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Website: www.ayujournal.org
DOI: 10.4103/0974-8520.127717

Clinical Research Quick Response Code:

Clinical evaluation of Bilvadileha in the management of

irritable bowel syndrome
Ramanand Tiwari, Darshana H. Pandya1, Madhav Singh Baghel2
Assistant Professor, Department of Roga Nidan and Vikrit Vijnana, Dhanwantari Ayurvedic Medical College,
Mathura, Uttar Pradesh, 1Assistant Professor, 2Professor and Head, Department of Roga Nidan and Vikriti Vijnana,
Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar, Gujarat, India

Abstract
Irritable bowel syndrome (IBS) is one of the most common conditions encountered in
clinical practice but one of the least well understood. Symptoms of this disorder are chronic,
sometimes severe and often respond poorly to treatment, resulting in reduced quality of life.
There is no specific test for IBS, although diagnostic tests may be performed to rule out other
problems. In present clinical trial 51 patients of IBS were registered out of which 46 patients
completed the treatment. Bilvadileha was administered for the duration of 12 weeks. The
therapy showed statistically significant improvement in all the clinical features of IBS as well as
in the IBS severity score.
Key words: Ayurvedic management, Bilvadileha, irritable bowel syndrome

Introduction Pravahika, Grahani[7] and Pakvashayagata Vat.[8] In Ayurvedic

system of medicine, the concept of psychosomatic disorders
Irritable bowel syndrome (IBS) is a vague term for a variety of has been widely discussed.[9] According to Charaka, Sharira
diseases causing discomfort in the gastro‑intestinal tract which and Manasika Doshas are interdependent on each other.[10]
causes great morbidity in the population. IBS is also called One follows other, so the diseases, which are derived from
by many names, among them colitis, mucous colitis, spastic them, also cannot exist without one another. Hence while
colon, or spastic bowel are few. It is a functional bowel disorder understanding the “Samprapti” (pathogenesis) of IBS, one
characterized by chronic abdominal pain, discomfort, bloating has to give importance to Annavaha, Purishava, Rasavaha and
and alteration of bowel habits in the absence of any organic Manovaha Srotodushti.
cause.[1] Certain psychological conditions are also more common In the management of IBS many formulations have been
in those with IBS. Diarrhea or constipation may predominate, mentioned in modern medicine. Modern therapeutic
or they may alternate (classified as IBS‑D, IBS‑C or IBS‑A, molecules may provide instant relief in these cases, but are
respectively). IBS may begin after an infection (post‑infectious, tend to develop a number of adverse drug reactions and no
IBS‑PI), a stressful life event, or onset of maturity without permanent cure is visible. Knowing this, the current suffering
any other medical indicators.[2] IBS affects 15‑20% of Indian population is looking toward new remedies from other systems
population.[3] It occurs more often in women than in men of medicines, which can provide relief without manifesting
and it begins before the age of 35 in about 50% of people.[4]
any inconveniency. Bilvadileha,[11] a promising herbal drug
Psychological factors like stress, anxiety etc., plays an important
compound that is being successfully prescribed by Ayurvedic
role in the manifestation of IBS.[5]
physicians without any side effect since centuries is evaluated
IBS is relatively a recent concept and as such is a new entry for its clinical efficacy in the condition of IBS in the present
into the realm of clinical medicine itself. As there is no single study.
disorder in Ayurveda which can be exactly co‑relate with
IBS because Ayurveda is based entirely on different basic Aims and objective
principles. Some conditions in particular, quite practically The objective is to evaluate the efficacy of Bilvadileha in IBS.
similar with IBS in their clinical picture. These are Atisara,[6]
Materials and Methods
Address for correspondence: Dr. Ramanand Tiwari,
Patients attending OPD of Department of Kayachikitsa and Rog
Sampuranand Sanskrit University Anusandhan Campus,
Nidana and Vikruti Vijnana, fulfilling the criteria for inclusion
Varanasi - 221002, Uttar Pradesh, India.
were selected irrespective of sex, race, caste and religion,
E‑mail: [email protected]
between the age group of 18‑65 years.

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Tiwari, et al.: Management of irritable bowel syndrome by Bilvadileha

Bilvadileha 6. Patients on prolonged (>6 weeks) medication with

Bilvadileha was prepared by Arya Vaidya Sala, Kottakkal ‑ 676 503, corticosteroids, anti‑depressants, anti‑cholinergics, etc.,
Kerala, India. The ingredients and the parts used are given in or any other drugs that may have an influence on the
Table 1. outcome of the study.
7. Patients suffering from major systemic illness necessitating
Pattern of study long term drug treatment Rheumatoid arthritis,
The study was an open label, single group and non‑controlled tuberculosis, psycho‑neuro‑endocrinal disorders, etc.
clinical trial. 8. Patients who have a past history of atrial fibrillation, acute
coronary syndrome, myocardial infarction, stroke or severe
Timelines arrhythmia in the last 6 months.
1. Washout/preparatory period (if required): 4 weeks
9. Symptomatic patient with clinical evidence of heart
2. Treatment period: 12 weeks
failure.
CTRI registration 10. Patients with concurrent serious hepatic disorder (defined
This clinical trial has been registered under as aspartate amino transferase (AST) and/or alanine
CTRI (Ref‑CTRI/2012/01/002348). amino transferase (ALT), total bilirubin, alkaline
phosphatase (ALP) >2 times upper normal limit) or renal
Ethical clearance disorders (defined as serum creatinine >1.2 mg/dL), severe
The study was approved by Institutional Ethics Committee (Ref pulmonary dysfunction (uncontrolled bronchial asthma
PGT/7‑A/Ethics/210‑11/1858). and/or chronic obstructive pulmonary disease), or any
other condition that may jeopardize the study.
Eligibility criteria 11. Alcoholics and/or drug abusers.
1. Patients of either sex with age between 18 and 65 years 12. History of hypersensitivity to the trial drug or any of its
2. Known case of IBS as per Rome III criteria:[12] ingredients.
(Symptoms of recurrent abdominal pain or discomfort and 13. Pregnant/lactating woman.
a marked change in bowel habit for at least 6 months, with 14. Patients who have completed participation in any other
symptoms experienced on at least 3 days/month in the last clinical trial during the past 6 months.
3 months associated with two or more of the following: 15. Any other condition which the principal investigator
• Pain is relieved by defecation thinks may jeopardize the study.
• Onset associated with change of frequency of stools
• Onset associated with a change in form (appearance) Investigation
of stools. Routine investigations were done, before (to rule out any other
3. Willing and able to participate in the study. pathology) and after treatment (to assess any untoward effect of
trial drug during the regimen).
Exclusion criteria
1. Patients with bleeding per rectum. Hematology
2. Mixed infection with parasites such as round worms, hook Hemoglobin, total leucocyte count, differential leucocyte count
worms etc. (neutrophil, eosinophil, basophil, lymphocytes, monocytes),
3. Patients with evidence of malignancy. erythrocyte sedimentation rate.
4. Patients with diabetes mellitus (B.S. [F] >126 mg%
and/or B.S. [2 h. PP] >200 mg% or hemoglobin A1c Bio‑chemistry
(HbA1c > 6.5%). Blood sugar (fasting, PP), HbA1c, blood urea, serum uric
5. Patient with poorly controlled hypertension acid, mg/dl, serum creatinine, serum glutamic oxaloacetic
(>160/100 mm Hg). transaminase (AST), serum glutamic‑pyruvic transaminase.
(ALT), total protein, serum albumin, serum globulin, A/G ratio,
serum bilirubin, conjugated bilirubin, unconjugated bilirubin,
Table 1: Each 10 g of Bilvadileha contains serum ALP.
Drug Botanical name Part used Quantity (g)
Stool examination (Microscopic)
Bilva moola Aegle marmelos Root 16 Parasites (ova/cyst), mucous, vegetative cells, occult blood.
Jeerna guda Old Jaggery ‑ 8
Ghana Cyperus rotundus Rhizome 0.125 This disease being a functional disorder, rest of the biochemical
and stool examination were conducted to rule out the exclusion
Dhanyaka Coriander sativum Fruit 0.125
criteria and after treatment the safety profile of the drug.
Jeeraka Cuminum cyminum Fruit 0.125
Truti Elettaria Seed 0.125 Interventions
cardamomum Bilvadileha has been administered to the patients at the dose of
Twak Cinnamomum Stem bark 0.125 10 g twice a day orally after food with luke warm water for the
zeylanicum duration of 12 weeks.
Naga Kesara Mesua ferrea Stamen 0.125
Shunthi Zingiber officinale Rhizome 0.125 Methods of assessment
The assessment of IBS was done at the interval of 14 days on
Maricha Piper nigrum Fruit 0.125
the basis of relief in chief complaints of IBS, disease specific
Pippali Piper longum Fruit 0.125
Ayurvedic parameters and IBS severity score.[13]

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Tiwari, et al.: Management of irritable bowel syndrome by Bilvadileha

Response at 12 weeks Out of 46 patients, after the completion of treatment with

•  ositive response to treatment‑decrease in IBS severity
P Bilvadileha, positive response to treatment was found in 37
score by >50%. (80.43%) patients, 7 (15.21%) patients showed Partial response
•  artial response to treatment‑decrease in IBS severity score
P
by 30‑50%.
Table 2: Total number of subjects registered for therapy
•  o response to treatment‑decrease in IBS severity score by
N
<30%. Status No. of patients
Registered 51
Observations and Results Completed treatment 46
Drop out 5
A total of 51 patients were registered. Out of which 5 were drop
out (Out of 5 patients drop out, 4 got transferred at another
station. Cause of drop out for one patient was unknown and Table 3: Chief complaint’s wise distribution of
46 completed the treatment [Table 2]. All the patients were 51 patients
complaining about chronic and recurrent abdominal pain Chief complaints No. of Percentage
(100%). Abdominal bloating was found in 96.08%; IBS‑C in patients
1.96%; IBS‑D in 98.04%; Passage of mucus in 94.12%; Urgency Chronic or recurrent abdominal 51 100
of bowel movements in 88.24% patients [Table 3]. discomfort or pain
In the present study, Udara Shula (Pain in abdomen), Anaha Abdominal bloating 49 96.08
(Distention of the abdomen) and Udara Atopa (Tympanitis) Constipation (IBS‑C) 1 1.96
was found in 100% patients whereas Pravahana (Tenesmus) in Diarrhoea (IBS‑D) 50 98.04
96.08% patients, Mala Tyaga Asantushti (dissatisfaction after Urgency of bowel movements 45 88.24
defecation) in 98.04% patients, Mala Durgandha (Foul odor of Feeling of incomplete evacuation 51 100
stool) in 74.51% patients, Bhojanopranta Mala Tyaga (Defecation Passage of mucus 48 94.12
after taking meals) in 80.39% patients and Guda Shula (Pain in IBS: Irritable bowel syndrome
the perianal region) was found in 41.18% patients [Table 4].
After completion of therapy, chronic and recurrent abdominal Table 4: Disease specific symptoms wise distribution
pain improved by 67.09%, Abdominal bloating by 100%; IBS‑D
of 51 patients
by 86.96%, passage of mucus by 100%; Urgency of bowel
movements by 97.50%; Feeling of incomplete evacuation by Disease specific symptoms No. of Percentage
89.13% [Table 5]. All these improvements were statistically patients
highly significant (P < 0.001). Bivadi leha has shown 95.65% Pravahana (tenesmus) 49 96.08
improvement in Pravahana. Udara Shula was improved by Udara Shula (pain in abdomen) 51 100
67.39%; Anaha  (Distention of the abdomen) by 93.48%; Mala Anaha (distention of abdomen) 51 100
tyaga Santushti (Satisfaction after defecation) by 89.13%; Mala Tyaga Asantushti 50 98.04
Kapha Nihssarana (Mucus in stool) by 100%; Udara Atopa (dissatisfaction after defecation)
by 97.83%; Mala Durgandha (Foul odour of stool) by 100%; Kapha Nihssarana (mucus in stool) 48 94.12
Bhojanopranta Mala Tyaga by 100%; Guda Shula by 67.39% Mala Durgandha (foul odour of 38 74.51
[Table 6]. All these improvements were also statistically highly stool)
significant (P < 0.001). Effect of therapy on IBS severity Udara Atopa (tympanitis) 51 100
score showed a relief of 64.59% that was statistically highly
Bhojanopranta Mala Tyaga 41 80.39
significant (P < 0.001) [Table 7]. In stool, no any significant
(defecation after taking meals)
pathological changes were seen in before and after treatment
Gud Shula (pain in perianal region) 21 41.18
stool examination.

Table 5: Effect of therapy on chief complaints

Chief complaints Mean score Percentage SD SE t P
Chronic or recurrent 0.84 67.39 0.36 0.05 15.83 <0.001
abdominal discomfort or pain
Abdominal bloating 0.89 100 0.31 0.04 19.20 <0.001
Constipation (IBS‑C) 0 - - - - -
Diarrhea (IBS‑D) 0.87 86.96 0.34 0.05 17.32 <0.001
Urgency of bowel movements 0.84 97.50 0.36 0.05 15.83 <0.001
Feeling of incomplete 0.89 89.13 0.31 0.04 19.20 <0.001
evacuation
Passage of mucus 0.95 100 0.20 0.03 31.46 <0.001
IBS: Irritable bowel syndrome, SD: Standard deviation, SE: Standard error

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Tiwari, et al.: Management of irritable bowel syndrome by Bilvadileha

to treatment and 2 (4.34%) patients reported no response to the Vitiation of Agni (Mandagni) is the main reason for IBS.
treatment [Table 8]. This ultimately results in Ama formation and may lead to
diarrhea or constipation. Bilva, due to its Kashaya, Tikta
Discussion Rasa, Katu Vipaka and Laghu Guna acts as Agni Deepana
and also Amapachaka. Kashaya Rasa and Ushna Virya help
in reducing the colonic motility. Sangrahi property of Bilva
All the cardinal symptoms and associated symptoms along with
is very useful to treat the increased frequency of defecation
IBS severity score improved in a statistically highly significant
and the consistency of stool. In Bilvadileha in addition to
manner (P < 0.001). Bilva roots are the main ingredient of the
Bilva, Prakshepa Dravyas like Dhanyak, Jirak, Ela, Keshar,
formulation Bilvadileha. The roots are sweet, astringent, bitter
Twak, Trikatu, Musta, have properties like: Deepana, Pachak,
and febrifuge; useful in diarrhea, dysentery, dyspepsia, gastralgia,
Kaphahara, Vedanasthapak, Rasayana.
palpitation, seminal weakness, uropathy, vomiting, intermittent
fever, swellings and gastric irritability in infants.[14] Thus, due to different properties of its ingredients, Bilvadileha
has properties like: Tridoshahara, Deepana, Pachana,
Amanashaka, Grahi, Vibandhahara and Vatanulomana which
Table 6: Effect of therapy on disease specific checks the Samprapti (pathogenesis) and pacify the symptoms
symptoms of IBS. Pharmacological activities such as antidiarrheal,[15]
Disease specific Mean Percentage SD SE t P antidysentry, antibacterial, antiprotozoal, antispasmodic,
symptoms score antidepressant, antifungal, antigiardiasis, anthelmintic,
Pravahana 0.95 95.65 0.20 0.03 31.46 <0.001 antispasmodic, anti‑inflammatory,[16] carminatives etc., check
(tenesmus) the IBS‑PI. Having Rasayana effect, relieve the psychological
Udara Shula 0.84 67.39 0.36 0.05 15.83 <0.001 factors such as anxiety fear etc., it may enhance the Bala of
(pain in Deha and Indriya.
abdomen)
Anaha (distention 0.93 93.48 0.25 0.03 25.39 <0.001 Conclusion
of abdomen)
Mala Tyaga 0.87 89.13 0.34 0.05 17.32 <0.001 On the basis of this study, it can be concluded that the trial
Santushti drug Bilvadileha is found to be effective in reliving symptoms of
(satisfaction after IBS. There was no adverse drug reaction seen during the period
defecation) of trial. Further studies can be should be carried out with
Kapha Nihsarana 0.95 100 0.20 0.03 31.46 <0.001 larger sample size in different places with a standard control
(mucus in stool) drug in order to obtain more data the effect of this novel drug
Mala Durgandha 0.73 100 0.44 0.06 11.29 <0.001 compound in management IBS.
(foul odor of
stool) References
Udara Atopa 0.97 97.83 0.14 0.02 45 <0.001
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