the institutional ethical committee. The method was
interrogation about the points in stress rating scale and health wellness
questionnaire. The subjects were asked to answer the question instantly without
thinking much in order to avoid bias and the early response was noted. The
subjects were free to withdraw themselves from clinical study at any given
point of time and were assured to keep the information confidential. The data
was recorded and further analyzed with suitable statistical tests.
Management and Grouping:
Selected
patients were randomly divided into two groups. All of them are given Haritaki Churna (powder of Terminalia chebula) in a dose of 5 g once a day for 3 consecutive
days with luke warm water in early morning for Koshtha & Srotas Shuddhi
before starting the medication.
§ Group I (RGT) : Rasayana Ghana tablet, two tablets of 500 mg,
two times a day
§ Group II (PG) : Placebo tablet with identical size etc. two tablets of
500 mg, two times a day
§ Sevana kala (Time): Early morning and in the evening
§ Duration : Two months
§ Anupana (Vehicle) : Cow’s ghee and honey in
unequal(2:1) proportion as mentioned in classics.
Criteria for Assessment: Quality of Life assessment scale was applied to appraise the improved
quality of life by the effect of therapy.
Psychological counseling was
done for all patients in both the groups.
Statistical analysis: The
information gathered on the basis of above observations was subjected to
statistical analysis. Wilcoxon signed rank test was
applied to evaluate the effect of therapy in each group. Chi square test was applied
to compare the efficacy in both groups. The results were interpreted at p<0.05,
p<0.01 and p<0.001 significance levels. The value of P<0.01 was
considered significant and the P < 0.001 was considered as highly significant.
Health, Wellness
& Quality of Life Questionnaire:
The quality of life questionnaire (7) comprising six subscales was adopted for the assessment
of effect of therapy. The method was interrogation and the responses were
recorded in the proforma, scores were calculated and
subjected to statistical analysis. The detail questions in each sub-scale are
enlisted in tables in the observation and results section. The scoring pattern
is given below.
I. Physical State : Rate the questions with respect to frequency:
Scoring :Never : 1 Rarely : 2
Occasionally : 3 Regularly : 4
Constantly : 5
II.
Mental/Emotional State: Rate the questions with respect to frequency:
Scoring: Never: 1 Rarely: 2 Occasionally
: 3 Regularly : 4 Constantly :
5
III. Stress
Evaluation: Evaluate
stress relative to the following:
Scoring : None : 1, Slight: 2,
Moderate: 3, Pronounced: 4,
Extensive: 5
IV. Life Enjoyment:
Rate on a degree scale of 1-5:
Scoring :Not at all: 1;
Slight:2;Moderate:3;Considerable:4; Extensive:5.
V. Overall Quality
of Life: Evaluate the feelings relative
to the quality of life:
Scoring :Terrible:1; Unhappy:2;
Mostly Dissatisfied:3; Mixed:4; Mostly Satisfied:5; Pleased:6; Delighted:7.
VI. Overall
Impressions:
Scoring : Better: 1; Same:2; Worse:3
The answer of each of the question in overall impression was
noted with respect to when the person first came to office.
Observations
and Results
Total 108 patients were registered for
the present study with 56 in group RGT and 52 in group PG. Among them, total 70
i.e. 36 in RGT group and 34 in placebo group completed treatment. Maximum patients
(39.81%) were in the age group of 31 to 40 years and were males (57.40%). The
results are shown in Tables 1 to 5.
Table
1: Effect of therapy on physical state :
Complaints |
RGT group |
PG |
χ2 |
P |
||||||
|
n |
% of imp. |
W |
PR |
n |
% of imp. |
W |
Pp |
||
1.
Presence of physical pain (neck/back ache, sore arms/legs, etc.). |
35 |
31.85 |
561 |
<0.01 |
33 |
12.97 |
136.00 |
<0.01 |
23.31 |
<0.001 |
2. Feeling of tension or stiffness
or lack of flexibility in your spine. |
35 |
31.34 |
528 |
<0.01 |
33 |
14.50 |
171.00 |
<0.01 |
23.31 |
<0.001 |
3. Incidence of fatigue or low
energy. |
35 |
35.66 |
630 |
<0.01 |
33 |
17.29 |
253.00 |
<0.01 |
17.84 |
<0.001 |
4. Incidence of colds and flu. |
35 |
24.00 |
153 |
<0.01 |
33 |
10.41 |
45.00 |
<0.05 |
30.08 |
<0.001 |
5. Incidence of headaches (of any
kind). |
35 |
25.68 |
253 |
<0.01 |
33 |
13.67 |
120.00 |
<0.01 |
35.52 |
<0.001 |
6. Incidence of nausea or
constipation. |
35 |
34.12 |
496 |
<0.01 |
33 |
14.84 |
171.00 |
<0.01 |
16.65 |
<0.001 |
7. Incidence of menstrual
discomfort. |
10 |
11.53 |
6 |
>0.05 |
11 |
9.09 |
6.00 |
<0.5 |
00 |
-- |
8. Incidence of allergies or skin
rashes. |
32 |
10.76 |
21 |
<0.05 |
32 |
10.00 |
28.00 |
<0.05 |
65.52 |
<0.001 |
9. Incidence of dizziness or
light-headedness. |
34 |
15.49 |
66 |
<0.01 |
33 |
7.92 |
28 |
<0.05 |
63.34 |
<0.001 |
10. Incidence of accidents or near
accidents or falling or tripping. |
34 |
6.77 |
10 |
<0.5 |
33 |
7.77 |
21.00 |
<0.05 |
81.51 |
<0.001 |
RGT: Rasayana Ghan tablet,PG: Placebo group, % of
imp: percentage of improvement ,W: Wilcoxon’s
value, PR: P value of Wilcoxon’s test in RGT group, Pp: P value of Wilcoxon’s test in PG group, χ2 :Chi square
value, P : P value of Chie square test
Table
2: Effect of therapy on Mental/Emotional
State:
Complaints |
RGT group |
PG |
χ2 |
P |
||||||
|
n |
% of imp. |
W |
PR |
n |
% of imp. |
W |
Pp |
||
1. If pain is present, how
distressed are you about it? |
35 |
33.09 |
630 |
<0.01 |
33 |
18.79 |
300.00 |
<0.01 |
26.21 |
<0.001 |
2. Presence of negative or
critical feelings about your self. |
35 |
34.28 |
630 |
<0.01 |
33 |
17.29 |
253.00 |
<0.01 |
26.21 |
<0.001 |
3. Experience of moodiness or
temper or angry outbursts. |
35 |
32.82 |
595 |
<0.01 |
33 |
17.55 |
253.00 |
<0.01 |
26.21 |
<0.001 |
4. Experience of depression or
lack of interest. |
35 |
34.05 |
630 |
<0.01 |
33 |
17.55 |
253.00 |
<0.01 |
23.31 |
<0.001 |
5. Being overly worried about
small things. |
35 |
33.08 |
595 |
<0.01 |
33 |
16.03 |
210.00 |
<0.01 |
26.21 |
<0.001 |
6. Difficulty thinking or
concentrating or indecisiveness. |
35 |
35.00 |
595 |
<0.01 |
33 |
16.03 |
210 |
<0.01 |
21.07 |
<0.001 |
7. Experience of vague fears or
anxiety. |
35 |
36.17 |
595 |
<0.01 |
33 |
16.03 |
210 |
<0.01 |
17.84 |
<0.001 |
8. Being fidgety or restless;
difficulty sitting still. |
35 |
32.35 |
496 |
<0.01 |
33 |
15.26 |
190.00 |
<0.01 |
26.21 |
<0.001 |
9. Difficulty falling or staying
asleep. |
35 |
31.81 |
496 |
<0.01 |
33 |
15.26 |
190.00 |
<0.01 |
23.31 |
<0.001 |
10. Experience of recurring
thoughts or dreams. |
35 |
31.57 |
465 |
<0.01 |
33 |
16.03 |
210 |
<0.01 |
23.31 |
<0.001 |
Table
3: Effect of therapy on Stress
evaluation:
Complaints |
RGT group |
PG |
χ2 |
P |
||||||
|
n |
% of imp. |
W |
PR |
n |
% of imp. |
W |
Pp |
||
1. Family. |
35 |
23.72 |
300 |
<0.01 |
33 |
5.35 |
15.00 |
<0.5 |
59.25 |
<0.001 |
2. Significant Relationship. |
35 |
24.56 |
300 |
<0.01 |
33 |
7.27 |
36.00 |
<0.05 |
57.39 |
<0.001 |
3. Health. |
35 |
33.57 |
630 |
<0.01 |
33 |
10.44 |
105.00 |
<0.01 |
24.10 |
<0.001 |
4. Finances. |
35 |
22.31 |
276 |
<0.01 |
33 |
3.22 |
10.00 |
<0.5 |
27.34 |
<0.001 |
5. Sex Life. |
28 |
24.11 |
171 |
<0.01 |
27 |
6.81 |
21.00 |
<0.05 |
134.38 |
<0.001 |
6. Work. |
35 |
34.01 |
435 |
<0.01 |
27 |
16.10 |
171.00 |
<0.01 |
29.26 |
<0.001 |
7. School |
03 |
18.18 |
3 |
<0.5 |
00 |
00 |
00 |
00 |
00 |
-- |
8. General well-being. |
35 |
36.61 |
630 |
<0.01 |
33 |
15.90 |
210.00 |
<0.01 |
19.29 |
<0.001 |
9. Emotional well-being. |
35 |
37.32 |
630 |
<0.01 |
33 |
14.50 |
171.00 |
<0.01 |
17.84 |
<0.001 |
10. Coping with daily problems. |
35 |
37.76 |
630 |
<0.01 |
33 |
12.97 |
153.00 |
<0.01 |
17.84 |
<0.001 |
Table
4: Effect of therapy on Life Enjoyment:
Complaints |
RGT group |
PG |
χ2 |
P |
||||||
|
n |
% of imp. |
W |
PR |
n |
% of imp. |
W |
Pp |
||
1. Openness to guidance to your
"inner voice/feelings |
35 |
↑47.12 |
-506 |
<0.01 |
33 |
↑30.12 |
-231.00 |
<0.01 |
11.68 |
<0.001 |
2. Experience of relaxation or
ease or well-being |
35 |
↑66.26 |
-630 |
<0.01 |
33 |
↑36.14 |
-300.00 |
<0.01 |
12.31 |
<0.001 |
3. Presence of positive feelings
about yourself |
35 |
↑65.47 |
-630 |
<0.01 |
33 |
↑33.33 |
-300.00 |
<0.01 |
11.05 |
<0.001 |
4. Interest in maintaining a
healthy lifestyle (e.g., diet, fitness, etc) |
35 |
↑64.28 |
-630 |
<0.01 |
33 |
↑32.14 |
-300.00 |
<0.01 |
11.33 |
<0.001 |
5. Feeling of being open and
aware/connected when relating to others |
35 |
↑60.00 |
-595 |
<0.01 |
33 |
↑30.95 |
-276.00 |
<0.01 |
11.65 |
<0.001 |
6. Level of confidence in your
ability to deal with adversity |
35 |
↑65.06 |
-630 |
<0.01 |
33 |
↑33.73 |
-300.00 |
<0.01 |
11.33 |
<0.001 |
7. Level of compassion for, and
acceptance of, others |
35 |
↑65.06 |
-630 |
<0.01 |
33 |
↑32.53 |
-276.00 |
<0.01 |
11.05 |
<0.001 |
8. Satisfaction with the level of
recreation in your life |
35 |
↑61.90 |
-595 |
<0.01 |
33 |
↑32.53 |
-276.00 |
<0.01 |
11.05 |
<0.001 |
9. Incidence of feelings of joy or
happiness |
35 |
↑61.90 |
-595 |
<0.01 |
33 |
↑34.14 |
-276.00 |
<0.01 |
12.56 |
<0.001 |
10. Level of satisfaction with your
sex life |
31 |
↑54.92 |
-378 |
<0.01 |
29 |
↑32.39 |
-190.00 |
<0.01 |
17.67 |
<0.001 |
11. Time devoted to things you
enjoy |
35 |
↑58.02 |
-496 |
<0.01 |
33 |
↑29.76 |
-253 |
<0.01 |
12.02 |
<0.001 |
↑
-Increase
Table
5: Effect of therapy on overall QOL:
Complaints |
RGT group |
PG |
χ2 |
P |
||||||
|
n |
% of imp. |
W |
PR |
n |
% of imp. |
W |
Pp |
||
1. Your personal life. |
35 |
↑41.32 |
-561.00 |
<0.01 |
33 |
↑14.65 |
-153.00 |
<0.01 |
84.78 |
<0.001 |
2.Your wife/husband or "significant other |
35 |
↑38.01 |
-496.00 |
<0.01 |
33 |
↑12.93 |
-120.00 |
<0.01 |
57.39 |
<0.001 |
3.Your romantic life. |
32 |
↑36.69 |
-435.00 |
<0.01 |
28 |
↑13.40 |
-91.00 |
<0.01 |
63.34 |
<0.001 |
4. Your job. |
32 |
↑49.50 |
-406.00 |
<0.01 |
25 |
↑23.68 |
-120.00 |
<0.01 |
27.97 |
<0.001 |
5. Your co-workers. |
31 |
↑51.04 |
-435.00 |
<0.01 |
25 |
↑23.37 |
-136.00 |
<0.01 |
41.15 |
<0.001 |
6. The actual work you do. |
33 |
↑49.52 |
-465.00 |
<0.01 |
25 |
↑23.68 |
-136.00 |
<0.01 |
43.82 |
<0.001 |
7. The handling of problems in your life. |
35 |
↑49.10 |
-528.00 |
<0.01 |
33 |
↑21.15 |
-210.00 |
<0.01 |
30.08 |
<0.001 |
8. What you are actually accomplishing in your life. |
35 |
↑48.67 |
-528.00 |
<0.01 |
33 |
↑18.69 |
-190.00 |
<0.01 |
43.71 |
<0.001 |
9. Your physical appearance - the way you look to others. |
35 |
↑43.47 |
-496.00 |
<0.01 |
33 |
↑19.62 |
-190.00 |
<0.01 |
43.71 |
<0.001 |
10. Your self. |
35 |
↑47.32 |
-561.00 |
<0.01 |
33 |
↑21.69 |
-210.00 |
<0.01 |
43.71 |
<0.001 |
11. Your ability to adjust to change in your life. |
35 |
↑47.36 |
-561.00 |
<0.01 |
33 |
↑21.49 |
-231.00 |
<0.01 |
57.39 |
<0.001 |
12. Your life as a whole. |
35 |
↑46.90 |
-528.00 |
<0.01 |
33 |
↑21.49 |
-231.00 |
<0.01 |
57.39 |
<0.001 |
13.Overall contentment with your life. |
35 |
↑45.21 |
-561.00 |
<0.01 |
33 |
↑22.64 |
-231.00 |
<0.01 |
43.71 |
<0.001 |
14. The extent to which your life has been as you want it. |
35 |
↑47.36 |
-561.00 |
<0.01 |
33 |
↑21.49 |
-231.00 |
<0.01 |
57.39 |
<0.001 |
Table
6: Effect of therapy on overall
impression by RGT and PG:
Impression |
RGT(% patients) |
PG(% patients) |
χ2 |
P |
||||
Better |
Same |
Worse |
Better |
Same |
Worse |
|||
1. Overall
my physical well-being is: |
91.42 |
8.57 |
0.00 |
48.48 |
51.51 |
0.00 |
11.65 |
<0.001 |
2. Overall
my mental/emotional state is: |
91.42 |
8.57 |
0.00 |
66.66 |
33.33 |
0.00 |
14.80 |
<0.001 |
3. Overall
my ability to handle stress is: |
97.14 |
2.85 |
0.00 |
66.66 |
33.33 |
0.00 |
17.84 |
<0.001 |
4. Overall
my enjoyment of life is: |
91.42 |
8.57 |
0.00 |
66.66 |
33.33 |
0.00 |
14.80 |
<0.001 |
5. Overall
my quality of life is: |
94.28 |
5.71 |
0.00 |
66.66 |
33.33 |
0.00 |
16.65 |
<0.001 |
Discussion
Improvement
in Physical State
As it is seen in introduction
stress can affect the body at various levels including gross to subtlest
levels; at systemic as well as cellular levels. Stress and parallel
pathological processes can cause huge damage to almost all cells of body. This
leads to gross decline in the physical state of the person. The quality of life
questionnaire enlists some of the major subjective declines in physical state. The
data (table 1) shows that RGT significantly improved almost all the physical
complaints related to quality of life. It can be seen
that placebo also decreased some of the physical complaints like physical pain,
tense feeling, fatigue, headache, nausea and constipation up to significant
level. The other parameters were not significantly affected. RGT showed good results over placebo in
physical state parameters in quality of life questionnaire and the effect was
statistically highly significant(p<0.001) in all the parameters. This may be
due to stress relieving properties of RGT.
Improvement in Mental/Emotional State
The data on
mental/emotional state illustrates that RGT significantly improved all the
aspects of mental state in quality of life questionnaire (table 2).The data indicates the
efficacy of placebo on mental/emotional state which was observed significant in
all aspects. But the effect was meager in terms of percentage. With respect to the effect on
mental/emotional state, it was observed that RGT showed statistically
significant (p<0.001) results in all the parameters. The effect again signifies the
psychotropic action of RGT. By the adaptogenic,
anti-stress, antidepressant, anxiolytic properties, RGT acted upon to relieve these complaints.
The little effect shown by placebo may be due to effect of vehicle ghee and
honey.
Improvement in Stress evaluation:
In the stress
evaluation related to quality of life, RGT improved almost all the responses to
stress in all aspects to a significant extent (table 3). Placebo also showed
positive significant response in some aspects like health, work, general well
being, emotional well being and coping with daily
problems. The other parameters were not relieved upto
significant mark. In the stress evaluation score, RGT showed nearly three times
greater effect than that of placebo in terms of percentage and the results were
highly significant (p<0.001) on applying chi square test. All these factors are worthy to
think about while dealing with the stressed patient. It a matter of fact that
one can’t avoid the day to day stress, but the reaction to stress can be
positively improved by taking adaptogenic drugs. The effect again points towards importance of RGT in
stress relief.
Improvement in Life Enjoyment:
One of the most
remarkable effect seen in this present study was that
shown by RGT in life enjoyment parameters of QoL. RGT
significantly improved the positive things about oneself in life enjoyment
parameters like openness
to guidance to one’s inner voice/feelings (47.12%), experience of relaxation or
ease or well-being (66.26%), presence of positive feelings about oneself
(65.47%), interest in maintaining a healthy lifestyle (e.g., diet, fitness,
etc) (64.28%), level of confidence in self ability to deal with adversity
(65.06%), level of satisfaction with one’s sex life (54.92%), Time devoted to
things you enjoy(58.02%) and satisfaction with the level of recreation in self
life (61.90%). It also empowered the positive social aspects of life such as
feeling of being open and aware/connected when relating to others (60%), level
of compassion for, and acceptance of others (65.06%), incidence of feelings of
joy or happiness (61.90%). All the
parameters were found improved by RGT twice that of placebo and the difference
was highly significant (p<0.001) (table 4). The effect of RGT on the
positive symptoms may be due to anti-depressant, anxiolytic
property of trial drug. The effect observed in symptoms related to social
responses may be due to anti-stress, adaptogenic
activity of RGT which first relieves stress and then produces relaxation and
joy in mind. This ultimately leads to increased endurance showing positive
exogenous response.
Improvement in overall QOL and overall
impression after treatment:
RGT showed better
significant effect in all the parameters included in overall quality of life
(table 5). Placebo also resulted in significant improvement in overall quality
of life parameters, but the result was nearly half than RGT in terms of
percentage. Highly significant (p<0.001) difference in the effect of RGT and
placebo on the parameters of overall quality of life was observed in terms of
percentage as well as statistics. In the last overall impression in quality of
life parameters maximum i.e. over 90% patients stated they had a better feeling
in all parameters by the treatment of RGT. When the difference between the RGT
effect and placebo was analyzed statistically, it was found highly significant
at the level of 0.001(table 6). The reasons behind the action are described in
the above paragraph. It can be easily inferred that as the stress increases,
the quality of life decreases to the hazardous physical and psychological
impact of stress. As the medicine and psychological counseling improves the adaptation
to stress, the quality of life tends to improve as it has been documented by
the above data.
Probable mode of action of drug:
As
stated in introductory part RGT is a tri herbal compound comprising of Tinospora cordifolia,
Emblica officinalis
and Tribulus terrestris.
Among these Tinospora cordifolia
is with proven stress-attenuating activity. (8) In addition, Tinospora cordifolia
is reported to show positive actions viz. adaptogenic(9,10) antioxidant(11,12,8) immunomodulatory(13-15),
anti-inflammatory(16) in experimental animals . It is also known to possess
beneficial effects on learning, stress and memory. (17) Tinospora
was also found to possess protective effect against lead induced hepatotoxicity through moderate anti-oxidant activity. (18)
On a whole the possibility of RGT acting through correcting the psycho-neuro-endocrinal axis (hypothalamo-
pituitary axis) can not be denied. Many reports have proved that Emblica officinalis is
having immunomodulatory activity, adoptogenic
and antioxidant activity. (19-26) Earlier studies on
formulation containing Guduchi
(Guduchyadi ghrita) and Aamalaki (Bhringarajadi rasayana)
showed potent antidepressant, anti stress, anxiolytic
activity. (27) The studies on Tribulus terrestris (Gokshuru) suggest that the Harmine
content of Tribulus
acts as Monoamine Oxidase (MAO) inhibitor, leading to
higher levels of dopamine in the brain. Due to higher levels of dopamine, the
mood is elevated slowly and the stronger and better is the feeling. (28) Further
honey (29-31) and ghee(32) are also proven for their
anti-oxidant and adaptogenic activities. Thus the observed and anxiolytic
and anti-depressant profile of RGT may be attributed to one or more
bioactive principles present in these drugs. There may be synergetic herb-herb
interactions enhancing the total efficacy of the formulation. RGT has showed
significant anti-oxidant and anti-stress activity in experimental animals. (33)
The exact mechanism action of the drug needs to be evaluated by further extensive
studies.
The cumulative properties of RGT include Madhura rasa (sweet taste), Tikta rasa (bitter taste), Madhura Vipaka, Sheeta Virya, Guru , Snigdha ,Yogavahi guna, Medhya Rasayana and Tridosha shamaka properties. The pharmacokinetic mode of action is
shown in table below:
Property of
RGT formulation |
Beneficial
effects to relieve stress and improve quality of life |
Benefit |
Madhura rasa |
Vata Pitta shamaka and Kapha vardhaka Sharira satmya (compatible
to body), Sapta dhatu and Oja vivardhaka, Aayushya (increasing longevity), Shad indriya prasadano (
creates happiness in all sense organs including mind) , bala-varna karah (improves strength and
complexion), alleviates Pitta, Visha, Vata, Trishna, Daha, also having Twachya, Keshya, Kanthya
(improves skin texture, hair quality and voice quality) , Preenana ( instantly nourishing), Jeevana (improving
quality of life), Tarpana
(nurtures), Brimhana, Sthairyakarah,
Jivha pralhadano. (34) At psychic level, Sattva enhancing activity, due to snigdha, sthira qualities. (35) It can reduce Rajas. |
-Relieves stress at physical and psychic level -Improves adaptation -Can provide overall energy, nourishment and stability to the tissues |
Madhura Vipaka |
Promotes
normal Kapha, pacifies Vata and Pitta dosha,
promotes semen and helps in proper elimination of stool and urine. (36) Leads to Aalhada i.e. soothening and delightfulness. (37) Can produce Soumanasya
(sense of well being), Bala
(power), Utsaha
(enthusiasm), Harshana (pleasure), Sukham (happiness). (38) |
Important
qualities to alleviate stress and its adverse psychological signs. Can potentiate
the activities of Madhura rasa as mentioned above. |
Sheeta Virya |
At psychic
level, Sheeta
can produce Lhadana (delightenining of mind) (39), At physical
level it can aggravate Kapha - Vata and pacifies Pitta dosha. (40) |
Soothening
and calming effect necessary for relaxation of mind in stress.Sedative
property may be helpful to relieve agitation and anxiety. |
Guru and Snigdha guna |
Can pacify Vata
and promote Kapha. Can show Dhatu vriddhi, snehana and brimhana actions. (41) |
Guru can
lead to sthairya
(stability), greater adaptation capacity, promote proper sleep and provide
nourishment to prevent degeneration due to stress. On body tissues, Snigdha guna shows
nourishing effect, with snehana and brimhana actions. |
Medhya Rasayana |
Due to Guduchi . (42) Goghrita is known to facilitate all the three mental
faculties Dhi
(intellect), Dhriti
(retention), and Smriti
(memory). |
Helps to regain and restore positive
mental health in stress. |
Dosha Shamaka properties |
Tridosha shamaka (predominance
in Vata-Pitta Shamana and
Kapha vardhan
activity) |
Re establish Samya avastha
(homeostasis) (43) by pacifying the Vata and Pitta dosha vitiated in stress and also increase Kapha depleted due to stress. |
Thus Rasayana Ghana tablet can be useful in treating the stress related
disorders as well as to improve and maintain quality of life in the era of
competition.
Conclusion
From
the above data, it can be concluded that Rasayana formulation was
effective in decreasing the physical complaints related to quality of life,
improving the mental and emotional state, decreasing stress evaluation score in
various aspects of life, increasing life enjoyment parameters and thus overall
quality of life. It can be easily inferred that as the stress increases, the
quality of life decreases to the hazardous physical and psychological impact of
stress. As the medicine Rasayana Ghana tablet improves the adaptation to
stress, the quality of life tends to improve as it has been documented by the
above data.
Acknowledgement
The
authors acknowledge Prof.M.S.Baghel, Director-I.P.G.T.& R.A. for inspirational support. The authors express
thanks to Dr. Swapnil Auti
for assistance in statistical analysis of the data.
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