E-ISSN:2456-3110

Research Article

Study of Digestive Health Capsules

Journal of Ayurveda and Integrated Medical Sciences

2024 Volume 9 Number 4 April
Publisherwww.maharshicharaka.in

A clinical study of Digestive Health Capsules in the management of Grahani Roga with special reference to Irritable Bowel Syndrome

Jat R1*, Gavali P2, Godatwar P3, Jain H4, Kumar Patel N5, Peston Jamas J6
DOI:10.21760/jaims.9.4.3

1* Rohini Jat, Post Graduate Scholar, Department of Roga Nidana Evam Vikriti Vigyana, National Institute of Ayurveda De Novo, Jaipur, Rajasthan, India.

2 Preeti Gavali, Assistant Professor, Department of Roga Nidana evam Vikriti Vigyana, National institute of Ayurveda De Novo, Jaipur, Rajasthan, India.

3 Pawankumar Godatwar, Technical officer, SEARO WHO, New Delhi, India.

4 Harshad Jain, Ayurvedic Medical Practitioner, Bombay Hemp Company Pvt Ltd, Mumbai, Maharashtra, India.

5 Neeraj Kumar Patel, Head of Research Development, Bombay Hemp Company Pvt Ltd, Mumbai, Maharashtra, India.

6 Jahan Peston Jamas, Chief Strategy Officer, Bombay Hemp Company Pvt Ltd, Mumbai, Maharashtra, India.

Background: Clinical manifestation of Grahani Roga is similar to irritable bowel syndrome (IBS). IBS is not a life-threatening condition but it can significantly impact the quality of life. The prevalence of IBS varies from 12% to 15% in India. It is 3 times more common in women and people of working age. Due to the wide spectrum of disease, much prevalence in society and lack of effective medicines, the disease has been chosen for the trial. Digestive Health Capsules manufactured by Bombay Hemp Company is used in patients suffering from Grahani Roga (IBS). Aim: The aim of this study was to study the safety and efficacy of Digestive Health Capsules in the management of Grahani Roga (IBS). Materials and Methods: Forty clinically diagnosed patients of Grahani Roga (IBS) were selected and administered Digestive Health Capsules - 1 capsule twice a day with water after meal for 8 weeks. Study Design: It was an open labeled, single center, single arm clinical study. Results: The result was highly significant for all the subjective and objective parameters. Conclusion: Digestive Health Capsules can be used as safe and effective drug of choice in patients suffering from Grahani Roga (Irritable Bowel Syndrome).

Keywords: Grahani Roga, Digestive Health Capsules, Irritable Bowel Syndrome, Quality of Life

Corresponding Author How to Cite this Article To Browse
Rohini Jat, Post Graduate Scholar, Department of Roga Nidana Evam Vikriti Vigyana, National Institute of Ayurveda De Novo, Jaipur, Rajasthan, India.
Email: 		Jat R, Gavali P, Godatwar P, Jain H, Kumar Patel N, Peston Jamas J, A clinical study of Digestive Health Capsules in the management of Grahani Roga with special reference to Irritable Bowel Syndrome. J Ayu Int Med Sci. 2024;9(4):16-28.
Available From
https://jaims.in/jaims/article/view/3107

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2024-02-17 2024-02-27 2024-03-07 2024-03-18 2024-03-24
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
None Nil Yes 22.55

© 2024by Jat R, Gavali P, Godatwar P, Jain H, Kumar Patel N, Peston Jamas Jand 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].

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Rohini Jat et al. Digestive Health Capsules in the management of Grahani Roga

Introduction

In today’s era, the lifestyle of people has changed, which influences the physical and psychological health. This is the root cause of many non-communicable diseases, especially metabolic diseases. Due to sedentary lifestyle and busy schedule people are often dependent on the pre-cooked (ready to eat) food that results in lack of important nutrients required to maintains health. Irregular food habits and timing and sedentary life play an important role in manifestation of diseases. All these factors lead to the irregular functioning of gastrointestinal tract which are often ignored in their early phase. Once they convert into chronic stage, the disease becomes difficult to cure.

Irritable bowel syndrome (IBS) is a frequent cause of abdominal pain and altered bowel habits worldwide. As per the Rome IV criteria, the disorder is characterized by recurrent abdominal pain associated with defecation or changes in stool frequency or form.[1] The syndrome is not a significant cause of mortality, yet it is associated with substantial healthcare utilization and reduction of quality of life.[2] Health related quality of life (HRQoL) data suggest physical impairment similar to patients with diabetes and a greater degree of impairment than those with depression and gastro-esophageal reflux disease.[3] The exact pathophysiology of IBS remains unclear. Proposed mechanisms include gut motility dis-regulation, altered microbiomes, visceral hypersensitivity and altered brain-gut interaction.[4] Other factors are exposures, inflammatory triggering, genetic susceptibility and psychological states.[5]

According to Acharya Charaka, Sharira and Manasika Doshas are interdependent on each other.[6] Psychological factors like stress, anxiety etc., plays an important role in the manifestation of IBS.[7] IBS is relatively a recent concept and as such is a new entry into the realm of clinical medicine itself. As there is no single disorder in Ayurveda which can be exactly correlates with IBS because Ayurveda is based entirely on different basic principles. Some conditions in particular, quite practically similar with IBS in their clinical picture, are Atisara,[8] Pravahika, Grahani[9] and Pakvashayagata Vata.[10] In Ayurvedic system of medicine, the concept of psychosomatic disorders has been widely discussed.[11]

In the management of IBS, many formulations have been mentioned in modern medicine. Modern therapeutic molecules may provide instant relief in these cases, but are tend to develop a number of adverse drug reactions and provide no permanent cure. Historically, medical management has focused on symptomatic treatment of these individual complaints.[12] Knowing this, the current suffering population is looking toward other systems of medicines which can provide cure not only relief, without manifesting any inconveniency.

In Grahani Roga (IBS), mainly there is vitiation of Agni, usually Mandagni is seen. This ultimately results in Ama formation. In this condition, Tikta Katu dominant Rasa of the ingredients help in digestion of Ama and ultimately break the pathogenesis of the disease. Besides this, there is dominancy of Laghu, Ruksha Gunas in Digestive Health Capsules which also helps in Kaphaghna property. This formulation dominantly has two Dravyas with Ushnavirya and two Dravya with Sheeta Virya which helps to pacify the Vata Dosha while Deepana and Pachana properties of the ingredients help to digest the Ama and control the Vata Dosha. The result of this trial is being presented here.

Aims and Objectives

1. To evaluate the safety and efficacy of Digestive Health Capsules in the management of IBS.

2. To assess the change in the Quality of Life score in the study group.

Materials and Methods

In this study, with the above-mentioned aims and objectives, the clinical study progressed utilizing the clinical material is as under:

Selection of patients

A total of 40 patients of Grahani Roga between the age group of 18 and 65 having classical sign and symptoms of Grahani Roga (Amavastha), i.e., Muhu Baddha and Drava Mala Pravritti, Aruchi, Udara Shoola, Vishtambha,[13] etc., were randomly selected from survey study irrespective of their sex, religion, occupation, etc., attending the OPD of the Roga Nidana Evum Vikriti Vigyana department, National Institute of Ayurveda, Jaipur for the present study.


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Subjects were enrolled for the study considering the criteria of inclusion and consent was obtained from each patient in the study. The registered patients were given Digestive Health Capsules for internal use with water after food for 8 weeks. Study evaluation visits were made at baseline and screened subjects were asked to visit after every 15th day i.e., visit 1 (day 0), visit 2 (day 15), visit 3 (day 30), visit 4 (day 45), visit 5 (day 60). The study was conducted in compliance with Good Clinical Practice guidelines (ICH) and the declaration of Helsinki and national regulations. This was an open label, single arm, investigator-initiated drug trial in phase-2, comparing the efficacy and safety of the drug before and after intervention, and also studying the same at every follow-up of the patient.

Pattern of study: The study was an open labeled, single center, single arm clinical study.

Treatment period: 8 weeks

CTRI registration: This clinical trial has been registered under CTRI (Ref CTRI/2022/03/041004).

Ethical clearance: The study was approved by Institutional Ethics Committee (IEC/ACA/2021/02-83)

Diagnostic criteria

All the patients were diagnosed on the basis of classical signs and symptoms of Grahani Roga (Amavastha). For the purpose of perfect diagnosis and assessment, a special research proforma was designed for the study incorporating all the relevant points from both Ayurvedic and modern views. The routine hematological, biochemical, urine, and other examination were carried out to assess the general condition and exclusion of other pathogenesis of the patients.

Inclusion criteria

  • Patients between 18 and 65 years of age.
  • Ability to consent to the study and able to read and write in English or local language.
  • Subjects who are non-regular users of cannabis in any form (three times per week or more) and are willing to abstain for 1 week prior and during the study.
  • Normal liver function (defined as aspartate aminotransferase 10-40 U/L and alanine aminotransferase 7-56 U/L)
  • Normal renal function (defined as serum creatinine level < 133 umo/L and Estimated Glomerular Filtration Rate (eGFR) equal or higher than 60)
  • Accepting not to use products with the same end benefit during the entire study duration.
  • Subjects willing to stop alcohol, caffeine and nicotine consumption during the study duration.
  • Cooperating, ready to sign consent form and ready to comply with protocol procedures.

Exclusion criteria

  • Previous serious adverse event or hypersensitivity to cannabis or cannabinoids. Subjects receiving opioids and other concomitant anxiety medications.
  • Presence of significant cardiac disease (history of unstable ischemic heart disease, heart failure, severe and uncontrolled hypertension) that, in the opinion of the investigator, would put the patient at risk of a clinically significant arrhythmia or myocardial infarction.
  • Current substance use disorder evaluated by history.
  • Life-time history of dependence on cannabis or diagnosis of cannabis use disorder.
  • Pregnant women tested positive in UPT and lactating women or women planning pregnancy during the trial period. willing to ensure that they or their partner use effective contraception during the study period.
  • Current use of cannabis in any form more than 3 times per week or use of cannabinoid-based medications within 7 days of study entry and refusal to abstain for the duration of the study.
  • Positive blood test for cannabinoids at screening or positive urine screening for other potential abuse substances (e.g., alcohol, cocaine, amphetamines and methamphetamines, un prescribed opioids).
  • For whom the Investigator considers that he/ she will not be compliant with study procedures.
  • Any clinically significant systemic or cutaneous disease, which may interfere with study procedures.
  • Participation in another clinical trial within 90 days of screening visit.

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Drug and method of its preparation

Digestive Health Capsule’ was the drug selected for the trial. The formulation of drug was kept confidential as per the protocol of the company.

Table 1: Each capsule contains extract of the following herbs

SNIngredientsBotanical NamePart UsedQty/Cap.
1.VijayaCannabis sativaLeaf200 mg
2.ShunthiZingiber officinaleRhizome100 mg
3.KutajaHolarrhena antidysentericaStem bark300 mg
4.BilvaAegle marmelosFruit200 mg

The medicine was prepared in the Bombay Hemp Company Private Limited. All the subjects were advised to continue their regular diet and exercise regimen during the entire study.

Duration of clinical trial and follow up study

1. Oral drug administration for 8 weeks.

2. All patients were followed up on the interval of 15 days for 2 months.

Methods of assessment

The assessment of IBS was done at the interval of 15 days on the basis of relief in chief complaints of IBS, disease specific Ayurvedic parameters and IBS severity score[14] and IBS-36 Quality of life scale.

Withdrawal Criteria

  • A patient is considered as a dropout if he/she does not report for a follow up visit for more than 15 days after the scheduled date of visit.
  • If the participant withdraws the consent for any reason
  • If the participant is lost to follow up.
  • If the participant’s clinical condition worsens in spite of currently prescribed medications.

Assessment criteria

The assessment was done by considering changes in the subjective parameters before and after the treatment. The primary and secondary efficacy variables were recorded, some at every visit and others, before and after treatment.

  • Clinical sign and symptom of Grahani Roga were recorded before and at the end of the treatment. These included clinical signs and symptoms of Grahani Roga which were i.e., Muhu Baddha
  • and Drava Mala Pravritti, Aruchi, Udara Shoola, Vishtambha
  • Assessment of change in IBSSS Scale[15] (Irritable Bowel Syndrome Severity Scoring Scale) on every follow up of patient. A questionnaire was made consisting of 6 questions. Each question was scored accordingly to the patient’s symptoms. IBS-SSS is a composite score of abdominal pain, number of days with abdominal pain, bloating/distension, satisfaction with bowel habits and IBS-related quality of life (QoL). Each measure is rated from 0 to 100, with total scores ranging from 0 to 500.
  • QoL was evaluated with a thorough 36-item IBS-related QoL questionnaire[16] (improvement in WHO IBS 36 - Quality of life score), analyzed as a total score before (day 0) and after (day 60) completion of trial and as subscales on dysphoria, interference with activity, body image, health-related worries, food avoidance, social reactions, sexual and relationships.
  • Assessment of Safety of the product was assessed by the physician and subject on the global assessment scale (GAS).
  • All patients were contacted via phone prior to each follow up to inquire about medicine dose and any adverse events (AEs).

Patients were questioned at every visit for common drug related symptoms as per a predetermined checklist and encouraged to add any other symptom they considered as a drug-related side effect. At the end of study, no adverse event was found.

Observations

Out of 44 registered patients, 40 completed the study. Four patients dropped out as they didn’t complete the follow-up. The maximum number of patients were in the age group of 18-32 years of age (60%), male (75%), and had weight in the range 61-70 kg (52.5%).

Maximum no. of subjects was married (57.5%) and Hindu (90%). In the study, 45% of subjects were graduate and 59.4% subjects were involved in sedentary work without physical labor as seen by desk work. Majority of the subjects were from Sadharana Desha.


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Dashavidha Pariksha biostatistics revealed that maximum numbers of the patients were having Vata-Pitta Deha Prakriti (65%), 40 % were having Rasa Sara followed by 27.5 % Mamsa Sara, 60% of the subjects had Madhyama Samhanana, 77.6% had Madhyama Pramana, 80% had Madhyama Satva, 72.5% had Madhyama Satmya, 72.5% Madhyama Vyayama Shakti, 77.5% had Madhyama Abhyavaharana Shakti, and 81.5% had Avara Jarana Shakti and 72.5% subjects had Mahyama Vyayama Shakti.

Review of the personal dietary history showed that 52.5 % were vegetarian, 60.3% were facing Aruchi, 72.3 % were having regular diet pattern, 54.4% of patients were doing Pramitasana, 38.6 % & 22.8 % patients were consuming Madhura and Katu Rasa respectively and 74.3 % have taking Ushna Tikshana Guna Pradhana Aahara in their diet at any time. 47.5% of subjects were usually consuming heavy food, whereas 56.4 % subjects were sometimes taking street food.

Review of the personal history showed that maximum numbers of the patients (70.6%) were doing work for 6−8 hours and majority were involved in sedentary work or activities, 67.5% of the patients were having normal sleep and 67.5% were having unsatisfactory bowel habit, 67.5% were having anxiety/tension followed by 32.5% who were depressed. In 37.88% patients, the frequency of stool was observed 3 to 4 times in a day, and 37.5% patients were suffering from disease for more than three years.

Review of the etiological factors: Ati Katu Ahara in 82.5% patients, Ati Snigdha (61.4%), Ati Amla Ahara (32.6%), Ati Guru Ahara (54.5%), Ati Sheeta Ahara (43.6%), and Vishamashana (44.6%) were observed as Aaharaja Nidana. Whereas Diva Swapana in 46.6% patients, Vega Vidharana (54.5%), Ratri Jagarana (30.5%), and Ati Vyayam (30.6%) were observed as Viharaja Nidana, Chinta in 52.4% patients, Shoka (42.5%), Krodha (39.6%), and Bhaya (24.8%) were observed as Manasa Nidana. In 38.4% patients, Atisara was found as Nidanarthakara Roga.

Chief complaints observed in patients were Muhu Baddha and Drava Mala Pravritti (100%), Apachana and Aruchi each (72.3%), Udara Shoola (78.6%), Udara Guarava (67.8%), Atop (84.5%), Vidaha (45.8%), Vistambha (34.8%), Aalasya (36.6%), and Praseka in 16.5% patients.

Review of Rasavaha Shrotas Dusti lakshanas like Angamarda was found maximum i.e., in 85 % patients followed by 80 % Aganimandhya. Aruchi was also evident in 45 % patients.

In this present study, Annavaha Srotas Dushti Lakshanas like Atopa was found in 82.5 % of patients, Anannabhilasa in 67.5 %, Arochaka in 57.5 % and Kanthadaha in 47 %.

Amongst Purishavaha Srotas Dushti Lakshanas, Anaha, Drava and Shleshmamalapravritti were found in all the patients whereas Alpa Pravritti was found in 32.5 % of patients.

On assessing the patients on IBS severity score, maximum patients had a severity score of > 300 (57.5 %) followed by 42.4 % of patients having moderate severity score. None of the registered patient was having mild severity score.

Statistics used

  • The data has analyzed using Instat graph pad-3, free trial version, Graph Pad by Dotmatics.
  • For nonparametric data, Wilcoxon matched pairs signed ranks test is used, while for parametric data, paired t-test is used.

Result

Effect of therapy on Subjective Parameters

Table 2: Showing the effect of trial medicine (Digestive Health Capsule) on IBS Severity Scoring Scale in study group

SymptomsMeanDiff.% Relief± SDSEMWPSig.
B.TA.T
Abdominal pain0.8750.0750.8910.4050.064528.0<0.0001ES
Severity of abdominal pain3.151.0752.075661.2480.197595.0<0.0001ES
Number of days that get the pain in every 10 days.4.6750.24.475962.8640.453630.0<0.0001ES
Abdominal distension1.000.0750.925930.2670.042703.0<0.0001ES
Severity of abdominal distension3.51.052.45701.1080.175741.0<0.0001ES
Satisfaction with bowel habit3.0751.2251.850600.8640.137703.0<0.0001ES
IBS affecting life in general3.051.151.9620.90.142703.0<0.0001ES

The data above shows that the medicine provided extremely significant result (P<0.0001) in all the symptoms with maximum relief (96%) in number


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of days that get the pain in every 10 days followed by 93% improvement in abdominal distension, 91% in abdominal pain, 70% improvement in severity of abdominal distension, 66% in severity of abdominal pain, 62% in IBS affecting life in general, 60% in satisfaction with bowel habit.


Graph 1: IBS-SSS variable wise symptoms relief percentage


Graph 2: IBS QOL-36 variable wise symptoms relief percentage

The data Below shows that the medicine provided extremely significant in all the symptoms with maximum relief (96%) in troubled by abdominal pain followed by 93% improvement in missing daily activities, 91% in afraid that bowel symptoms were getting worse and troubled by

bowel movements that were hard/difficult to pass, 90% improvement in discouraged due to bowel problem and interfere to concentrate, 89% in need to go suddenly when had a bowel movement and symptoms interfere with daily activities, 88% improvement in felt isolated from family and embarrassed because of bowel symptoms, 87% in felt worried about never feeling better, 86% in other thought symptoms were not real and felt angry, 84% improvement in stop participating in sports activities, 82% in interfere with relationship with children or partner, 78% improvement in symptoms like afraid to eat, 72% improvement in avoid food.

Table 3: Showing the effect of trial medicine on IBS Quality of life - 36 in study group

SymptomsMeanDiff.% Relief± SDSEMWPSig.
Afraid to eat4.6751.0503.625781.2540.198820.0<0.0001ES
Felt angry4.90.74.2861.5220.241780.0<0.0001ES
Need to go suddenly when had a bowel movement4.8750.554.325891.1410.18820.0<0.0001ES
Interfere with relationship with children or partner1.8250.251.575821.8520.293190.0<0.0001ES
Avoid food4.351.2253.125721.4880.235703.0<0.0001ES
Bowel symptoms interfere with daily activities4.2750.4753.8891.4180.224780.0<0.0001ES
Other thought symptoms were not real3.1250.4252.7861.6520.261528.0<0.0001ES
Discouraged due to bowel problem4.4500.4254.05901.3390.212780.0<0.0001ES
Stop participating in sports activities4.3250.6753.650841.3690.216780.0<0.0001ES
Felt worried about never felling better4.6250.5754.05871.3580.215780.0<0.0001ES
Miss daily activities4.250.33.950931.1540.182780.0<0.0001ES
Bowel symptoms interfere to concentrate4.30.4253.875901.1140.176820.0<0.0001ES
Felt isolated from family3.40.43.0881.320.209703.0<0.0001ES
Embarrassed because of bowel symptoms4.2250.53.725881.2190.193780.0<0.0001ES
Troubled by abdominal pain4.1250.153.975961.8470.292630.0<0.0001ES
Afraid that bowel symptoms were getting worse4.80.4254.375911.300.163820.0<0.0001ES
Troubled by bowel movements that were hard/difficult to pass4.5250.44.125911.0670.169820.0<0.0001ES


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Table 4: Showing the effect of trial medicine on IBS Quality of life - 36 in study group

SymptomsMeanDiff.% Relief± SDSEMWPSig.
Check diet from the previous day trying to find foods that might cause bowel symptoms4.6250.953.675790.9970.158820.0<0.0001ES
Avoid travelling4.2750.6253.65851.1220.177780.0<0.0001ES
Shorten the length of work time of each day4.000.2753.725930.8470.134820.0<0.0001ES
Bowel symptoms disturbed sound sleep3.250.1753.075941.0470.166741.0<0.0001ES
Troubled by loose bowel movements4.50.354.15921.0990.174820.0<0.0001ES
Symptoms interfere with having sexual relations1.8250.4251.4821.5660.248190.0<0.0001ES
Bloating troubled4.70.2754.425940.7810.123820.0<0.0001ES
Symptoms interfere with enjoyment of sport or other activities4.0750.2253.85940.8340.132820.0<0.0001ES
Passing large amount of gas5.40.255.15950.6620.105820.0<0.0001ES
Concerned that symptoms may be due to cancer2.5250.002.5251001.4140.224561.0<0.0001ES
Delay or cancel going out socially4.3250.254.075941.0950.173820.0<0.0001ES
Tired in the morning because of bowel symptoms4.6250.3754.25921.1490.182820.0<0.0001ES
Bowel symptoms interfere with desire to have sexual relations1.8750.1751.7901.80.285210.0<0.0001ES

The data above shows that the medicine provided extremely significant in all the symptoms with maximum relief (100%) in concerned that symptoms may be due to cancer followed by 95% improvement in passing large amount of gas, 94% in disturbed sound sleep, troubled by bloating, symptoms interfere with enjoyment of sport or other activities, delay or cancel going out socially, 93% improvement in shorten the length of work time, 92% in troubled by loose bowel movements and tired in the morning because of bowel symptoms, 90% improvement in symptoms interfere with desire to have sexual relations, 85% in avoid travelling, 82% improvement in symptoms interfere with having sexual relations and 79%

improvement in check diet from the previous day trying to find foods that might cause bowel symptoms.


Graph 3: IBS QOL-36 variable wise symptoms relief percentage

Table 5: Showing the effect of trial medicine on IBS Quality of life - 36 in study group

SymptomsMeanDiff.% Relief± SDSEMWPSig.
B.TA.T
Need to go to the bathroom even though bowels are empty troubled4.2750.2254.05950.9860.156820.0<0.0001ES
Immediately need to find where washrooms are at new place4.0750.353.75910.8770.139820.0<0.0001ES
Avoid planning activities ahead of time because unsure of how bowel symptoms would be4.4250.3254.1931.0080.159820.0<0.0001ES
Accidental soiling of your underwear troubled2.750.152.6951.3360.211703.0<0.0001ES
Delay work / school /usual daily activities because of bowel symptoms4.250.2753.975931.050.166820.0<0.0001ES

The data above shows that the medicine provided extremely significant in all the symptoms with maximum relief (95%) in need to go to the bathroom even though bowels are empty troubled and accidental soiling of your underwear troubled followed by 93 % improvement in avoid planning activities ahead of time because unsure of how bowel symptoms would be and in delay


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work / school /usual daily activities, 91 % improvement in immediately need to find where washrooms are at new place.


Graph 4: IBS QOL-36 variable wise symptoms relief percentage

Table 6: Showing the Effect of Digestive Health Capsules on Total Score of IBS Quality of life - 36 in Study Group

IBS-QOL 36 ScaleMean Score% Relief± SDSEMWPSig.
130.159219.4863.081820<0.0001ES

Table shows that trial medicine provided an extremely significant result (P<0.0001) with 92 % of relief on total score of IBS Quality of life -36 Scale.


Graph 5: Percentage relief on IBS QOL-36 total score

1. Effect of therapy in objective parameters (lab investigations) (Paired T – Test)

  • Hematological parameters like total RBC count were increased with the percentage of change by 4 % which is statistically extremely significant (P <0.0001) and Hb was increased with the percentage of change by 3 % which is statistically very significant (P = 0.0004). Other parameters like HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, total WBC count, Platelets with 1 %, 0 %, -2 %, 0 %, 0 %, -1 %, 4 %, 4 % respectively which did not showing significant result.
  • WBC parameters like Neutrophil were increased with the percentage of change by 6 % which is statistically very significant (P =0.0008), remaining lymphocytes, monocytes, eosinophils, basophils were decreased with the percentage of change by -7 %, -10 %, -16 %, -10 % respectively which is statistically significant.
  • LFT parameter SGOT showed significant result whereas SGPT and total serum bilirubin, direct bilirubin, indirect bilirubin, serum alkaline phosphatase, sr. albumin and sr. globulin showed statically non significant result.
  • Lipid profile parameters like sr. cholesterol and sr. HDL were increased with the percentage of change by -6 % and 6 % respectively which is statistically extremely significant (P <0.0001).
  • Other parameters like sr. triglyceride, serum VLDL both were found statistically non-significant with the percentage of change by -4 % and 4 % respectively. Sr. LDL was decreased with the percentage of change by -7 % which is statistically very significant.
  • Random blood sugar level was decreased with the percentage of change by -3 % which is statistically non-significant.
  • Urea was increased with the percentage of change by 6 % which is statistically non-significant and Sr. Creatinine was increased with the percentage of change by -1 % which is also statistically non-significant.
  • Urine PH was increased with the percentage of change by 2 % which is statistically non-significant and there is no change in specific gravity which is also statistically non-significant.

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Discussion

Probable mode of action of the drug Digestive Health Capsules

Ingredients of Digestive Health Capsules are Bhanga (Cannabis sativa) 1/4 part, Shunthi (Zingiber officinale) 1/8 part, Kutaja (Holorrhenaanti dysenterica Linn.) 3/8 part, and Bilva (A. marmelos Corr.) 1/4 part.

In this combination, Tikta Katu dominant Rasa of the ingredients help in digestion of Ama and ultimately break the pathogenesis of the disease. Besides this, there is dominancy of Laghu, Ruksha Gunas in Digestive Health Capsules which also helps in Kaphaghna property. This formulation dominantly has two Dravyas with Ushnavirya and two Dravya with Sheeta Virya which helps to pacify the Vata Dosha while Deepana and Pachana properties of the ingredients help to digest the Ama and control the Vata Dosha.

Vijaya has been attributed with different pharmacological properties i.e., Tikta Rasa, Laghu Guna, Usna Virya and Katu Vipaka. It pacifies Kapha and Vata Dosha, increases Pitta Dosha and has Dipana, Pachana, Rochana, Madakari and Vyavayi action.

Kutaja (Holorrhena antidysenterica Linn.) possess Tikta Kashaya Rasa, Katu vipaka, Sheeta Virya, Laghu, Ruksha guna, and Kapha-pittahara. It has many qualities as Deepana, Grahi, Jwarghna, Atisarghna, Arshoghna, Krimighna, Kushthaghna, Upashoshana, Raktastambhana, Dhatushoshana, and Vamaka. It shows pharmacological actions such as antidiabetic, anti-urolithic, antibacterial activity, anti-hemorrhoidal, analgesic activity, anti-inflammatory, antimalarial, antidiarrheal, antimutagenic, antihypertensive, antioxidant/free radical scavenging, diuretic, anti-amoebic, anthelmintic, antitubercular, antispasmodic, antiprotozoal, antifungal, and anti-giardia properties.[17]

Bilwa (A. marmelos Corr.) possess Kashaya Tikta Rasa, Laghu, Ruksha Guna, Ushana Virya, and Katu Vipaka. It is Deepana, Pachana, Graahi, and Vatakapha Shamana. It works on Grahani due to Grahi property; on Agni due to Laghu Guna Katu Vipaka and Deepana Guna. It has property of Amapachaka due to Tikta Rasa, Ushana Virya, and Laghu Guna.

It also possesses pharmacological actions such as antimicrobial, anti-inflammatory, antidiarrheal, antipyretic, analgesic, antidiabetic, hepatoprotective, and anticancer effects.[18]

Digestive heath capsule has Deepana, Pachana, Graahi, and Vatakapha Shamana properties along with anti-inflammatory, antidiarrheal, antispasmodic, antioxidant, analgesic activity, gut motility regulation, and immunomodulatory effect.

Conclusion

Based on Rogaprakriti, Adhishthana, and Samutthana as well as the clinical manifestations, Grahani Roga has a similarity with IBS. Vitiated Vata Dosha and the deranged status of Agni are the main components in the pathogenesis of Grahani Roga. No adverse or side effects were encountered during the study. Digestive health capsules are primarily found to be effective in the management of Grahani Roga as it has provided statistically significant relief in most of the symptoms. A further randomized controlled trial should be carried out to confirm the efficacy of Digestive health capsules in Grahani Roga.

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