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A CLINICAL STUDY TO EVALUATE THE BOWEL REGULATORY POTENTIAL OF SHRIPHALADI KHANDA-AN AYURVEDIC FORMULATION

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  • Babe ke Ayurvedic Medical College & Hospital

Abstract and Figures

Lifestyle of humans has changed substantially in this modernized world. Technology has given easy access to almost everything under our fingers, but has led to reduced physical activity leading to increased incidence of lifestyle related disorders. Recent trends have shown people taking high amount of calories from animal products, sugars, fats & refined food items. Consumption of fibers in the diet has reduced. Young generation is more into the habit of junk food. Further level of stress has increased both at personal and professional life. All these factors are having ill effects on every organ system of body. Due to these lifestyle changes gastrointestinal symptoms like constipation, heartburn, abdominal discomfort & diarrhea are frequently encountered in clinical practice. Constipation is a common prevalent problem in general population with prevalence 2-28%. Constipation is associated with significantly impaired quality of life and psychological distress, as well as increased health care costs and impaired work productivity. Constipation has been defined as a frequency of defecation less than three times per week with subjective complaints of excessive straining, hard stools, lower abdominal fullness and a sense of incomplete evacuation. Different classes of laxatives have various limitations in one or another form. Hence present study was planned to evaluate the bowel regulatory potential of a herbal formulation Shriphaladi khanda. The trial drug was found to be an effective, clinically safe and non habit forming herbal formulation with good palatability.
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Upadhyay et al. UJAHM 2015, 03 (01): Page 24-29
Unique Journal of Ayurvedic and Herbal Medicines, 03 (01), Jan-Feb 2015 24
U
NIQUE
J
OURNAL OF
A
YURVEDIC AND
H
ERBAL
M
EDICINES
Available online: www.ujconline.net
Research
Article
ISSN 2347
-
2375
A CLINICAL STUDY TO EVALUATE THE BOWEL REGULATORY POTENTIAL
OF SHRIPHALADI KHANDA-AN AYURVEDIC FORMULATION
Upadhyay Abhishek
1*
, Vaidya Meghna
2
, Sharma YK
3
, Manglesh Rajesh
4
1
Lecturer, Department of Kayachikitsa, Babe Ke Ayurvedic Medical College & Hospital Daudhar, Moga, Punjab, India
2
Lecturer, Department of Ras Shastra & Bhaishajya Kalpana, Babe Ke Ayurvedic Medical College & Hospital Daudhar, Moga, India
3
Principal, Rajiv Gandhi Govt. Post Graduate Ayurvedic College Paprola, H.P, India
4
Reader, Department of Rog Nidan, Rajiv Gandhi Govt. Post Graduate Ayurvedic College Paprola, H.P, India
Received 17-12-2014; Revised 16-01-2015; Accepted 13-02-2015
*Corresponding Author: Abhishek Upadhyay,
Lecturer, Department of Kayachikitsa,
Babe Ke Ayurvedic Medical College & Hospital Daudhar, Moga, Punjab. Contact- 9915613039
ABSTRACT
Lifestyle of humans has changed substantially in this modernized world. Technology has given easy access to almost everything under
our fingers, but has led to reduced physical activity leading to increased incidence of lifestyle related disorders. Recent trends have
shown people taking high amount of calories from animal products, sugars, fats & refined food items. Consumption of fibers in the
diet has reduced. Young generation is more into the habit of junk food. Further level of stress has increased both at personal and
professional life. All these factors are having ill effects on every organ system of body. Due to these lifestyle changes gastrointestinal
symptoms like constipation, heartburn, abdominal discomfort & diarrhea are frequently encountered in clinical practice. Constipation
is a common prevalent problem in general population with prevalence 2-28%. Constipation is associated with significantly impaired
quality of life and psychological distress, as well as increased health care costs and impaired work productivity. Constipation has been
defined as a frequency of defecation less than three times per week with subjective complaints of excessive straining, hard stools,
lower abdominal fullness and a sense of incomplete evacuation. Different classes of laxatives have various limitations in one or
another form. Hence present study was planned to evaluate the bowel regulatory potential of a herbal formulation Shriphaladi khanda.
The trial drug was found to be an effective, clinically safe and non habit forming herbal formulation with good palatability.
Keywords: Constipation, Laxative, Herbal, Bilva, Cassia fistula, Gastrointestinal symptom.
INTRODUCTION
In today’s fast moving world, life style of mankind has
changed substantially and it is now hard to keep up with the
pace of life. Major factors which have changed our lifestyle
are technological advancements, faulty dietary habits, reduced
physical activity and stress. Workplaces are now equipped
with computers and automated machines. Sporting activities
have been reduced, young generation is more interested in
videogames as compared to outdoor games. People’s dietary
habits have changed substantially with increase in
consumption of animal products, milk and milk products,
sugars, fats, oils and alcoholic beverages. People are more into
the habit of junk and spicy food. Fiber in the diet has reduced
a lot.
1
Stress has become an inescapable part of modern life.
These life style changes have impact on every organ system of
human body in some or other way. That’s why the incidence
of life style disorders such as hypertension, diabetes, obesity,
heart diseases and constipation etc. is on rise. Like any other
system the digestive system is also sensitive to changing life
style and it can be easily disrupted by a poor diet, lack of fluid,
too little exercise, absence of routine and high level of stress.
2
The digestive system releases the fuel we need to lead our
lives and dispose off the waste that is left. Ensuring it remains
free flowing plays an essential part in achieving inner health.
Almost one third of the general population have some form of
bowel problems varying from heartburn and abdominal
discomfort, to constipation and diarrhea.
3
Constipation is one
of the most common gastrointestinal disorders encountered in
patients visiting to the medical OPD. Most studies estimate the
prevalence of constipation in general population to be 2-28%.
The prevalence increases with age and is more frequent in
females.
4
It is believed that India is having lesser prevalence
of constipation in comparison to more developed Asian and
Western nations, but still patient number is large. A study
involving 4,767 participants from rural areas in the northern
Upadhyay et al. UJAHM 2015, 03 (01): Page 24-29
Unique Journal of Ayurvedic and Herbal Medicines, 03 (01), Jan-Feb 2015 25
part of India has found the prevalence of constipation 11%,
which if translated into real numbers, it is estimated that
around 130 million Indians are suffering from constipation
3
.
Constipation is both a symptom and when chronic, a multi
symptom disorder which can overlap with other GIT disorders
such as dyspepsia and GERD
5
. Discrepancies in the
population prevalence of constipation have been attributed to
the lack of uniform diagnostic criteria and the number of
patients who seek medical care. Constipation is associated
with significantly impaired quality of life and psychological
distress, as well as increased health care costs and impaired
work productivity
3
. Although it is not a life threatening
problem, even then it causes great distress to those afflicted
and can be difficult to cure. Constipation is change in bowel
habits, when one goes to toilet less often than usual for him.
There is wide range of normal bowel habits in different
populations and it can range from three times a day to three
times a week. Constipation has been defined as a frequency of
defecation less than three times per week with subjective
complaints of excessive straining, hard stools, lower
abdominal fullness and a sense of incomplete evacuation.
6
Although this disease has not been described in classical texts
of ayurveda as a separate disease entity, but its description is
available in almost every text as a prodromal symptom, sign or
complication of various diseases. It has been described at
different places using various nomenclatures signifying the
same meaning. Different classes of laxatives used for the
treatment of constipation has various limitations in one or
other form due to the latency period of action, habit forming
nature or due to adverse effects of the drugs
7
. Various herbal
formulations are also available for the treatment of
constipation which are non-habit forming but palatability is
the limiting factor for their use. Present study was planned to
formulate an effective, safe, non habit forming, cost effective,
and palatable herbal remedy for constipation. Keeping all
these facts in mind trial drug Shriphaladi khanda was selected
for the trial which is an anubhuta yoga having Bilwa (Aegle
marmelos), Amaltas (Cassia fistula), Saunf (Foeniculum
vulgare) and Guda (Jaggery) prepared in the form of granules.
MATERIALS AND METHODS
Selection of the patients
The current study was open clinical trial carried out on a
single group. 23 patients fulfilling the inclusion criteria were
selected randomly after their voluntary informed consent
irrespective of their sex, caste, religion, education etc.
Criteria for selection of patients
Inclusion Criteria
1. Patients willing for the trial
2. Patients in age group between 18-60 years
3. Patients of habitual constipation
4. No associated chronic ailment
Exclusion Criteria
1. Haemorrhoids (3
rd
and 4
th
degree), Anal strictures &
Rectal prolapse
2. Intestinal obstruction & Perforation
3. Diabetes & Diabetic enteropathy.
4. Diarrhoea
5. Pregnant women
6. Different types of hernia
7. Carcinoma (Malignancies)
8. Patients showing any allergy to trial drug
9. Any other thought fit for exclusion
Protocol of Research
Institutional Ethics committee approval was taken before
conducting the clinical trial.
Consent of Patient
Written informed consent of every selected patient for the trial
was taken after explaining the nature of the study including
merits and demerits.
Clinical Research Form
Detailed information of every patient including complete
demographic profile of patient, chief complaints with duration,
family history, personal history, socio-economic history,
general physical examination, systemic examination along
with ashtavidha pariksha, dashvidha pariksha and srotas
examination was recorded in the clinical research form.
Trial drug and its Ingredients
The selected patients were given the trial drug “Shriphaladi
khanda”. The drug was named so using synonym of Bilva i.e.
Shriphal. The drug was prepared using following ingredients.
1. Pakva Bilva Majja Churna (Pulp of ripe fruit of Aegle
marmelos) - 3 parts
2. Amaltas Phala Majja (Pulp of pod of Cassia fistu)- 2 parts
3. Shatpushpa (Saunf) (Fruits of Foeniculum vulgare) -1 part
4. Guda (Jaggery) - Q.S.
Preparation of Drug
The different ingredients of the trial drug were got identified
by dravya guna department of the college. Trial drug was
prepared in the form of granules by using guda as binding
agent. The drug was prepared in the college pharmacy under
the supervision of in-charge of the pharmacy.
Administration and Dose of Drug
Administration - Orally after meals
Dose - 10gm BD
Anupana - Luke warm water.
Duration of the trial & Follow-up
The total duration of the trial was of 15 days. The patients
were advised to come for follow up after 7 days of initiation of
trial and at the end of trial to observe the effects and adverse
effects of trial drug.
Criteria of Assessment
Assessment was done on the basis of relief in signs and
symptoms. Total eleven criterias were selected for assessment.
Scoring system was adopted for statistical analysis of results
obtained. Each criteria was assigned four grades ranging from
0-3 depending upon the severity of the symptom. Criterias
selected for the trial were consistency of stool, discomfort in
abdomen, pain in abdomen, bloating in abdomen, painful
bowel movement, rectal bleeding or tearing during bowel
movement, satisfaction after bowel movement, straining,
squeezing or manual maneuvers to pass bowel, number of
visits to toilet, average time spent in toilet per visit and visual
analogue scale.
Statistical Analysis
The information gathered regarding demographic data is
shown in terms of percentage. The scores of criteria of
Upadhyay et al. UJAHM 2015, 03 (01): Page 24-29
Unique Journal of Ayurvedic and Herbal Medicines, 03 (01), Jan-Feb 2015 26
assessment were analyzed statistically in terms of mean score
B.T. (Before treatment), A.T. (After treatment), (B.T. A.T.)
difference of mean, S.D. (Standard deviation), S.E. (Standard
error). Student’s paired ‘t’ test was carried out at p<0.05 and
p<0.001.
The results were considered significant or insignificant
depending upon the value of p.
Highly significant - p<0.001
Significant - p<0.05
Insignificant - p>0.05
Overall results were established in terms of percentage relief
obtained in criterias of assessment.
Cured - 100%
Excellent improvement - 75-99%
Moderate Improvement - 50-74%
Mild Improvement - 25-49%
No improvement - 0-24%
OBSERVATIONS
In the present study, total 23 patients were registered out of
which one patient did not turn up for follow up and was
considered dropout hence statistical analysis of results were
carried out on 22 patients. It was observed during the trial that
maximum number of patients i.e. 43.48% (10) were between
51-60 years of the age, 52.17% (12) patients were males,
91.30% (21) were of Hindu religion, 30.44% (7) of the
patients were farmers, 39.13% (9) of the patients were
illiterate, 82.61% (19) were married, 60.87% (14) were of
middle class, 56.52% (13) patients had no addiction, 52.17%
(12) of the patients were of vata-pittaj prakriti, 78.26% (18)
were having krura koshtha, 91.30% (21) were from rural area,
60.87% (14) of the patients were having mixed dietary habits,
60.87% (14) of the patients were having normal appetite,
73.91% (17) were having irregular bowel habits, 56.52% (13)
of the patients had moderately active lifestyle, 86.96% (20) of
the patients were of madhyama satva, 39.13% (9) of the
patients had chronicity of the disease for 3-6 months.
RESULTS
Effect of therapy was observed on the basis of relief in
criterias of assessment (Table 1). Statistically significant
results were obtained in consistency of stool with p<0.001.
There was marked improvement in discomfort in abdomen
with statistically significant value of p<0.001. Pain in
abdomen was relieved by 80.18% in terms of percentage but
statistically it was insignificant with p>0.05 due to small
sample size. Statistically significant improvement was seen in
bloating in abdomen with p<0.001. Painful bowel movement
also showed 100% improvement in terms of percentage but it
was statistically insignificant with p>0.05 again due to
presence of this symptom in lesser number of patients. Relief
in symptom of rectal bleeding or tearing during bowel
movement was statistically insignificant with p>0.05 due to
small sample size. Satisfaction after bowel movement was
improved with statistically significant value of p<0.001.
Symptom of straining, squeezing or manual maneuvers to pass
bowel showed significant improvement statistically with
p<0.001. Average number of visits to toilet after treatment
were once a day which was statistically significant with
p<0.05. With treatment average time spent in toilet per visit
was reduced which was significant statistically with p<0.001.
Overall feeling of well being was also assessed in the patients
with the help of visual analogue scale which showed
statistically significant results with p<0.001.
OVERALL EFFECT OF THERAPY
Overall effect of therapy was calculated on the basis of
percentage relief in signs and symptoms. Out of 22 patients
22.73% patients were completely cured i.e. they had no
symptom present at the end of study, 54.54% patients showed
excellent improvement and 22.73% patients showed moderate
improvement. There were no such patients who showed mild
improvement or were unimproved. Patients after completion
of trial were further observed for next 15 days for recurrence
of symptoms. None of the patient reported back with
complaint of constipation (Table 2).
Table 1: Effect of Therapy on Criterias of Assessment
Sl.
No Assessment Criteria N
Mean X (X
1
-
X
2
)
Percentage
Relief (%)
S.D.
+
S.E.
+ t p
BT
(X
1
)
AT
(X
2
)
I Consistency of Stool 22 1.59 0 1.59 100 0.74 0.16 9.94 <0.001
II Discomfort in abdomen 22 1.32 0.32 1.00 75.76 0.62 0.13 7.69 <0.001
III Pain in Abdomen 9 1.11 0.22 0.89 80.18 1.28 0.43 2.07 >0.05
IV Bloating in abdomen 19 1.53 0.74 0.79 51.63 0.53 0.12 6.58 <0.001
V Painful bowel movement 6 1.17 0 1.17 100 2.13 0.87 1.35 >0.05
VI Rectal bleeding or tearing during bowel
movement 3 1.00 0.33 0.67 67 2.15 1.24 0.54 >0.05
VII Satisfaction after bowel movement 22 2.27 0.59 1.68 74.01 0.71 0.15 11.2 <0.001
VIII Straining squeezing or Manual maneuvers
to pass bowel 21 1.62 0.29 1.33 82.10 0.65 0.14 9.5 <0.001
IX Number of visits to toilet per day 10 2 0 2 100 2.49 0.79 2.53 <0.05
X Average time spent in toilet per visit 16 1.13 0.25 0.88 77.88 0.74 0.19 4.63 <0.001
XI Visual Analogue Scale 22 1.45 0.05 1.40 96.55 0.67 0.14 10 <0.001
N: Number of patients; BT: Before treatment; AT: After treatment; X: Difference of mean;
S.D: Standard deviation; S.E: Standard Error
Upadhyay et al. UJAHM 2015, 03 (01): Page 24-29
Unique Journal of Ayurvedic and Herbal Medicines, 03 (01), Jan-Feb 2015 27
Table 2: Overall Effect of Therapy
Overall Effect of Therapy No. of patients % Relief
Cured 5 22.73
Excellent Improvement 12 54.54
Moderate Improvement 5 22.73
Mild Improvement 0 0
No Improvement 0 0
DISCUSSION
In the present clinical trial the most common presentation with
which the patients reported were hard consistency of stool
(100%), discomfort in abdomen (100%), reduced satisfaction
after bowel movement (100%), increased straining-squeezing
and using manual maneuvers to pass bowel (95.45%), bloating
in abdomen (86.36%), increased average time spent in toilet
per visit (72.73%) and reduced number of visits to toilet
(45.45%). Other important but less common presentations
were pain in abdomen (40.91%), painful bowel movements
(27.27%) and rectal bleeding or tearing during bowel
movements (13.64%). These symptoms are in accordance with
the symptoms often encountered in constipated subjects. It
was observed that relief in symptom of hard consistency of
stool was gradual and at the end of trial this symptom was
found to be completely relieved. Two patients also reported
with loose consistency of stool with frequency 2-3 times/day
after taking recommended trial drug dosage for few days.
Discomfort in abdomen occurs due to incomplete evacuation
of bowel and presence of gases in the intestinal lumen. The
effect of drug in improving the discomfort in abdomen was
due to its carminative and stomachic properties which are
described while describing the probable mode of action of
drug. Moreover as the bowel clearance gets better, discomfort
in abdomen also improves. Pain in abdomen occurs due to
pressure effects of impacted stool and intra luminal gases on
the intestinal wall. Severity of pain in abdomen is proportional
to the chronicity of constipation. With improvement in
consistency of stool, pain in abdomen also improves.
Improvement in pain in abdomen was also related to bowel
clearance and the stomachic and carminative properties of
fennel which is having proven antispasmodic effect. Fennel
seeds produce a reduction in acetylcholine and histamine
induced contractions and thus improve pain in abdomen.
Painful bowel movements occur due to hard consistency of
stool. Hard consistency of stool results into excessive straining
during defecation, which results into painful defecation.
Painful bowel movements can be due to associated anorectal
disorders viz. fissure-in-ano, haemorrhoids, and fistula-in-ano
etc., caused as a result of constipation. It was observed that
number of visits to toilet after taking treatment was once or
twice a day on an average. Average time spent in the toilet per
visit also got reduced as there was improvement in consistency
of stool.
PROBABLE MODE OF ACTION OF SHRIPHALADI
KHANDA
On the basis of Ayurvedic pharmacological properties
This formulation is made up of Pakva Bilva majja churna,
Amaltas phal majja, Saunf and Guda. These drugs are widely
described in classical texts. Amaltas and Pakwa Bilva are
described as mriduvirechaka
8,9
, whereas Satpushpa as
vibandhnashak and vatanulomaka
10
. From the pathogenesis of
constipation it is evident that apana vata is mainly vitiated and
is the main causative factor of this disease as excretion of stool
is function of apana vayu
11
. Due to various nidanas,
ruksha(dry), chala and sheet guna of vayu get vitiated causing
hardening of faeces. Therefore for the treatment of
vibandha(~constipation), criteria of drug selection should be
based on the gunas of the drugs which are able to pacify
vitiated sheeta, chala and ruksha gunas. Hence the drugs
which are snigdha, ushna, sthir and anulomaka should be
selected for the treatment of constipation. Mentioning the
properties of rechaka dravyas Charaka has described that
rechaka dravyas should be sarvarasa, ushna, tikshna, sukshma,
vyavayi and vikasi
12
. According to Sushruta rechak dravyas
should be guru in nature owing to their prithvi and jal bahul
constitution
13
. Due to this they have the potential to move
intestinal contents towards adhomarga. Pakva Bilva phal due
to its madhura rasa and guru guna,
14
have potential of
pacifying vata and moving the intestinal contents towards
rectum.
Amaltas is mentioned under virechana gana by Charak and
adhobhagahara dravya by Sushruta. It is madhura(~sweet) in
taste, with guru, mridu and snigdha properties, madhura vipaki
and sheeta virya. Due to madhura and snigdha guna it has
potential of pacifying vata dosha and has
anulomaka(~carminative) effect. Due to snigdha guna it also
softens the stool.
15
It has rechana effect due to prabhava and is
described as best mridurechana dravya by Charaka.
16
Saunf is vata shamaka due to its madhur and snigdha
properties. It has anulomana property which helps in
propagation of intestinal contents downwards. Being deepana
and pachana it has potential to remove amadosha associated
mala(~waste) and hence help in nirama-malapravriti.
17
Jaggery is used mainly to improve palatability of drug but it
also has emmolient and laxative effect due to its guru &
snighda properties.
18
Hence this formulation complies with all
the required properties of a rechana drug.
Probable mode of action on the basis of chemical
constituents
This blend is formulated as a medium strength laxative. All
the three drugs used in the formulation are having laxative
effect. Along with laxative effect formulation is also having
antispasmodic and carminative effect. This formulation as a
whole exhibits its laxative effect through mixed type of mode
of action. The ripe fruits of Bilva (Aegle marmelos) are
valuable for its rich nutritive, sweet, aromatic, cooling,
astringent, febrifuge, laxative and tonic properties. It is very
good for all kind of stomach disorders and helps in improving
appetite and digestion. It is a unique fruit which is famous as
laxative and at the same time as an intestinal astringent also.
19
The use of ripe fruits is highly efficacious in the case of
chronic constipation
9
, and where patients complain of
incomplete evacuation. The fruit pulp contains high amount of
moisture (60.7%), mucilage, pectin (2.52%), along with other
constituents. It is febrifuge and laxative due to its high
moisture, mucilage and pectin contents
19
. It probably works as
Upadhyay et al. UJAHM 2015, 03 (01): Page 24-29
Unique Journal of Ayurvedic and Herbal Medicines, 03 (01), Jan-Feb 2015 28
laxative through its stool softening as well as bulk forming
nature.
Amaltas (Cassia fistula) has been used as a highly effective,
mild laxative that is safe even for children, older persons and
in pregnancy.
20
Cassia is supposed to act as a stimulant and
bulk forming laxative. The purgative action of cassia is due to
the presence of Cathartic acid, Aloe emodine (Anthraquinone)
and Chrysophanic acid
21
. It is having a sufficient amount of
fiber content in the form of mucilage and pectin. Thus it acts
like a bulk forming laxative. Its action being chiefly on the
large bowel, it is especially suitable in habitual constiveness.
The fruit pulp of Cassia fistula is rich in Anthraquinone
derivatives e.g. rhein, sennidin and related dianthrones and
sennoside and related dianthrone glycosides which are
responsible for laxative properties. The sugar moiety in
glycosides increases water solubility of the molecules and thus
facilitates transport to the sie of action i.e. colon. They are
hydrolyzed in the colon by the β-glucosidase enzyme of the
intestinal flora to give free anthraquinones which are further
reduced to anthrones. The anthrones formed in-situ are the
active laxative form of anthroquinone compounds which affect
the intestinal motility and increase peristaltic movements of
the colon and sigmoid, by its local action upon the intestinal
wall
22
.
Fennel is a common herb used as a flavouring agent in many
herbal formulations for making their pallatability better. It
helps to promote good digestion and ease gas and bloating.
23
The major constituents of fennel include the terpenoid,
anethole, fenchone and other terpenoids, inhibit spasm in
smooth muscles of gastrointestinal tract and is thought to
contribute to fennel’s use as a carminative and stomachic.
Fennel traditionally has been used as an antiflatulent.
24
Fennel
seeds also contain fiber and complex carbohydrates. Fennel
seeds used in the form of powder, act as bulk forming
laxative.
25
Fiber content present in fennel seeds helps to clear
off the bowels. The stimulating effect of fennel seeds helps in
creating proper peristaltic movement of the intestine. This in
turn helps to improve a person’s digestive and excretory
systems. Fennel seeds increase gastro-intestinal motility and
act as antispasmodic at high doses. Fennel seeds produce
reduction in acetylcholine and histamine induced contraction
and decrease maximum possible contractility. Fennel seeds
have also shown prostaglandin and oxytocin inhibiting activity
in mice
26, 27
.
CONCLUSION
From the above observations and discussion, it can be
concluded that, this formulation as a whole is a good medium
strength laxative along with carminative and stomachic
properties. It exhibits its laxative action through mixed type of
effects on the intestinal wall and stool i.e. due to chemical
irritation (cathartic acid and anthraquinone derivatives),
through mechanical irritation (fiber content) and as stool
softener (due to moisture content and soothing effect of all the
three drugs). The drugs used in this formulation also help in
improving digestion and metabolism by their well known
effect at the level of agni (~digestive fire) thus targeting the
root cause of various gastrointestinal disorders.
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