E-ISSN:2456-3110

Review Article

Shodhana Basti

Journal of Ayurveda and Integrated Medical Sciences

2024 Volume 9 Number 12 DECEMBER
Publisherwww.maharshicharaka.in

Study Protocol of an Open Label Randomized Comparative Clinical Trial to evaluate the efficacy of Shodhana Basti over Isabgol Husk in the management of Mala Avruta Pakvasyagata Vata (Chronic Functional Constipation)

Sharma B1*, Mehta A2
DOI:10.21760/jaims.9.12.16

1* Balyogeshwar Sharma, Phd Scholar, Dept of Panchakarma, Shri Krishna Ayush University, Kurukshetra, Haryana, India.

2 Ashish Mehta, Professor and HOD, Dept of Panchakarma, Shri Krishna Ayush University, Kurukshetra, Haryana, India.

Background: Constipation is used to describe symptoms that relate to difficulties in defecation. Contemporary laxatives, which are generally used in Constipation, become habitual after some duration and gives only symptomatic relief. So, it is a need of hour to search effective, safe & alternative formulations in Ayurveda, which can completely break the pathogenesis of Mala Avruta Vata. The formulation used in this study, i.e., Shodhana Basti is indicated for the treatment of Mala Avruta Pakwashyagata Vata.

Objective: The Primary aim is to assess the effect of Shodhana Basti in the management of Mala Avruta Pakvashayagata Vata. The Secondary aim is to compare the efficacy of the Shodhana Basti and Isabgol Husk in Mala Avruta Pakvashayagata Vata.

Methods: This ongoing study is an open-label randomized controlled interventional trial, with a sample size of 98 both in the trial and standard control group (including dropouts, 10%). Participants in the trial group will receive Shodhana Basti in the Kaala Basti pattern for a period of fifteen days. The participants in the control group will receive 5gm of Isabgol husk (Plantago ovata) in 200 ml of lukewarm water twice a day for 15days.

Outcome Measures: The primary outcome will include the mean change in the symptoms of Mala Avruta Vata assessed by “Bristol stool form scale” and Pureeshavruta Vata assessment scale. The secondary outcomes will include the effectiveness of Shodhana Basti in the management of Mala Avruta Vata than Isabgol Husk.

Ethics: Ethics approval was taken from the Institutional Ethics Committee following which recruitment will be commenced in January 2025.

Clinical Trial Registration: CTRI/2024/10/075705 dated 23.10.2024

Keywords: Shodhana Basti, Constipation, Isabgol Husk, Malabhaddhata, Vibandha

Corresponding Author How to Cite this Article To Browse
Balyogeshwar Sharma, Phd Scholar, Dept of Panchakarma, Shri Krishna Ayush University, Kurukshetra, Haryana, India.
Email: 		Sharma B, Mehta A, Study Protocol of an Open Label Randomized Comparative Clinical Trial to evaluate the efficacy of Shodhana Basti over Isabgol Husk in the management of Mala Avruta Pakvasyagata Vata (Chronic Functional Constipation). J Ayu Int Med Sci. 2024;9(12):132-139.
Available From
https://jaims.in/jaims/article/view/3882

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2024-11-12 2024-11-22 2024-12-02 2024-12-12 2024-12-24
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
None Nil Yes 12.76

© 2024by Sharma B, Mehta Aand Published by Maharshi Charaka Ayurveda Organization. This is an Open Access article licensed under a Creative Commons Attribution 4.0 International License https://creativecommons.org/licenses/by/4.0/ unported [CC BY 4.0].

J Ayu Int Med Sci 2024;9(12)132
Download PDFBack To ArticleIntroductionReview of LiteratureAim of studyObjectives of studyMethodologyReferences
Balyogeshwar S et al. Study Protocol to evaluate the efficacy of Shodhana Basti

Introduction

Constipation is used to describe symptoms that relate to difficulties in defecation. These include infrequent bowel movements, hard or lumpy stools, excessive straining, sensation of incomplete evacuation or blockage and, in some instances, the use of manual manoeuvres to facilitate evacuation. Symptoms may be acute, where they typically last less than a week and are commonly precipitated by a change in diet and/or lifestyle (e.g. reduced fibre intake, decreased physical activity, stress, toileting in unfamiliar surroundings). In contrast, chronic constipation is generally defined by symptoms that persist for at least 3 months.[1]

Constipation is a common gastrointestinal complaint in apparently healthy population as well as in patients with various predisposing disorders with approximately 12 to 19% global prevalence.[2] The high prevalence rate, economic burden, and adverse implications on the quality of life and the health state make constipation a major public health issue.[3,4]

Functional constipation is the most common form of constipation. The “Rome III criteria” is a widely accepted format for diagnosis of Functional Constipation.[5,6] Treatment of constipation is most often empirical. Simple, helpful measures include patient education, dietary fibre supplementation, adequate fluid intake, and regular physical activity.[7] Patients are evaluated and treated for stress and other psychosocial factors and for problems of chronic abdominal pain.[8]

Patients of constipation not benefited by the lifestyle and dietary modifications may benefit from the judicious use of suitable laxative. Various drugs such as bulk-forming agents (polycarbophil and methylcellulose), stimulants (docusate, bile acids, phenolphthalein, bisacodyl, sodium picosulfate, and ricin oleic acid), stool softeners (docusate and docusate calcium), and osmotic agents (magnesium or phosphate salts, lactulose, sorbitol, glycerine suppositories, and polyethylene glycol) are used depending upon the chronicity and severity of the condition.[6,7] Pelvic floor retraining may be helpful in the management of patients with outlet delay. Selective patients with the intractable constipation may benefit from surgery.[7] However, surgery may have serious complications and hence, is least advised.[9]

Though the conventional treatment is well established and safe, it does not provide satisfying improvement for many patients prompting their interest in other therapeutic strategies.[10] Stimulant, osmotic and saline laxatives of chemical origin are known to cause abdominal cramping, hypokalaemia, flatulence, abdominal distension, and alteration in electrolyte transportation which limit the long-term use of these drugs.[7]

Contemporary laxatives, which are generally used in Constipation, become habitual after some duration and gives only symptomatic relief. Moreover, these medicines never alter pathogenesis of disease. So, it is a need of hour to search effective, safe & alternative formulations in Ayurveda, which can completely break the pathogenesis of Mala Avruta Vata. The formulation used in this study, i.e., Shodhana Basti is indicated for the treatment of Mala Avruta Pakwashyagata Vata.[11] With this idea present study is planned to evaluate the effect of Shodhana Basti in Mala Avruta Pakwasyagata Vata.

Mala Avruta Vata is considered to be one of the health ailments which have become quite common these days. These chronic patients visited to many physicians and experts for their chronic symptoms and usually had prescribed laxatives, stool softener or patient itself takes medicine over the counter of the chemist shop.

But mild laxative, antacids and all other drugs of acid peptic disorder allow temporary relieve to symptoms but the patients may get habitual to the medicines and then patient won’t respond to the medicine and the physiological homeostasis of large intestine gets disturbed.

Review of Literature

Historical Review

Acharya’s have mentioned Pakwashaya as the Vishesha Sthana for the Vata Dosha.[12] Acharya Charaka while describing different Srotomoola mentioned Purishavaha Srotas as principal organs as Pakwashaya and Guda.[13] Large intestine begins from caecum. Pakwashaya is interpreted as large intestine is justified over here. Arunadatta explained that the organ where Purisha is formed is called Pakwashaya and it supports Purisha. While describing 'Kala' Acharya Sushruta states that this is fifth 'Kala' which helps to divide Mala or excretory products and it is located in Pakwashaya.[14]


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Acharya Susrutha in Nidana Sthana spells out that expulsion of various kinds of defecation, urination, expulsion of semen, expulsion of baby, menstruation etc. are dependent on the proper functioning of Large intestine due to its inseparable relationship with Apana Vayu[15]

In the context of Ashaya’s, Acharya Susrutha in Shareerasthana, quoted that Pakwashaya lies below the Pittashaya[16] and while explaining the location of Doshas, he also quoted that the Pakwashaya exists above the Guda, Shroni and below the Nabhi.[17]Pakwashayagata Vata is a condition of aggravated Vata in Pakwashaya i.e., the large intestine. According to Acharya Susrutha, Vata aggravated in Pakwashaya produces gurgling noise in the abdomen, pain around the umbilicus, difficulty in elimination of urine and faeces, flatulence and pain in the back.[11] According to Acharya Charaka there occurs gurgling sound in the intestine, colic, meteorism, difficulty in micturition and defecation, constipation and pain in the back.[18] According to Acharya Vagbhata, Vata aggravated in Pakwashaya gives rise to colic, flatulence, gurgling sound in the intestine, obstruction to movement of faeces, urinary calculi, enlargement of scrotum (hernia), haemorrhoids, catching pain in the lower part of the back, back and waist and other diseases concerned with the lower part of the body.[19] According to Acharya Yogaratnakara, if aggravated Vata is located inside Pakwashaya, Antrakoojana (intestinal sounds), Shoola (colic), Atopa etc. diseases are produced along with difficulty in passing of urine and faeces, Anaha and pain in lumbar region.[20] According to Madhava Nidana, there is intestinal gurgling and pain, difficulty for micturition and defecation, distension of abdomen and pain in sacral region.[21]

Chronic constipation can be correlated with Pureesha Avrita Vata[22] which is defined as the absolute constipation along with Parikartika (Fissure in Ano), Shroni Vankshana Prstha Ruk (pain in hips, groin and back) and uncomfortable sensation in chest region etc. As per Ayurveda, Vata Dosha and Pureesha Mala are the main factor involved in this condition. Therefore, the prime treatment principle recommended by Ancient Acharyas is Snigdha Udavartahara Kriya.

Ayurvedic Review (Disease)

Acharya Dalhana states that there are two categories of Pakwashaya:

Pittashaya and Vaatashaya. Pittashaya Gata Vata is the appropriate time to offer Snehavirechana with Eranda Taila or Tilwaka Ghrita. Vata received Avarna with Pitta, Kapha, and Mala in Vaatashaya.[23] According to Charaka, the symptoms of Pureesha Avruta Vata include excessive constipation, cutting pain in the anorectum, fast digestion of Snigdha substances, Anaha after meals, difficulty and delay in passing hard stool due to pressure from food, pain in the hips, groins, and back, and Vayu moving in the upward direction, which can harm the heart.[24]

Charaka states that the symptoms of Pittaavruta Apana Vata include feeling of heat in the anus and penis, Haridra (deep yellow) colour of the urine and faeces, and heavy menstrual discharge. Kaphaavruta Apana Vata is characterized by poorly formed stool, heavy in nature, ama and kapha associations, and the emergence of Kaphaja Meha.[25]

Modern Review (Disease)

Constipation is a common gastrointestinal condition characterised by unsatisfactory defaecation as a result of infrequent stools, difficult stool passage, or both.[26] Mentioned as a clinical entity by the Egyptians in the 16th century BC,[27] constipation continues to negatively impact quality of life and generate major healthcare-associated costs. The term functional constipation (FC) has been proposed and defined by the Rome Foundation to help standardise the diagnosis of chronic constipation in the absence of physiological abnormality.[28,29] As in most other disorders of brain-gut interaction, functional constipation is more prevalent in females. In addition, the prevalence increases slightly with age and is modestly increased in those with a lower socioeconomic status. Functional constipation is of primary origin and is in principle a symptom-based diagnosis. Currently, from a pathophysiological point of view, different subtypes are-

Primary or functional: An entity in which the cause of constipation cannot be identified from the clinical history and physical examination.[30] Following functional tests, primary constipation may be further classified as: Normal transit constipation (NTC); Slow transit constipation (STC), colonic inertia; outlet obstruction or pelvic floor dysfunction; and combined causes (slow transit constipation and pelvic floor dysfunction).


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Nullens et al. evaluated 1411 patients with chronic constipation at a medical centre and found that 68% had constipation with normal transit, 27.6% with outlet obstruction and 4.3% with slow transit or colonic inertia.[31]

Secondary or organic: Constipation for which the clinical assessment and workup identifies intestinal or extra-intestinal abnormalities, metabolic or hormonal factors and medications as responsible for the defecatory disturbances.[32]

Intestinal: Tumour’s, diverticulitis, inflammatory strictures, ischemia, volvulus, endometriosis, postoperative strictures, anal fissure, thrombosed haemorrhoids, mucosal prolapse, ulcerative proctitis.

Medication-induced: Antidepressants, antiepileptics, anti-histamines, antispasmodics, anticholinergics, calcium channel blockers, calcium and iron supplements & non-hormonal anti-inflammatories.

Metabolic diseases: Hypothyroidism, hypoparathyroidism, hypercalcemia, hypokalaemia, hypomagnesemia, diabetes mellitus, uremia, and heavy metal poisoning.

Neuropathies: Medullar lesions or neoplasia, cerebrovascular disease, multiple sclerosis, autonomic neuropathy and Parkinson’s disease.

Myopathies: Amyloidosis and scleroderma.

Other conditions: Chagas disease, cognitive impairment, immobility.

Drug Review

Acharya Dalhan states that Shodhana Basti is treatment for Mala, Pitta & Kapha Avruta Vata having Kashaya, Kalka, and Sneha accordingly. So, treatment of Mala Avruta Vata is Shodhan Basti having Vidari Kalka, Sneha and Kshara. Basti should be Vyakta Ushna at time of administration.[23] Acharya Charaka mentioned Pakwashaya Shodhana Basti having Kashaya Dravya of Madanaphala, Jimutaka, Ikshavaku, Dhamargava and Kutaja.[33] Charaka states that Udavarta Chikitsa should be followed for treating Pakwashayagata Vata. [34]

Aim of study

To evaluate the efficacy of Shodhana Basti over Isabgol Husk in the management of Mala Avruta Pakvasyagata Vata

Objectives of study

A) Primary

To assess the effect of Shodhana Basti in the management of Mala Avruta Pakvashayagata Vata.

B) Secondary

To compare the efficacy of the Shodhana Basti and Isabgol Husk in Mala Avruta Pakvashayagata Vata

Methodology

Type of Study - Clinical Study

Research Design: An Open Label Randomized Comparative clinical trial

Source of Data - Patients with symptoms of Functional constipation fulfilling inclusion criteria.

  • Participants - OPD & IPD of BKNGAC & Hospital, Narnaul
  • Clinical Source - CRF
  • Literary Source - Ayurvedic Texts, Research articles, thesis, papers
  • Type Of Study - Interventional

Diagnostic criteria - Rome III diagnostic criteria for functional constipation

Inclusion Criteria

1. Patients meeting the “Rome III diagnostic criteria for functional constipation” [patients presenting with two or more of the following for the last three months with symptom onset at least six months prior to diagnosis: (a)Straining during at least 25% of defecations, (b) Lumpy or hard stools at least 25% of defecations, (c) Sensation of incomplete evacuation at least 25% of defecations, (d) Sensation of anorectal obstruction/blockage at least 25% of defecations, (e) Manual manoeuvres to facilitate at least 25% of defecations, e.g., digital evacuation, support of the pelvic floor, (f) Fewer than three defecations per week and those in whom loose stools were rarely present without the use of laxatives] were included.
2. Patients with a stool form score ranging from 1 to 3 on the “Bristol Stool Form Scale”
3. Patient with the symptom of Mala-Avruta Vata
4. Sex: Male & Female
5. Age: 20 to 60 Years.
6. Patient ready to give written consent


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Exclusion Criteria

1. Patients on chronic laxative medication (>60 days) and/or who were on medications known to cause constipation (like opioid analgesics, antidepressants, i.e., amitriptyline and imipramine, anticonvulsants, and aluminium-containing antacids) were excluded.
2. Those with functional gastrointestinal disorders other than Functional constipation (i.e., IBS, Belching disorders, etc.) were also excluded.
3. Patients with a history of abdominal or anorectal surgery in the past one year and those with renal or liver dysfunction or colonic inertia or structural abnormalities of gastro-intestinal tract or uncontrolled systemic ailments (like Human immunodeficiency virus, Diabetes mellitus, and Tuberculosis) or neurological problems (like Parkinson’s disease, multiple sclerosis, sacral nerve damage, and paraplegia or autonomic neuropathy) were excluded.
4. Pregnant (pregnancy assessed by urine pregnancy test) or lactating women were excluded.
5. Patients allergic to any of the ingredients of the study medication were excluded.
6. Patients not willing for clinical trial.
7. Patients of neoplastic condition
8. Patients in whom Basti is contraindicated
9. Patient of secondary intestinal constipation will be excluded

  • Withdrawal criteria: due to ADR, Emergency condition
  • Sample size: 98 (44 in each group + considering 10% Dropouts)

In Control Group-49, In Trial Group-49

  • Sampling technique: Probability Sampling by generating random number sequence using related software
  • Blinding techniques study: No
  • Random allocation method: SNOSE
  • Name and place where the study will be conducted: BKNGAC & Hospital, Patikara, Narnaul
  • Criteria of Assessment: The main symptoms and associated symptoms of functional constipation will be assessed using the Visual Analogue Scale (VAS scores ranging from 0 to 100 mm) grading constipation from "0" ("no problem at all") to "100" ("terrible problem") and Bristol stool form scale.

  • The patient will provide with a diary card to note down the details of his/her daily bowel evacuations and other symptoms.
  • Assessments will be conducted on baseline visit, as well as on days 7th, 15th, 30th, 45th, and 60th day following the end of treatment.
  • Assessment scale of Pureesha Avrita Vata will be used to assess the classical sign and symptoms of Mala Avruta Vata.

Table 1: Assessment scale of classical sign and symptoms of Mala Avrita Vata[35]

No Problem - 0 score, Some Problem - 1 score, Severe Problem - 2 score

SNLakshanaBTDuring TreatmentAfter Treatment
Zero Day7th Day15th Day30th Day45th Day60th Day
1.  Absolute Constipation
2.  Instantaneous digestion of the ingested fat
3.  Pain in Hips, Groin and Back
4.  Upward movement of vata in abdomen
5.  Uncomfortable sensation in chest region
Total

Grouping

1. Control Group: Patients will be advised to mix 5gm of Isabgol Husk (Plantago ovata) in 200 ml of lukewarm water, stir well, and consume immediately twice a day for 15days.
2. Trial Group: Trial group participants will get Shodhana Basti in the Kaala Basti pattern for a period of fifteen days. Trial Group Intervention Pattern:

Day 1Day 2Day 3Day 4Day 5Day 6Day 7Day 8Day 9Day10
ABNBABNBABNBABNBABNB

Day11Day12Day13Day14Day15
ABNBABABAB

Follow-Up: After that follow-up will be conducted on 30th, 45th and 60th day. They will allow to report for a scheduled visit after maximum of three days from the scheduled date. Those reporting later than this grace period will be considered as dropouts.


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Interventions

Procedure/ Drug: Shodhana Basti (Dalhana Tika on Su.Chi.4/5)

Table 2: Composition of Shodhana Basti

Basti DravyaIngredientsQuantity
Kwatha DravyaMadanaphal, Vatsaka, Trivruta, Aaragwadha, Lodhra, Danti8 Pala (320ml)
KalkaPutoyanyadi Churna2 Pala (80gm)
SnehaMurchita Tila Taila6 Pala (240ml)
Madhu-4 Pala (160ml)
PrakshepaGomutra4 Pala (160ml)
Saindhava-1 Aksha (10gm)
Total960ml
Anuvasana BastiMurchita Tila Taila120ml

Preparation of Basti Dravya and procedure of Basti will be done according to description available in text.

Time Period need for completion of study per patient - 60 days

Expected Outcomes

1. Primary outcome: Shodhana Basti will show improvement in the symptoms of Mala Avruta Vata assessed by “Bristol stool form scale” and Pureeshavruta Vata assessment scale.
2. Secondary outcome: Shodhana Basti will be more effective in the management of Mala Avruta Vata than Isabgol

Statistical Software and test to be used: as required.

Statistical analysis: at 95% confidence interval, 5% Type I error and 80% power of the study

Data analysis: A detailed Case Performa will be prepared according to protocol of study and all the parameters will be given suitable scoring depending upon their severity for assessment of efficacy of treatment. The data will be statistically analysed by and will be presented in the form of dissertation.

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